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1. Safety and immunogenicity of RTS, S/AS02D malaria vaccine in infants

Author

Abdulla, Salim, Oberholzer, Rolf, Juma, Omar, Kubhoja, Sulende, Machera, Francisca, Membi, Chritopher, Omari, Said, Urassa, Alwisa, Mshinda, Hassan, Jumanne, Ajuza, Salim, Nahya, Shomari, Mwanjaa, Aebi, Thomas, Schellenberg, David M., Carter, Terrell, Villafana, Tonya, Demoitie, Marie-Ange, Dubois, Marie-Claude, Leach, Amanda, Lievens, Marc, Vekemans, Johan, Cohen, Joe, Ballou, W. Ripley, and Tanner, Marcel

Subjects
Malaria vaccine -- Evaluation, Malaria vaccine -- Usage, Malaria vaccine -- Health aspects, Malaria -- Prevention
Abstract

The study aims to investigate the feasibility of integrating the RTS, S/AS02D malaria vaccine as part of the World Health Organization (WHO's) Extended Program on Immunization (EPI). The results indicate that the RTS, S/AS02D can be used as part of the EPI as it is quite effective in reducing the incidence of malaria.

Published
2008

2. Safety and Immunogenicity of RTS,S/AS02D Malaria Vaccine in Infants

Author

Abdulla, Salim, Oberholzer, Rolf, Juma, Omar, Kubhoja, Sulende, Machera, Francisca, Membi, Christopher, Omari, Said, Urassa, Alwisa, Mshinda, Hassan, Jumanne, Ajuza, Salim, Nahya, Shomari, Mwanjaa, Aebi, Thomas, Schellenberg, David M., Carter, Terrell, Villafana, Tonya, Demoitié, Marie-Ange, Dubois, Marie-Claude, Leach, Amanda, Lievens, Marc, Vekemans, Johan, Cohen, Joe, Ballou, Ripley W., and Tanner, Marcel

Published
2008
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3. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

Author

Abdulla Salim, Salim Nahya, Machera Francisca, Kamata Richard, Juma Omar, Shomari Mwanajaa, Kubhoja Sulende, Mohammed Ali, Mwangoka Grace, Aebi Thomas, Mshinda Hassan, Schellenberg David, Carter Terrell, Villafana Tonya, Dubois Marie-Claude, Leach Amanda, Lievens Marc, Vekemans Johan, Cohen Joe, Ballou W Ripley, and Tanner Marcel

Subjects
RTS,S/AS02, Falciparum, Malaria, Infants, Immunogenicity, Safety, Efficacy, EPI, Arctic medicine. Tropical medicine, RC955-962, Infectious and parasitic diseases, RC109-216
Abstract

Abstract Background The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. Methods This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. Results From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p = 0.545). Conclusions The acceptable safety profile and good tolerability of RTS,S/AS02D in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02D group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02D prevented approximately a quarter of malaria cases in the study population. Clinical trials Gov identifier: NCT00289185

Published
2013
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4. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children

