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1. Proceedings of the 5th Asia dengue summit

Author

Srisawat, Nattachai, Gubler, Duane J, Pangestu, Tikki, Thisyakorn, Usa, Ismail, Zulkifli, Goh, Daniel, Capeding, Maria Rosario, Bravo, Lulu, Yoksan, Sutee, Tantawichien, Terapong, Hadinegoro, Sri Rezeki, Rafiq, Kamran, Picot, Valentina Sanchez, and Ooi, Eng Eong

Published
2023

2. Indirect effectiveness of a novel SARS-COV-2 vaccine (SCB-2019) in unvaccinated household contacts in the Philippines: A cluster randomised analysis

Author

Aziz, Asma Binte, Sugimoto, Jonathan Dewing, Hong, Sye Lim, You, Young Ae, Bravo, Lulu, Roa, Camilo, Jr, Borja-Tabora, Charissa, Montellano, May Emmeline B., Carlos, Josefina, de Los Reyes, Mari Rose A., Alberto, Edison R., Salvani-Bautista, Milagros, Kim, Hwa Young, Njau, Irene, Clemens, Ralf, Marks, Florian, and Tadesse, Birkneh Tilahun

Published
2024
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4. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4·5-year results from a phase 3, randomised, double-blind, placebo-controlled trial

Author

Tricou, Vianney, Yu, Delia, Reynales, Humberto, Biswal, Shibadas, Saez-Llorens, Xavier, Sirivichayakul, Chukiat, Lopez, Pio, Borja-Tabora, Charissa, Bravo, Lulu, Kosalaraksa, Pope, Vargas, Luis Martinez, Alera, Maria Theresa, Rivera, Luis, Watanaveeradej, Veerachai, Dietze, Reynaldo, Fernando, LakKumar, Wickramasinghe, V Pujitha, Moreira, Edson Duarte, Jr, Fernando, Asvini D, Gunasekera, Dulanie, Luz, Kleber, Oliveira, Ana Lucia, Tuboi, Suely, Escudero, Ian, Hutagalung, Yanee, Lloyd, Eric, Rauscher, Martina, Zent, Olaf, Folschweiller, Nicolas, LeFevre, Inge, Espinoza, Felix, and Wallace, Derek

Published
2024
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5. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial

Author

Bravo, Lulu, Smolenov, Igor, Han, Htay Htay, Li, Ping, Hosain, Romana, Rockhold, Frank, Clemens, Sue Ann Costa, Roa, Camilo, Jr, Borja-Tabora, Charissa, Quinsaat, Antoinette, Lopez, Pio, López-Medina, Eduardo, Brochado, Leonardo, Hernández, Eder A, Reynales, Humberto, Medina, Tatiana, Velasquez, Hector, Toloza, Leonardo Bautista, Rodriguez, Edith Johana, de Salazar, Dora Ines Molina, Rodríguez, Camilo A, Sprinz, Eduardo, Cerbino-Neto, José, Luz, Kleber Giovanni, Schwarzbold, Alexandre Vargas, Paiva, Maria Sanali, Carlos, Josefina, Montellano, May Emmeline B, de Los Reyes, Mari Rose A, Yu, Charles Y, Alberto, Edison R, Panaligan, Mario M, Salvani-Bautista, Milagros, Buntinx, Erik, Hites, Maya, Martinot, Jean-Benoit, Bhorat, Qasim E, Badat, Aysha, Baccarini, Carmen, Hu, Branda, Jurgens, Jaco, Engelbrecht, Jan, Ambrosino, Donna, Richmond, Peter, Siber, George, Liang, Joshua, and Clemens, Ralf

Published
2022
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6. Proceedings of the 6th Asia Dengue Summit, June 2023

Author

Srisawat, Nattachai, primary, Gubler, Duane J., additional, Pangestu, Tikki, additional, Limothai, Umaporn, additional, Thisyakorn, Usa, additional, Ismail, Zulkifli, additional, Goh, Daniel, additional, Capeding, Maria Rosario, additional, Bravo, Lulu, additional, Yoksan, Sutee, additional, Tantawichien, Terapong, additional, Hadinegoro, Sri Rezeki, additional, Rafiq, Kamran, additional, Picot, Valentina Sanchez, additional, and Ooi, Eng Eong, additional

Published
2024
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8. Safety and immunogenicity of SCB-2019, an adjuvanted, recombinant SARS-CoV-2 trimeric S-protein subunit COVID-19 vaccine in healthy 12–17 year-old adolescents

Author

Lopez, Pio, primary, Bravo, Lulu, additional, Buntinx, Erik, additional, Borja-Tabora, Charissa, additional, Velasquez, Hector, additional, Rodriquez, Edith Johana, additional, Rodriguez, Camilo A., additional, Carlos, Josefina, additional, Montellano, May Emmeline B., additional, Alberto, Edison R., additional, Salvani-Bautista, Milagros, additional, Huang, Yung, additional, Hu, Branda, additional, Li, Ping, additional, Han, Htay Htay, additional, Baccarini, Carmen, additional, and Smolenov, Igor, additional

Published
2023
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11. ASVAC2022 : 8 th Asian Vaccine Conference

Author

Galagoda, Geethani C. S., primary, Perera, Jennifer, additional, de Silva, Rajiva, additional, Wickramasinghe, H. T., additional, Dasanayake, Dhanushka, additional, Bravo, Lulu, additional, Ismail, Zulkifli, additional, Goh, Daniel Y. T., additional, and Nelson, E. Anthony S., additional

Published
2023
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13. Impact of Vaccination With the SCB-2019 Coronavirus Disease 2019 Vaccine on Transmission of Severe Acute Respiratory Syndrome Coronavirus 2 Infection: A Household Contact Study in the Philippines.

