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201. Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

Author

Frenck, Robert W., primary, Gurtman, Alejandra, additional, Rubino, John, additional, Smith, William, additional, van Cleeff, Martin, additional, Jayawardene, Deepthi, additional, Giardina, Peter C., additional, Emini, Emilio A., additional, Gruber, William C., additional, Scott, Daniel A., additional, and Schmöle-Thoma, Beate, additional

Published
2012
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202. 13-valent Pneumococcal Conjugate Vaccine Given With Meningococcal C–Tetanus Toxoid Conjugate and Other Routine Pediatric Vaccinations

Author

Martinón-Torres, Federico, primary, Gimenez-Sanchez, Francisco, additional, Gurtman, Alejandra, additional, Bernaola, Enrique, additional, Diez-Domingo, Javier, additional, Carmona, Alfonso, additional, Sidhu, Mohinder, additional, Sarkozy, Denise A., additional, Gruber, William C., additional, Emini, Emilio A., additional, and Scott, Daniel A., additional

Published
2012
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204. Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine in Children Previously Immunized With 7-valent Pneumococcal Conjugate Vaccine

Author

Frenck, Robert, primary, Thompson, Allison, additional, Yeh, Sylvia H., additional, London, Arnold, additional, Sidhu, Mohinder S., additional, Patterson, Scott, additional, Gruber, William C., additional, Emini, Emilio A., additional, Scott, Daniel A., additional, and Gurtman, Alejandra, additional

Published
2011
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205. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine

Author

Gimenez-Sanchez, Francisco, primary, Kieninger, Dorothee M., additional, Kueper, Kathrin, additional, Martinon-Torres, Federico, additional, Bernaola, Enrique, additional, Diez-Domingo, Javier, additional, Steul, Kathrin, additional, Juergens, Christine, additional, Gurtman, Alejandra, additional, Giardina, Peter, additional, Liang, John Z., additional, Gruber, William C., additional, Emini, Emilio A., additional, and Scott, Daniel A., additional

Published
2011
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208. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine

Author

Gadzinowski, Janusz, primary, Albrecht, Piotr, additional, Hasiec, Barbara, additional, Konior, Ryszard, additional, Dziduch, Jerzy, additional, Witor, Anita, additional, Mellelieu, Tracey, additional, Tansey, Susan P., additional, Jones, Thomas, additional, Sarkozy, Denise, additional, Emini, Emilio A., additional, Gruber, William C., additional, and Scott, Daniel A., additional

Published
2011
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210. Immunogenicity and Reactogenicity of a 13-Valent-pneumococcal Conjugate Vaccine Administered at 2, 4, and 12 Months of Age

Author

Snape, Matthew D., primary, Klinger, Chaam L., additional, Daniels, Elvis D., additional, John, Tessa M., additional, Layton, Helen, additional, Rollinson, Llinos, additional, Pestridge, Sarah, additional, Dymond, Sandra, additional, Galiza, Eva, additional, Tansey, Susan, additional, Scott, Daniel A., additional, Baker, Sherryl A., additional, Jones, Thomas R., additional, Yu, Ly-Mee, additional, Gruber, William C., additional, Emini, Emilio A., additional, Faust, Saul N., additional, Finn, Adam, additional, Heath, Paul T., additional, and Pollard, Andrew J., additional

Published
2010
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211. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany

Author

Kieninger, Dorothee M., primary, Kueper, Kathrin, additional, Steul, Katrin, additional, Juergens, Christine, additional, Ahlers, Norbert, additional, Baker, Sherryl, additional, Jansen, Kathrin U., additional, Devlin, Carmel, additional, Gruber, William C., additional, Emini, Emilio A., additional, and Scott, Daniel A., additional

Published
2010
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212. Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers

Author

Esposito, Susanna, primary, Tansey, Susan, additional, Thompson, Allison, additional, Razmpour, Ahmad, additional, Liang, John, additional, Jones, Thomas R., additional, Ferrera, Giuseppe, additional, Maida, Alessandro, additional, Bona, Gianni, additional, Sabatini, Caterina, additional, Pugni, Lorenza, additional, Emini, Emilio A., additional, Gruber, William C., additional, Scott, Daniel A., additional, and Principi, Nicola, additional

Published
2010
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213. Influenza vaccine concurrently administered with a combination measles, mumps, and rubella vaccine to young children

Author

Lum, Lucy Chai See, primary, Borja-Tabora, Charissa Fay, additional, Breiman, Robert F., additional, Vesikari, Timo, additional, Sablan, Benjamin P., additional, Chay, Oh Moh, additional, Tantracheewathorn, Taweewong, additional, Schmitt, Heinz-Josef, additional, Lau, Yu-Lung, additional, Bowonkiratikachorn, Piyaporn, additional, Tam, John S., additional, Lee, Bee Wah, additional, Tan, Kah Kee, additional, Pejcz, Jerzy, additional, Cha, Sungho, additional, Gutierrez-Brito, Maricruz, additional, Kaltenis, Petras, additional, Vertruyen, Andre, additional, Czajka, Hanna, additional, Bojarskas, Jurgis, additional, Brooks, W. Abdullah, additional, Cheng, Sheau-Mei, additional, Rappaport, Ruth, additional, Baker, Sherryl, additional, Gruber, William C., additional, and Forrest, Bruce D., additional

Published
2010
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215. A multinational, randomized, placebo-controlled trial to assess the immunogenicity, safety, and tolerability of live attenuated influenza vaccine coadministered with oral poliovirus vaccine in healthy young children