Author

RTS,S Clinical Trials Partnership, Agnandji, Selidji Todagbe, Lell, Bertrand, Soulanoudjingar, Solange Solmeheim, Fernandes, José Francisco, Abossolo, Béatrice Peggy, Conzelmann, Cornelia, Methogo, Barbara Gaelle Nfono Ondo, Doucka, Yannick, Flamen, Arnaud, Mordmüller, Benjamin, Issifou, Saadou, Kremsner, Peter Gottfried, Sacarlal, Jahit, Aide, Pedro, Lanaspa, Miguel, Aponte, John J, Nhamuave, Arlindo, Quelhas, Diana, Bassat, Quique, Mandjate, Sofia, Macete, Eusébio, Alonso, Pedro, Abdulla, Salim, Salim, Nahya, Juma, Omar, Shomari, Mwanajaa, Shubis, Kafuruki, Machera, Francisca, Hamad, Ali Said, Minja, Rose, Mtoro, Ali, Sykes, Alma, Ahmed, Saumu, Urassa, Alwisa Martin, Ali, Ali Mohammed, Mwangoka, Grace, Tanner, Marcel, Tinto, Halidou, D'Alessandro, Umberto, Sorgho, Hermann, Valea, Innocent, Tahita, Marc Christian, Kaboré, William, Ouédraogo, Sayouba, Sandrine, Yara, Guiguemdé, Robert Tinga, Ouédraogo, Jean Bosco, Hamel, Mary J, Kariuki, Simon, Odero, Chris, Oneko, Martina, Otieno, Kephas, Awino, Norbert, Omoto, Jackton, Williamson, John, Muturi-Kioi, Vincent, Laserson, Kayla F, Slutsker, Laurence, Otieno, Walter, Otieno, Lucas, Nekoye, Otsyula, Gondi, Stacey, Otieno, Allan, Ogutu, Bernhards, Wasuna, Ruth, Owira, Victorine, Jones, David, Onyango, Agnes Akoth, Njuguna, Patricia, Chilengi, Roma, Akoo, Pauline, Kerubo, Christine, Gitaka, Jesse, Maingi, Charity, Lang, Trudie, Olotu, Ally, Tsofa, Benjamin, Bejon, Philip, Peshu, Norbert, Marsh, Kevin, Owusu-Agyei, Seth, Asante, Kwaku Poku, Osei-Kwakye, Kingsley, Boahen, Owusu, Ayamba, Samuel, Kayan, Kingsley, Owusu-Ofori, Ruth, Dosoo, David, Asante, Isaac, Adjei, George, Chandramohan, Daniel, Greenwood, Brian, Lusingu, John, Gesase, Samwel, Malabeja, Anangisye, Abdul, Omari, Kilavo, Hassan, Mahende, Coline, Liheluka, Edwin, Lemnge, Martha, Theander, Thor, Drakeley, Chris, Ansong, Daniel, Agbenyega, Tsiri, Adjei, Samuel, Boateng, Harry Owusu, Rettig, Theresa, Bawa, John, Sylverken, Justice, Sambian, David, Agyekum, Alex, Owusu, Larko, Martinson, Francis, Hoffman, Irving, Mvalo, Tisungane, Kamthunzi, Portia, Nkomo, Ruthendo, Msika, Albans, Jumbe, Allan, Chome, Nelecy, Nyakuipa, Dalitso, Chintedza, Joseph, Ballou, W Ripley, Bruls, Myriam, Cohen, Joe, Guerra, Yolanda, Jongert, Erik, Lapierre, Didier, Leach, Amanda, Lievens, Marc, Ofori-Anyinam, Opokua, Vekemans, Johan, Carter, Terrell, Leboulleux, Didier, Loucq, Christian, Radford, Afiya, Savarese, Barbara, Schellenberg, David, Sillman, Marla, and Vansadia, Preeti

Subjects
parasitic diseases
Abstract

BACKGROUND: An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries. METHODS: From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories. RESULTS: In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64). CONCLUSIONS: The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).

Published
2011

5. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/AS02D malaria vaccine in infants living in a malaria-endemic region

Author

Abdulla, Salim, Salim, Nahya, Machera, Francisca, Kamata, Richard, Juma, Omar, Shomari, Mwanajaa, Kubhoja, Sulende, Mohammed, Ali, Mwangoka, Grace, Aebi, Thomas, Mshinda, Hassan, Schellenberg, David, Carter, Terrell, Villafana, Tonya, Dubois, Marie-Claude, Leach, Amanda J., Lievens, Marc, Vekemans, Johan, Cohen, Joe, Ballou, W. Ripley, et al., Abdulla, Salim, Salim, Nahya, Machera, Francisca, Kamata, Richard, Juma, Omar, Shomari, Mwanajaa, Kubhoja, Sulende, Mohammed, Ali, Mwangoka, Grace, Aebi, Thomas, Mshinda, Hassan, Schellenberg, David, Carter, Terrell, Villafana, Tonya, Dubois, Marie-Claude, Leach, Amanda J., Lievens, Marc, Vekemans, Johan, Cohen, Joe, Ballou, W. Ripley, and et al.