Author

Tadesse, Birkneh Tilahun, Bravo, Lulu, Marks, Florian, Aziz, Asma Binte, You, Young Ae, Sugimoto, Jonathan, Li, Ping, Garcia, Joyce, Rockhold, Frank, Clemens, Ralf, and Group, for the Household Contact Study

Subjects
*PREVENTION of infectious disease transmission, *HOME environment, *REVERSE transcriptase polymerase chain reaction, *RESEARCH, *COVID-19, *IMMUNIZATION, *CONFIDENCE intervals, *COVID-19 vaccines, *SEVERITY of illness index, *VACCINE effectiveness, *PLACEBOS, *COMPARATIVE studies, *DESCRIPTIVE statistics, *RESEARCH funding, *VIRAL antibodies, *ODDS ratio, *LONGITUDINAL method
Abstract

Background An exploratory household transmission study was nested in SPECTRA, the phase 2/3 efficacy study of the adjuvanted recombinant protein-based COVID-19 vaccine SCB-2019. We compared the occurrence of confirmed COVID-19 infections between households and household contacts of infected SPECTRA placebo or SCB-2019 recipients. Methods SPECTRA participants at 8 study sites in the Philippines who developed real-time reverse transcriptase–polymerase chain reaction (rRT-PCR)–confirmed COVID-19 were contacted by a study team blinded to assignment of index cases to vaccine or placebo groups to enroll in this household transmission study. Enrolled households and household contacts were monitored for 3 weeks using rRT-PCR and anti–SARS-CoV-2 N-antigen IgG/IgM testing to detect new COVID-19 infections. Results One hundred fifty-four eligible COVID-19 index cases (51 vaccinees, 103 placebo) were included. The secondary attack rate per household for symptomatic COVID-19 infection was 0.76% (90% CI:.15–3.90%) if the index case was an SCB-2019 vaccinee compared with 5.88% (90% CI: 3.20–10.8%) for placebo index cases, a relative risk reduction (RRR) of 79% (90% CI: −28% to 97%). The RRR of symptomatic COVID-19 per household member was similar: 84% (90% CI: 28–97%). The impact on attack rates in household members if index cases were symptomatic (n = 130; RRR = 80%; 90% CI: 7–96%) or asymptomatic (n = 24; RRR = 100%; 90% CI: −76% to 100%) was measurable but the low numbers undermine the clinical significance. Conclusions In this prospective household contact study vaccination with SCB-2019 reduced SARS-CoV-2 transmission compared with placebo in households and in household members independently of whether or not index cases were symptomatic. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Three-year Efficacy and Safety of Takeda’s Dengue Vaccine Candidate (TAK-003)

Author

Rivera, Luis, primary, Biswal, Shibadas, additional, Sáez-Llorens, Xavier, additional, Reynales, Humberto, additional, López-Medina, Eduardo, additional, Borja-Tabora, Charissa, additional, Bravo, Lulu, additional, Sirivichayakul, Chukiat, additional, Kosalaraksa, Pope, additional, Martinez Vargas, Luis, additional, Yu, Delia, additional, Watanaveeradej, Veerachai, additional, Espinoza, Felix, additional, Dietze, Reynaldo, additional, Fernando, LakKumar, additional, Wickramasinghe, Pujitha, additional, Duarte MoreiraJr, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Luz, Kleber, additional, Venâncioda Cunha, Rivaldo, additional, Rauscher, Martina, additional, Zent, Olaf, additional, Liu, Mengya, additional, Hoffman, Elaine, additional, LeFevre, Inge, additional, Tricou, Vianney, additional, Wallace, Derek, additional, Alera, MariaTheresa, additional, and Borkowski, Astrid, additional

Published
2021
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18. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study.

Author

Capeding, Maria Rosario, Gomez-Go, Grace Devota, Oberdorfer, Peninnah, Borja-Tabora, Charissa, Bravo, Lulu, Carlos, Josefina, Tangsathapornpong, Auchara, Uppala, Rattapon, Laoprasopwattana, Kamolwish, Yang, Yunjeong, Han, Song, and Wittawatmongkol, Orasri

Subjects
POLIO prevention, ENTEROVIRUSES, POLIOMYELITIS vaccines, RANDOMIZED controlled trials, RESEARCH funding, VIRAL antibodies, STATISTICAL sampling
Abstract

Background: A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative.Methods: This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination.Results: In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed.Conclusions: Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV.Clinical Trials Registration: NCT03169725. [ABSTRACT FROM AUTHOR]

Published
2022
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19. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003).

Author

Rivera, Luis, Biswal, Shibadas, Sáez-Llorens, Xavier, Reynales, Humberto, López-Medina, Eduardo, Borja-Tabora, Charissa, Bravo, Lulu, Sirivichayakul, Chukiat, Kosalaraksa, Pope, Vargas, Luis Martinez, Yu, Delia, Watanaveeradej, Veerachai, Espinoza, Felix, Dietze, Reynaldo, Fernando, LakKumar, Wickramasinghe, Pujitha, MoreiraJr, Edson Duarte, Fernando, Asvini D, Gunasekera, Dulanie, and Luz, Kleber

Subjects
DRUG efficacy, RESEARCH, REVERSE transcriptase polymerase chain reaction, DENGUE, VIRAL vaccines, CONFIDENCE intervals, TIME, SERODIAGNOSIS, RANDOMIZED controlled trials, DESCRIPTIVE statistics, DRUG side effects, PATIENT safety
Abstract