Abstract

BackgroundThe RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. MethodsThis Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. ResultsFrom month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population

Published
2013

6. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children

Author

Agnandji, Selidji Todagbe, Lell, Bertrand, Soulanoudjingar, Solange Solmeheim, Fernandes, José Francisco, Abossolo, Béatrice Peggy, Conzelmann, Cornelia, Methogo, Barbara Gaelle Nfono Ondo, Doucka, Yannick, Flamen, Arnaud, Mordmüller, Benjamin, Issifou, Saadou, Kremsner, Peter Gottfried, Sacarlal, Jahit, Aide, Pedro, Lanaspa, Miguel, Aponte, John J, Nhamuave, Arlindo, Quelhas, Diana, Bassat, Quique, Mandjate, Sofia, Macete, Eusébio, Alonso, Pedro, Abdulla, Salim, Salim, Nahya, Juma, Omar, Shomari, Mwanajaa, Shubis, Kafuruki, Machera, Francisca, Hamad, Ali Said, Minja, Rose, Mtoro, Ali, Sykes, Alma, Ahmed, Saumu, Urassa, Alwisa Martin, Ali, Ali Mohammed, Mwangoka, Grace, Tanner, Marcel, Tinto, Halidou, D'Alessandro, Umberto, Sorgho, Hermann, Valea, Innocent, Tahita, Marc Christian, Kaboré, William, Ouédraogo, Sayouba, Sandrine, Yara, Guiguemdé, Robert Tinga, Ouédraogo, Jean Bosco, Hamel, Mary J, Lusingu, John, Theander, Thor, Agnandji, Selidji Todagbe, Lell, Bertrand, Soulanoudjingar, Solange Solmeheim, Fernandes, José Francisco, Abossolo, Béatrice Peggy, Conzelmann, Cornelia, Methogo, Barbara Gaelle Nfono Ondo, Doucka, Yannick, Flamen, Arnaud, Mordmüller, Benjamin, Issifou, Saadou, Kremsner, Peter Gottfried, Sacarlal, Jahit, Aide, Pedro, Lanaspa, Miguel, Aponte, John J, Nhamuave, Arlindo, Quelhas, Diana, Bassat, Quique, Mandjate, Sofia, Macete, Eusébio, Alonso, Pedro, Abdulla, Salim, Salim, Nahya, Juma, Omar, Shomari, Mwanajaa, Shubis, Kafuruki, Machera, Francisca, Hamad, Ali Said, Minja, Rose, Mtoro, Ali, Sykes, Alma, Ahmed, Saumu, Urassa, Alwisa Martin, Ali, Ali Mohammed, Mwangoka, Grace, Tanner, Marcel, Tinto, Halidou, D'Alessandro, Umberto, Sorgho, Hermann, Valea, Innocent, Tahita, Marc Christian, Kaboré, William, Ouédraogo, Sayouba, Sandrine, Yara, Guiguemdé, Robert Tinga, Ouédraogo, Jean Bosco, Hamel, Mary J, Lusingu, John, and Theander, Thor

Abstract

An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries.

Published
2011

7. Randomized, controlled trial of the long term safety, immunogenicity and efficacy of RTS,S/ AS02D malaria vaccine in infants living in a malaria-endemic region.