Background Takeda's live attenuated tetravalent dengue vaccine candidate (TAK-003) is under evaluation in a long-term clinical trial across 8 dengue-endemic countries. Previously, we have reported its efficacy and safety in both seronegative and seropositive participants and that its performance varies by serotype, with some decline in efficacy from first to second year postvaccination. This exploratory analysis provides an update with cumulative and third-year data. Methods Healthy 4–16 year olds (n = 20099) were randomized 2:1 to receive TAK-003 or placebo (0, 3 month schedule). The protocol included baseline serostatus testing of all participants and detection of all symptomatic dengue throughout the trial with a serotype specific reverse transcriptase-polymerase chain reaction. Results Cumulative efficacy after 3 years was 62.0% (95% confidence interval, 56.6–66.7) against virologically confirmed dengue (VCD) and 83.6% (76.8–88.4) against hospitalized VCD. Efficacy was 54.3% (41.9–64.1) against VCD and 77.1% (58.6–87.3) against hospitalized VCD in baseline seronegatives, and 65.0% (58.9–70.1) against VCD and 86.0% (78.4–91.0) against hospitalized VCD in baseline seropositives. Efficacy against VCD during the third year declined to 44.7% (32.5–54.7), whereas efficacy against hospitalized VCD was sustained at 70.8% (49.6–83.0). Rates of serious adverse events were 2.9% in TAK-003 group and 3.5% in placebo group during the ongoing long-term follow-up (ie, second half of the 3 years following vaccination), but none were related. No important safety risks were identified. Conclusions TAK-003 was efficacious against symptomatic dengue over 3 years. Efficacy declined over time but remained robust against hospitalized dengue. A booster dose evaluation is planned. [ABSTRACT FROM AUTHOR]

Published
2022
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20. Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination.

Author

López-Medina, Eduardo, Biswal, Shibadas, Saez-Llorens, Xavier, Borja-Tabora, Charissa, Bravo, Lulu, Sirivichayakul, Chukiat, Vargas, Luis Martinez, Alera, Maria Theresa, Velásquez, Hector, Reynales, Humberto, Rivera, Luis, Watanaveeradej, Veerachai, Rodriguez-Arenales, Edith Johana, Yu, Delia, Espinoza, Felix, Dietze, Reynaldo, Fernando, Lak Kumar, Wickramasinghe, Pujitha, Moreira, Edson Duarte, and Fernando, Asvini D

Subjects
VACCINE effectiveness, CLINICAL trial registries, TEENAGERS, VACCINATION, DENGUE, RESEARCH, VIRAL vaccines, IMMUNIZATION, IMMUNOGLOBULINS, VACCINES, FLAVIVIRUSES, RESEARCH methodology, EVALUATION research, COMPARATIVE studies, RANDOMIZED controlled trials, BLIND experiment, RESEARCH funding, VIRAL antibodies
Abstract

Background: Takeda's dengue vaccine is under evaluation in an ongoing phase 3 efficacy study; we present a 2-year update.Methods: Children (20 099, 4-16 years old) were randomized to receive 2 doses of TAK-003 or placebo 3 months apart and are under surveillance to detect dengue by serotype-specific RT-PCR.Results: Cumulative efficacy against dengue approximately 27 months since first dose was 72.7% (95% confidence interval [CI], 67.1%-77.3%), including 67.0% (95% CI, 53.6%-76.5%) in dengue-naive and 89.2% (95% CI, 82.4%-93.3%) against hospitalized dengue. In the second year, decline in efficacy was observed (56.2%; 95% CI, 42.3%-66.8%) with the largest decline in 4-5 year olds (24.5%; 95% CI, -34.2% to 57.5%); efficacy was 60.6% (95% CI, 43.8%-72.4%) in 6-11 year and 71.2% (95% CI, 41.0%-85.9%) in 12-16 year age groups. As TAK-003 efficacy varies by serotype, changes in serotype dominance partially contributed to efficacy differences in year-by-year analysis. No related serious adverse events occurred during the second year.Conclusions: TAK-003 demonstrated continued benefit independent of baseline serostatus in reducing dengue with some decline in efficacy during the second year. Three-year data will be important to see if efficacy stabilizes or declines further.Clinical Trials Registration. NCT02747927.Takeda's tetravalent dengue vaccine (TAK-003) continued to demonstrate benefit in reducing dengue independent of baseline serostatus up to 2 years after completing vaccination with some decline in efficacy during the second year in 4-16 year olds in dengue-endemic countries. [ABSTRACT FROM AUTHOR]

Published
2022
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23. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study

Author

Capeding, Maria Rosario, primary, Gomez-Go, Grace Devota, additional, Oberdorfer, Peninnah, additional, Borja-Tabora, Charissa, additional, Bravo, Lulu, additional, Carlos, Josefina, additional, Tangsathapornpong, Auchara, additional, Uppala, Rattapon, additional, Laoprasopwattana, Kamolwish, additional, Yang, Yunjeong, additional, Han, Song, additional, and Wittawatmongkol, Orasri, additional

Published
2020
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24. Efficacy of a Dengue Vaccine Candidate (TAK-003) in Healthy Children and Adolescents 2 Years after Vaccination

Author

López-Medina, Eduardo, primary, Biswal, Shibadas, additional, Saez-Llorens, Xavier, additional, Borja-Tabora, Charissa, additional, Bravo, Lulu, additional, Sirivichayakul, Chukiat, additional, Vargas, Luis Martinez, additional, Alera, Maria Theresa, additional, Velásquez, Hector, additional, Reynales, Humberto, additional, Rivera, Luis, additional, Watanaveeradej, Veerachai, additional, Rodriguez-Arenales, Edith Johana, additional, Yu, Delia, additional, Espinoza, Felix, additional, Dietze, Reynaldo, additional, Fernando, Lak Kumar, additional, Wickramasinghe, Pujitha, additional, Duarte Moreira, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Luz, Kleber, additional, da Cunha, Rivaldo Venâncio, additional, Tricou, Vianney, additional, Rauscher, Martina, additional, Liu, Mengya, additional, LeFevre, Inge, additional, Wallace, Derek, additional, Kosalaraksa, Pope, additional, and Borkowski, Astrid, additional

Published
2020
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25. Efficacy of a tetravalent dengue vaccine in healthy children aged 4–16 years: a randomised, placebo-controlled, phase 3 trial

Author

Biswal, Shibadas, primary, Borja-Tabora, Charissa, additional, Martinez Vargas, Luis, additional, Velásquez, Hector, additional, Theresa Alera, Maria, additional, Sierra, Victor, additional, Johana Rodriguez-Arenales, Edith, additional, Yu, Delia, additional, Wickramasinghe, V Pujitha, additional, Duarte Moreira, Edson, additional, Fernando, Asvini D, additional, Gunasekera, Dulanie, additional, Kosalaraksa, Pope, additional, Espinoza, Felix, additional, López-Medina, Eduardo, additional, Bravo, Lulu, additional, Tuboi, Suely, additional, Hutagalung, Yanee, additional, Garbes, Pedro, additional, Escudero, Ian, additional, Rauscher, Martina, additional, Bizjajeva, Svetlana, additional, LeFevre, Inge, additional, Borkowski, Astrid, additional, Saez-Llorens, Xavier, additional, Wallace, Derek, additional, Concepción, Alys, additional, Villarreal, Ana Cecilia, additional, Fernando, Asvini, additional, Sirivichayakul, Chukiat, additional, Rodriguez-Arenales, Edith Johanna, additional, Moreira, Edson Duarte, additional, Reynales, Humberto, additional, Luz, Kleber, additional, Jimeno, Jose, additional, Fernando, LakKumar, additional, Vargas, Luis Martinez, additional, Rivera, Luis, additional, Alera, Maria Theresa, additional, Manacharoen, Onanong, additional, Lopez, Pio, additional, Wickramasinghe, V. Pujitha, additional, Dietze, Reynaldo, additional, da Cunha, Rivaldo Venâncio, additional, Watanaveeradej, Veerachai, additional, Biswal, Shibadas, additional, Brose, Manja, additional, Moss, Kelley, additional, Meyer, Seetha, additional, and Tricou, Vianney, additional

Published
2020
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27. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age

Author

Bravo, Lulu C., primary, Carlos, Josefina C., additional, Gatchalian, Salvacion R., additional, Montellano, May Emmeline B., additional, Tabora, Charissa Fay Corazon B., additional, Thierry-Carstensen, Birgit, additional, Tingskov, Pernille Nyholm, additional, Sørensen, Charlotte, additional, Wachmann, Henrik, additional, Bandyopadhyay, Ananda S., additional, Nielsen, Pernille Ingemann, additional, and Kusk, Mie Vestergaard, additional

Published
2020
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29. Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents

Author

Biswal, Shibadas, primary, Reynales, Humberto, additional, Saez-Llorens, Xavier, additional, Lopez, Pio, additional, Borja-Tabora, Charissa, additional, Kosalaraksa, Pope, additional, Sirivichayakul, Chukiat, additional, Watanaveeradej, Veerachai, additional, Rivera, Luis, additional, Espinoza, Felix, additional, Fernando, LakKumar, additional, Dietze, Reynaldo, additional, Luz, Kleber, additional, Venâncio da Cunha, Rivaldo, additional, Jimeno, José, additional, López-Medina, Eduardo, additional, Borkowski, Astrid, additional, Brose, Manja, additional, Rauscher, Martina, additional, LeFevre, Inge, additional, Bizjajeva, Svetlana, additional, Bravo, Lulu, additional, and Wallace, Derek, additional

Published
2019
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30. Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Author

Pepin, Stephanie Dupuy, Martin Corazon Borja-Tabora, Charissa Fay Montellano, May Bravo, Lulu Santos, Jaime de Castro, Jo-Anne Rivera-Medina, Doris Maribel Cutland, Clare Ariza, Miguel Diez-Domingo, Javier Diaz Gonzalez, Celia and Martinon-Torres, Federico Papadopoulou-Alataki, Efimia and Theodoriado, Maria Kazek-Duret, Marie Pierre Gurunathan, Sanjay and De Bruijn, Iris Abalos, Karina Aurell, Helena Maria Baldo, Jose Bona, Gianni Angel, Miguel Cadorna-Carlos, Josefina Cangrejo, Marcela Capilna, Brindusa Ruxandra Cara, Alexandra Carmen Carmona Martinez, Alfonso Chemin, Frederic and Closa, Ricardo Cots, Manuel Baca Coux, Florence and Diez-Domingo, Javier Dracea, Laura Larisa Emporiadou, Maria and Espiau, Maria Esposito, Susanna Pecurariu, Oana Asso Falup and Garces-Sanchez, Maria Garg, Sanjay Gil, Amparo Gonzales, Laurie Guevel, Ronan Guillen, Sara Icardi, Giancarlo and Laot, Thelma Lacroix, Isabelle Mares, Josep Martinez Pons, Manuel Moreau, Catherine Neamtu, Mihai Leonida Neculau, Andrea Elena Ojeda, Joyce Papaevangelou, Vana Penon, Maria Gabriella Petit, Celine Philibert, Marie Planelles Cantarino, Victoria Py, Marie-Laure Ramos, Jose T. Rivas, Enrique Roilides, Emmanouel Rosich, Angels Salamand, Camille and Suarez, Eva Surdu, Gabriel Doru Cerdan Vera, Teresa and Tsolia, Mariza Vicedo, Mira Woods, Anne GQM05 Study Grp

Abstract

Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetre (TM), Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged >= 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months. Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent splitvirion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains. Results: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo. Conclusions: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains. (C) 2018 The Authors. Published by Elsevier Ltd.