Author

Abdulla, Salim, Salim, Nahya, Machera, Francisca, Kamata, Richard, Juma, Omar, Shomari, Mwanajaa, Kubhoja, Sulende, Mohammed, Ali, Mwangoka, Grace, Aebi, Thomas, Mshinda, Hassan, Schellenberg, David, Carter, Terrell, Villafana, Tonya, Dubois, Marie-Claude, Leach, Amanda, Lievens, Marc, Vekemans, Johan, Cohen, Joe, and Ballou, W. Ripley

Subjects
IMMUNIZATION, RANDOMIZED controlled trials, DIPHTHERIA, HEPATITIS B vaccines
Abstract

Background: The RTS,S/AS malaria candidate vaccine is being developed with the intent to be delivered, if approved, through the Expanded Programme on Immunization (EPI) of the World Health Organization. Safety, immunogenicity and efficacy of the RTS,S/AS02D vaccine candidate when integrated into a standard EPI schedule for infants have been reported over a nine-month surveillance period. This paper describes results following 20 months of follow up. Methods: This Phase IIb, single-centre, randomized controlled trial enrolled 340 infants in Tanzania to receive three doses of RTS,S/AS02D or hepatitis B vaccine at 8, 12, and 16 weeks of age. All infants also received DTPw/Hib (diphtheria and tetanus toxoids, whole-cell pertussis vaccine, conjugated Haemophilus influenzae type b vaccine) at the same timepoints. The study was double-blinded to month 9 and single-blinded from months 9 to 20. Results: From month 0 to 20, at least one SAE was reported in 57/170 infants who received RTS,S/AS02D (33.5%; 95% confidence interval [CI]: 26.5, 41.2) and 62/170 infants who received hepatitis B vaccine (36.5%; 95% CI: 29.2, 44.2). The SAE profile was similar in both vaccine groups; none were considered to be related to vaccination. At month 20, 18 months after completion of vaccination, 71.8% of recipients of RTS,S/AS02D and 3.8% of recipients of hepatitis B vaccine had seropositive titres for anti-CS antibodies; seroprotective levels of anti-HBs antibodies remained in 100% of recipients of RTS,S/AS02D and 97.7% recipients of hepatitis B vaccine. Anti-HBs antibody GMTs were higher in the RTS,S/AS02D group at all post-vaccination time points compared to control. According to protocol population, vaccine efficacy against multiple episodes of malaria disease was 50.7% (95% CI: -6.5 to 77.1, p = 0.072) and 26.7% (95% CI: -33.1 to 59.6, p = 0.307) over 12 and 18 months post vaccination, respectively. In the Intention to Treat population, over the 20-month follow up, vaccine efficacy against multiple episodes of malaria disease was 14.4% (95% CI: -41.9 to 48.4, p = 0.545). (Continued on next page) (Continued from previous page) Conclusions: The acceptable safety profile and good tolerability of RTS,S/AS02D in combination with EPI vaccines previously reported from month 0 to 9 was confirmed over a 20 month surveillance period in this infant population. Antibodies against both CS and HBsAg in the RTS,S/AS02D group remained significantly higher compared to control for the study duration. Over 18 months follow up, RTS,S/AS02D prevented approximately a quarter of malaria cases in the study population. [ABSTRACT FROM AUTHOR]

Published
2013
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8. First results of phase 3 trial of RTS,S/AS01 malaria vaccine in African children.