Published
2019

31. Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Author

Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Pepin, Stephanie, Dupuy, Martin, Borja-Tobora, Charissa Fay Corazon, Montellano, May, Bravo, Lulu, Santos, Jaime, Castro, Jo-Anne de, Rivera-Medina, Doris Maribel, Cutland, Clare, Ariza, Miguel, Díez-Domingo, Javier, Díaz González, Celia, Martinón Torres, Federico, Papadopoulou-Alataki, Efimia, Theodoriadou, Maria, Kazek-Duret, Marie Pierre, Gurunathan, Sanjay, de Bruijn, Iris, Universidade de Santiago de Compostela. Departamento de Ciencias Forenses, Anatomía Patolóxica, Xinecoloxía e Obstetricia, e Pediatría, Pepin, Stephanie, Dupuy, Martin, Borja-Tobora, Charissa Fay Corazon, Montellano, May, Bravo, Lulu, Santos, Jaime, Castro, Jo-Anne de, Rivera-Medina, Doris Maribel, Cutland, Clare, Ariza, Miguel, Díez-Domingo, Javier, Díaz González, Celia, Martinón Torres, Federico, Papadopoulou-Alataki, Efimia, Theodoriadou, Maria, Kazek-Duret, Marie Pierre, Gurunathan, Sanjay, and de Bruijn, Iris

Abstract

Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6–35 months. Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6–35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains. Results: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36–61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07–81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo. Conclusions: IIV4 was safe and effective for protecting children aged 6–35 months against influenza illness caused by vaccine-similar or any circulating strains

Published
2019

33. Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6–35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres

Author

Pepin, Stephanie, primary, Dupuy, Martin, additional, Borja-Tabora, Charissa Fay Corazon, additional, Montellano, May, additional, Bravo, Lulu, additional, Santos, Jaime, additional, de Castro, Jo-Anne, additional, Rivera-Medina, Doris Maribel, additional, Cutland, Clare, additional, Ariza, Miguel, additional, Diez-Domingo, Javier, additional, Gonzalez, Celia Diaz, additional, Martinón-Torres, Federico, additional, Papadopoulou-Alataki, Efimia, additional, Theodoriadou, Maria, additional, Kazek-Duret, Marie Pierre, additional, Gurunathan, Sanjay, additional, and De Bruijn, Iris, additional

Published
2019
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34. Prevention of vaccine-matched and mismatched influenza in children aged 6–35 months: a multinational randomised trial across five influenza seasons

Author

UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de gastro-entérologie et hépatologie pédiatrique, Claeys, Carine, Zaman, Khalequ, Dbaibo, Ghassan, Li, Ping, Izu, Allen, Kosalaraksa, Pope, Rivera, Luis, Acosta, Beatriz, Arroba Basanta, Maria Luisa, Aziz, Asma, Cabanero, Miguel Angel, Chandrashekaran, Vijayalakshmi, Corsaro, Bartholomew, Cousin, Luis, Diaz, Adolfo, Diez-Domingo, Javier, Dinleyici, Ener Cagri, Faust, Saul N, Friel, Damien, Garcia-Sicilia, Jose, Gomez-Go, Grace D, Antoinette Gonzales, Maria Liza, Hughes, Stephen M, Jackowska, Teresa, Kant, Shashi, Lucero, Marilla, Malvaux, Ludovic, Mares Bermudez, Josep, Martinon-Torres, Federico, Miranda, Mariano, Montellano, May, Peix Sambola, Maria Amor, Prymula, Roman, Puthanakit, Thanyawee, Ruzkova, Renata, Sadowska-Krawczenko, Iwona, Salamanca de la Cueva, Ignacio, Sokal, Etienne, Soni, Jyoti, Szymanski, Henryk, Ulied, Angels, Schuind, Anne, Jain, Varsha K, Innis, Bruce L, Acostas, Beatriz, Amanullah, Arshad, Ariza, Miguel, Bautista, Milagros, Bavdekar, Ashish, Bodalia, Bhavesh, Bravo, Lulu C, Brzostek, Jerzy, Caldwell, Ian, Carmona, Alfonso, Danier, Jasur, Diaz Cirujano, Ana Isabel, Docx, Martine, Drazan, Daniel, Galaj, Andrzej, Garcia Rodriguez, Fermin, Gonzales, Maria Liza Antoinette, Gooding, Trevor, Hacimustafaoglu, Mustafa, Heath, Paul, Heaton, Paul, Lalwani, Sanjay, Langlands, Jennifer, Logghe, Karl, Mantyka, Jolanta, McNally, Damien, Miszczak-Kowalska, Edyta, Royal, Simon, Sablan, Benjamin, Snape, Matthew, Tomlinson, Richard, Verghote, Marc, Vertruyen, Andre, Wheeler, Marie, UCL - SSS/IREC/PEDI - Pôle de Pédiatrie, UCL - (SLuc) Service de gastro-entérologie et hépatologie pédiatrique, Claeys, Carine, Zaman, Khalequ, Dbaibo, Ghassan, Li, Ping, Izu, Allen, Kosalaraksa, Pope, Rivera, Luis, Acosta, Beatriz, Arroba Basanta, Maria Luisa, Aziz, Asma, Cabanero, Miguel Angel, Chandrashekaran, Vijayalakshmi, Corsaro, Bartholomew, Cousin, Luis, Diaz, Adolfo, Diez-Domingo, Javier, Dinleyici, Ener Cagri, Faust, Saul N, Friel, Damien, Garcia-Sicilia, Jose, Gomez-Go, Grace D, Antoinette Gonzales, Maria Liza, Hughes, Stephen M, Jackowska, Teresa, Kant, Shashi, Lucero, Marilla, Malvaux, Ludovic, Mares Bermudez, Josep, Martinon-Torres, Federico, Miranda, Mariano, Montellano, May, Peix Sambola, Maria Amor, Prymula, Roman, Puthanakit, Thanyawee, Ruzkova, Renata, Sadowska-Krawczenko, Iwona, Salamanca de la Cueva, Ignacio, Sokal, Etienne, Soni, Jyoti, Szymanski, Henryk, Ulied, Angels, Schuind, Anne, Jain, Varsha K, Innis, Bruce L, Acostas, Beatriz, Amanullah, Arshad, Ariza, Miguel, Bautista, Milagros, Bavdekar, Ashish, Bodalia, Bhavesh, Bravo, Lulu C, Brzostek, Jerzy, Caldwell, Ian, Carmona, Alfonso, Danier, Jasur, Diaz Cirujano, Ana Isabel, Docx, Martine, Drazan, Daniel, Galaj, Andrzej, Garcia Rodriguez, Fermin, Gonzales, Maria Liza Antoinette, Gooding, Trevor, Hacimustafaoglu, Mustafa, Heath, Paul, Heaton, Paul, Lalwani, Sanjay, Langlands, Jennifer, Logghe, Karl, Mantyka, Jolanta, McNally, Damien, Miszczak-Kowalska, Edyta, Royal, Simon, Sablan, Benjamin, Snape, Matthew, Tomlinson, Richard, Verghote, Marc, Vertruyen, Andre, and Wheeler, Marie

Abstract

BACKGROUND: Despite the importance of vaccinating children younger than 5 years, few studies evaluating vaccine prevention of influenza have been reported in this age group. We evaluated efficacy of an inactivated quadrivalent influenza vaccine (IIV4) in children aged 6-35 months. METHODS: In this phase 3, observer-blinded, multinational trial, healthy children from 13 countries in Europe, Central America, and Asia were recruited in five independent cohorts, each in a different influenza season. Participants were randomly assigned (1:1) to either IIV4 (15 μg haemagglutinin antigen per strain per 0·5 mL dose; a single dose on day 0 for vaccine-primed children, and two doses, on days 0 and 28, for vaccine-unprimed children) or to one or two doses of a non-influenza control vaccine. Primary endpoints were moderate-to-severe influenza or all influenza (irrespective of disease severity) confirmed by RT-PCR on nasal swabs. Cultured isolates were further characterised as antigenically matched or mismatched to vaccine strains. Efficacy was assessed in the per-protocol cohort and total vaccinated cohort (time-to-event analysis), and safety was assessed in the total vaccinated cohort. FINDINGS: Between Oct 1, 2011, and Dec 31, 2014, 12 018 children were recruited into the total vaccinated cohort (6006 children in the IIV4 group and 6012 children in the control group). 356 (6%) children in the IIV4 group and 693 (12%) children in the control group had at least one case of RT-PCR-confirmed influenza. Of these 1049 influenza strains, 138 (13%) were A/H1N1, 529 (50%) were A/H3N2, 69 (7%) were B/Victoria, and 316 (30%) were B/Yamagata. Overall, 539 (64%) of 848 antigenically characterised isolates were vaccine-mismatched (16 [15%] of 105 for A/H1N1; 368 [97%] of 378 for A/H3N2; 54 [86%] of 63 for B/Victoria; 101 [33%] of 302 for B/Yamagata). Vaccine efficacy was 63% (97·5% CI 52-72) against moderate-to-severe influenza and 50% (42-57) against all influenza in the per-protocol coho

Published
2018

35. Prevention of vaccine-matched and mismatched influenza in children aged 6–35 months: a multinational randomised trial across five influenza seasons