Author

Agnandji ST, Lell B, Soulanoudjingar SS, Fernandes JF, Abossolo BP, Conzelmann C, Methogo BG, Doucka Y, Flamen A, Mordmüller B, Issifou S, Kremsner PG, Sacarlal J, Aide P, Lanaspa M, Aponte JJ, Nhamuave A, Quelhas D, Bassat Q, Mandjate S, Macete E, Alonso P, Abdulla S, Salim N, Juma O, Shomari M, Shubis K, Machera F, Hamad AS, Minja R, Mtoro A, Sykes A, Ahmed S, Urassa AM, Ali AM, Mwangoka G, Tanner M, Tinto H, D'Alessandro U, Sorgho H, Valea I, Tahita MC, Kaboré W, Ouédraogo S, Sandrine Y, Guiguemdé RT, Ouédraogo JB, Hamel MJ, Kariuki S, Odero C, Oneko M, Otieno K, Awino N, Omoto J, Williamson J, Muturi-Kioi V, Laserson KF, Slutsker L, Otieno W, Otieno L, Nekoye O, Gondi S, Otieno A, Ogutu B, Wasuna R, Owira V, Jones D, Onyango AA, Njuguna P, Chilengi R, Akoo P, Kerubo C, Gitaka J, Maingi C, Lang T, Olotu A, Tsofa B, Bejon P, Peshu N, Marsh K, Owusu-Agyei S, Asante KP, Osei-Kwakye K, Boahen O, Ayamba S, Kayan K, Owusu-Ofori R, Dosoo D, Asante I, Adjei G, Adjei G, Chandramohan D, Greenwood B, Lusingu J, Gesase S, Malabeja A, Abdul O, Kilavo H, Mahende C, Liheluka E, Lemnge M, Theander T, Drakeley C, Ansong D, Agbenyega T, Adjei S, Boateng HO, Rettig T, Bawa J, Sylverken J, Sambian D, Agyekum A, Owusu L, Martinson F, Hoffman I, Mvalo T, Kamthunzi P, Nkomo R, Msika A, Jumbe A, Chome N, Nyakuipa D, Chintedza J, Ballou WR, Bruls M, Cohen J, Guerra Y, Jongert E, Lapierre D, Leach A, Lievens M, Ofori-Anyinam O, Vekemans J, Carter T, Leboulleux D, Loucq C, Radford A, Savarese B, Schellenberg D, Sillman M, and Vansadia P

Subjects
Africa, Age Factors, Double-Blind Method, Female, Follow-Up Studies, Humans, Incidence, Infant, Intention to Treat Analysis, Malaria, Falciparum epidemiology, Malaria, Falciparum parasitology, Male, Meningitis epidemiology, Meningitis etiology, Parasite Load, Seizures epidemiology, Seizures etiology, Treatment Outcome, Malaria Vaccines adverse effects, Malaria Vaccines immunology, Malaria, Falciparum prevention & control, Plasmodium falciparum immunology, Plasmodium falciparum isolation & purification
Abstract

Background: An ongoing phase 3 study of the efficacy, safety, and immunogenicity of candidate malaria vaccine RTS,S/AS01 is being conducted in seven African countries., Methods: From March 2009 through January 2011, we enrolled 15,460 children in two age categories--6 to 12 weeks of age and 5 to 17 months of age--for vaccination with either RTS,S/AS01 or a non-malaria comparator vaccine. The primary end point of the analysis was vaccine efficacy against clinical malaria during the 12 months after vaccination in the first 6000 children 5 to 17 months of age at enrollment who received all three doses of vaccine according to protocol. After 250 children had an episode of severe malaria, we evaluated vaccine efficacy against severe malaria in both age categories., Results: In the 14 months after the first dose of vaccine, the incidence of first episodes of clinical malaria in the first 6000 children in the older age category was 0.32 episodes per person-year in the RTS,S/AS01 group and 0.55 episodes per person-year in the control group, for an efficacy of 50.4% (95% confidence interval [CI], 45.8 to 54.6) in the intention-to-treat population and 55.8% (97.5% CI, 50.6 to 60.4) in the per-protocol population. Vaccine efficacy against severe malaria was 45.1% (95% CI, 23.8 to 60.5) in the intention-to-treat population and 47.3% (95% CI, 22.4 to 64.2) in the per-protocol population. Vaccine efficacy against severe malaria in the combined age categories was 34.8% (95% CI, 16.2 to 49.2) in the per-protocol population during an average follow-up of 11 months. Serious adverse events occurred with a similar frequency in the two study groups. Among children in the older age category, the rate of generalized convulsive seizures after RTS,S/AS01 vaccination was 1.04 per 1000 doses (95% CI, 0.62 to 1.64)., Conclusions: The RTS,S/AS01 vaccine provided protection against both clinical and severe malaria in African children. (Funded by GlaxoSmithKline Biologicals and the PATH Malaria Vaccine Initiative; RTS,S ClinicalTrials.gov number, NCT00866619 .).

Published
2011
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