Author

Claeys, Carine, primary, Zaman, Khalequ, additional, Dbaibo, Ghassan, additional, Li, Ping, additional, Izu, Allen, additional, Kosalaraksa, Pope, additional, Rivera, Luis, additional, Acosta, Beatriz, additional, Arroba Basanta, Maria Luisa, additional, Aziz, Asma, additional, Cabanero, Miguel Angel, additional, Chandrashekaran, Vijayalakshmi, additional, Corsaro, Bartholomew, additional, Cousin, Luis, additional, Diaz, Adolfo, additional, Diez-Domingo, Javier, additional, Dinleyici, Ener Cagri, additional, Faust, Saul N, additional, Friel, Damien, additional, Garcia-Sicilia, Jose, additional, Gomez-Go, Grace D, additional, Antoinette Gonzales, Maria Liza, additional, Hughes, Stephen M, additional, Jackowska, Teresa, additional, Kant, Shashi, additional, Lucero, Marilla, additional, Malvaux, Ludovic, additional, Mares Bermudez, Josep, additional, Martinon-Torres, Federico, additional, Miranda, Mariano, additional, Montellano, May, additional, Peix Sambola, Maria Amor, additional, Prymula, Roman, additional, Puthanakit, Thanyawee, additional, Ruzkova, Renata, additional, Sadowska-Krawczenko, Iwona, additional, Salamanca de la Cueva, Ignacio, additional, Sokal, Etienne, additional, Soni, Jyoti, additional, Szymanski, Henryk, additional, Ulied, Angels, additional, Schuind, Anne, additional, Jain, Varsha K, additional, Innis, Bruce L, additional, Acostas, Beatriz, additional, Amanullah, Arshad, additional, Ariza, Miguel, additional, Bautista, Milagros, additional, Bavdekar, Ashish, additional, Bodalia, Bhavesh, additional, Bravo, Lulu C, additional, Brzostek, Jerzy, additional, Caldwell, Ian, additional, Carmona, Alfonso, additional, Claeys, Carine, additional, Danier, Jasur, additional, Diaz Cirujano, Ana Isabel, additional, Docx, Martine, additional, Drazan, Daniel, additional, Galaj, Andrzej, additional, Garcia Rodriguez, Fermin, additional, Gonzales, Maria Liza Antoinette, additional, Gooding, Trevor, additional, Hacimustafaoglu, Mustafa, additional, Heath, Paul, additional, Heaton, Paul, additional, Lalwani, Sanjay, additional, Langlands, Jennifer, additional, Logghe, Karl, additional, Mantyka, Jolanta, additional, McNally, Damien, additional, Miszczak-Kowalska, Edyta, additional, Royal, Simon, additional, Sablan, Benjamin, additional, Snape, Matthew, additional, Tomlinson, Richard, additional, Verghote, Marc, additional, Vertruyen, Andre, additional, and Wheeler, Marie, additional

Published
2018
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37. Recent Epidemiological Trends of Dengue in the French Territories of the Americas (2000–2012): A Systematic Literature Review

Author

Bravo, Lulu, Roque, Vito G., Brett, Jeremy, Dizon, Ruby, and L'Azou, Maïna

Subjects
Genotype, Epidemiology, Incidence, Philippines, Dengue Virus, Environment, Serogroup, Dengue, Age Distribution, Seroepidemiologic Studies, Medicine and Health Sciences, Humans, Seasons, Sex Distribution, Research Article
Abstract

This literature analysis describes the available dengue epidemiology data in the Philippines between 2000 and 2011. Of 253 relevant data sources identified, 34, including additional epidemiology data provided by the National Epidemiology Center, Department of Health, Philippines, were reviewed. There were 14 publications in peer reviewed journals, and 17 surveillance reports/sources, which provided variable information from the passive reporting system and show broad trends in dengue incidence, including age group predominance and disease severity. The peer reviewed studies focused on clinical severity of cases, some revealed data on circulating serotypes and genotypes and on the seroepidemiology of dengue including incidence rates for infection and apparent disease. Gaps in the data were identified, and include the absence incidence rates stratified by age, dengue serotype and genotype distribution, disease severity data, sex distribution data, and seroprevalence data. Protocol registration PROSPERO CRD42012002292, Author Summary Dengue disease is a tropical and subtropical mosquito-borne viral illness and is a major health concern in the Philippines. To determine the dengue disease burden in the Philippines and identify gaps and future research needs, we conducted a literature analysis and review to describe the epidemiology of dengue disease. We used well-defined methods to search and identify relevant research conducted between 2000 and 2011. This long-term review highlights an increase in the reported incidence of dengue disease in the Philippines. The rising incidence of dengue disease may be related to a growing population, increasing urbanization, improvements in surveillance, and the limited success of vector control measures. Gaps in the epidemiological information available in the Philippines during the period 2000–2011 include comprehensive national and regional data that describe the proportion of severe dengue disease, including hospitalizations and mortality, and incidence data per 100,000 population. More comprehensive data are also needed for age, serotype, and seroprevalence on both national and regional levels. The data presented enable the observation of epidemiological characteristics, both within and across years. Such assessments are essential at national and regional levels to improve both preparedness and response activities relating to dengue disease outbreaks.

Published
2014

38. ASVAC2022 : 8thAsian Vaccine Conference

Author

Galagoda, Geethani C. S., Perera, Jennifer, de Silva, Rajiva, Wickramasinghe, H. T., Dasanayake, Dhanushka, Bravo, Lulu, Ismail, Zulkifli, Goh, Daniel Y. T., and Nelson, E. Anthony S.

Abstract

ABSTRACTAiming to further the Immunization Partners in Asia Pacific (IPAP)’s vision of a world where no one suffers from a vaccine preventable disease, the 8thAsian Vaccine Conference (ASVAC 2022) was held in Colombo, Sri Lanka and virtually from 15 to 18, September 2022 (www.asianvaccine.com). This conference followed those held in Siem Reap, Cambodia (2009), Manila, Philippines (2010), Jakarta, Indonesia (2011), Cebu, Philippines (2013), Hanoi, Vietnam (2015), Singapore (2017) and Naypyidaw and Yangon, Myanmar (2019). The ASVAC2022 themed “Immunization: in Era of Pandemics,” commenced with the EPI Managers’ Workshop, followed by pre-conference workshops and Vaccinology Masterclass, followed by the main conference featuring 5 plenary lectures, 6 partner-led symposia, free paper and poster presentations, and industry-supported lunch and evening sessions. There were over 1830 registered participants, with 112 attending in person and 998 virtually from 63 countries. The conference was organized by IPAP and hosted by the Vaccine and Infectious Disease Forum of Sri Lanka, Sri Lanka College of Pediatricians, Sri Lanka College of Microbiologists and College of General Practitioners of Sri Lanka, with the support of the Ministry of Health, Sri Lanka. The 9thASVAC is scheduled to be held in Davao City, Philippines in late 2023.

Published
2023
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42. Reactogenicity and safety of the human rotavirus vaccine,Rotarix™ in The Philippines, Sri Lanka, and India: A post-marketing surveillance study

Author

Bravo, Lulu, primary, Chitraka, Amarjeet, additional, Liu, Aixue, additional, Choudhury, Jaydeep, additional, Kumar, Kishore, additional, Berezo, Lennie, additional, Cimafranca, Leonard, additional, Chatterjee, Pallab, additional, Garg, Pankaj, additional, Siriwardene, Prasanna, additional, Bernardo, Rommel, additional, Mehta, Shailesh, additional, Balasubramanian, Sundaram, additional, Karkada, Naveen, additional, and Htay Han, Htay, additional

Published
2014
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48. A Randomized DoubleBlind Clinical Trial of a MaltodextrinContaining Oral Rehydration Solution in Acute Infantile Diarrhea

Author

Ocampo, Perla D. Santos, Bravo, Lulu C., Rogacion, Jossie M., and Battad, Grace R.

Abstract

A doubleblind, randomized controlled study was used to compare the efficacy and safety of an oral rehydration solution either with minimally hydrolyzed maltodextrins or the standard recommended glucose. One hundred twenty pediatric patients with acute watery diarrhea 60 in each group were studied, but only 116 patients were included in the final analysis. After rehydration, outcome variables did not differ significantly at p < 0.05. Mean duration of diarrhea was 52.5 ± 32.2 h for the control group median, 50.8 h and 57.2 ± hours for the study group median, 45.3 hours. Comparisons of the mean stool output, weight gain, and ORS intake on the 24th h and from admission to discharge were not statistically significant. Differences in laboratory parameters consisting of mean serum sodium, potassium, total C02, hematocrit, plasma total solids, urine specific gravity, and random blood sugar were likewise not significant. Differences in stool pH and reducing sugars were statistically significant however, the observed values were still within normal range. All laboratory values improved upon rehydration. Replacement of glucose with maltodextrins did not offer added advantages in reducing the duration and severity of diarrhea.

Published
1993

49. Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination.

Author

Sirivichayakul C, Biswal S, Saez-Llorens X, López-Medina E, Borja-Tabora C, Bravo L, Kosalaraksa P, Alera MT, Reynales H, Rivera L, Watanaveeradej V, Yu D, Espinoza F, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Venâncio da Cunha R, Oliveira AL, Rauscher M, Fan H, Borkowski A, Escudero I, Tuboi S, Lloyd E, Tricou V, Folschweiller N, LeFevre I, Vargas LM, and Wallace D

Abstract

Background: We explored the impact of prior Yellow fever (YF) or Japanese encephalitis (JE) vaccination on the efficacy of Takeda's dengue vaccine candidate, TAK-003 (NCT02747927)., Methods: Children 4-16 years of age were randomized 2:1 to receive TAK-003 or placebo and were under active febrile surveillance. Symptomatic dengue was confirmed by serotype-specific RT-PCR. YF and JE vaccination history was recorded., Results: Of the 20,071 children who received TAK-003 or placebo, 21.1% had a YF and 23.9% had a JE vaccination history at randomization. Fifty-seven months after vaccination, vaccine efficacy was 55.7% (95% CI, 39.7%-67.5%) in those with YF vaccination, 77.8% (70.8%-83.1%) for JE vaccination, and 53.5% (45.4%-60.4%) for no prior YF/JE vaccination. Regional differences in serotype distribution confound these results. The apparent higher vaccine efficacy in the JE vaccination subgroup could be largely explained by serotype-specific efficacy of TAK-003. Within 28 days of any vaccination, the proportions of participants with serious adverse events in the YF/JE prior vaccination population were comparable between the TAK-003 and placebo groups., Conclusions: The available data do not suggest a clinically relevant impact of prior JE or YF vaccination on TAK-003 performance. Overall, TAK-003 was well-tolerated and efficacious in different epidemiological settings., (© The Author(s) 2024. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Published
2024
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50. Priorities and challenges for hepatitis B control in the Philippines and the importance of a vaccine dose at birth.

Author

Ruff TA, Bravo L, Gatchalian SR, and Bock HL

Subjects
BCG Vaccine administration & dosage, Female, Health Priorities, Hepatitis B epidemiology, Hepatitis B transmission, Hepatitis B Vaccines supply & distribution, Humans, Infant, Newborn, Infectious Disease Transmission, Vertical prevention & control, Philippines epidemiology, Pregnancy, Pregnancy Complications, Infectious prevention & control, Communicable Disease Control organization & administration, Hepatitis B prevention & control, Hepatitis B Vaccines administration & dosage, Immunization Programs organization & administration, Immunization Schedule
Abstract

The Philippines annual birth cohort of over 2 million is the second largest in the Western Pacific Region; 44% of births occur outside health facilities. With third dose infant hepatitis B (HB) vaccine coverage of 43% in 2006, erratic vaccine supply, and lack of policies or processes for universal HB vaccine birth dose delivery, a substantial burden of preventable chronic HB infection continues to occur. Funding, policy, technical and immunization delivery developments now make substantial progress in HB control in the Philippines possible. These developments can help expand access to trained birth care and essential postnatal care for mothers and their newborn.

Published
2009

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