Author

Breiman, Robert F., primary, Brooks, W. Abdullah, additional, Goswami, Doli, additional, Lagos, Rosanna, additional, Borja-Tabora, Charissa, additional, Lanata, Claudio F., additional, Londoño, Jaime A. Cèspedes, additional, Lum, Lucy Chai See, additional, Rappaport, Ruth, additional, Razmpour, Ahmad, additional, Walker, Robert E., additional, Gruber, William C., additional, and Forrest, Bruce D., additional

Published
2009
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219. Efficacy and Safety of a Live Attenuated, Cold-Adapted Influenza Vaccine, Trivalent Against Culture-Confirmed Influenza in Young Children in Asia

Author

Tam, John S., primary, Capeding, Maria Rosario Z., additional, Lum, Lucy Chai See, additional, Chotpitayasunondh, Tawee, additional, Jiang, Zaifang, additional, Huang, Li-Min, additional, Lee, Bee Wah, additional, Qian, Yuan, additional, Samakoses, Rudiwilai, additional, Lolekha, Somsak, additional, Rajamohanan, K Pillai, additional, Narayanan, S Noel, additional, Kirubakaran, Chellam, additional, Rappaport, Ruth, additional, Razmpour, Ahmad, additional, Gruber, William C., additional, and Forrest, Bruce D., additional

Published
2007
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222. Immunogenicity, Safety, and Tolerability of 13-Valent Pneumococcal Conjugate Vaccine Followed by 23-Valent Pneumococcal Polysaccharide Vaccine in Recipients of Allogeneic Hematopoietic Stem Cell Transplant Aged =2 Years: An Open-Label Study.

Author

Cordonnier, Catherine, Ljungman, Per, Juergens, Christine, Maertens, Johan, Selleslag, Dominik, Sundaraiyer, Vani, Giardina, Peter C., Clarke, Keri, Gruber, William C., Scott, Daniel A., and Schmoele-Thoma, Beate

Subjects
PNEUMOCOCCAL vaccines, HEMATOPOIETIC stem cell transplantation, PNEUMONIA prevention, HOMOGRAFTS, IMMUNOGLOBULIN G, STREPTOCOCCUS pneumoniae, COMPLICATIONS from organ transplantation, VACCINATION complications, PATIENTS, VACCINES
Abstract

Background. Life-threatening Streptococcus pneumoniae infections often occur after hematopoietic stem cell transplant (HSCT); vaccination is important for prevention. Methods. In an open-label study, patients (n = 251) 3-6 months after allogeneic HSCT received 3 doses of 13-valent pneumococcal conjugate vaccine (PCV13) at 1-month intervals, a fourth dose 6 months later, and 1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) 1 month later. Immunogenicity at prespecified time points and vaccine safety were assessed. Results. In the evaluable immunogenicity population (N = 216; mean age, 37.8 years), geometric mean fold rises (GMFRs) of immunoglobulin G geometric mean concentrations from baseline to postdose 3 showed significant increases in antibody levels across all PCV13 serotypes (GMFR range, 2.99-23.85; 95% confidence interval lower limit, >1); there were significant declines over the next 6 months, significant increases from predose 4 to postdose 4 (GMFR range, 3.00-6.97), and little change after PPSV23 (GMFR range, 0.86-1.12). Local and systemic reactions were more frequent after dose 4. Six patients experienced serious adverse events possibly related to PCV13 (facial diplegia, injection-site erythema and pyrexia, autoimmune hemolytic anemia, and suspected lack of vaccine efficacy after dose 3 leading to pneumococcal infection), PCV13 and PPSV23 (Guillain-Barré syndrome), or PPSV23 (cellulitis). There were 14 deaths, none related to study vaccines. Conclusions. A 3-dose PCV13 regimen followed by a booster dose may be required to protect against pneumococcal disease in HSCT recipients. Dose 4 was associated with increased local and systemic reactions, but the overall safety profile of a 4-dose regimen was considered acceptable. [ABSTRACT FROM AUTHOR]

Published
2015
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223. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIVInfected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine.

Author

Glesby, Marshall J., Watson, Wendy, Brinson, Cynthia, Greenberg, Richard N., Lalezari, Jacob P., Skiest, Daniel, Sundaraiyer, Vani, Natuk, Robert, Gurtman, Alejandra, Scott, Daniel A., Emini, Emilio A., Gruber, William C., and Schmoele-Thoma, Beate

Subjects
STREPTOCOCCUS pneumoniae, PNEUMOCOCCAL vaccines, VACCINE safety, POLYSACCHARIDES, HIV infections, IMMUNOGLOBULIN G, VACCINATION, THERAPEUTICS
Abstract

Background. Persons with human immunodeficiency virus (HIV) infection are at increased risk of pneumococcal disease. We evaluated the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine (PCV13) in this population. Methods. HIV-infected persons ≥18 years of age who were previously vaccinated with ≥1 dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) and had CD4 cell counts ≥200 cells/mm3 and HIV viral loads <50 000 copies/mL were enrolled in this 3-dose PCV13 open-label study. Results. A total of 329 subjects received ≥1 dose, and 279 received 3 doses administered at 6-month intervals. Increases in anticapsular polysaccharide immunoglobulin G concentrations and opsonophagocytic antibody titers were demonstrated 1 month after each of the 3 doses of PCV13. Antibody levels were generally similar after each dose. The responses were similar whether subjects had previously received 1 or ≥2 doses of PPSV23. Pain at the injection-site was the most common local reaction. Severe injection site or systemic events were uncommon. Conclusions. Vaccination with PCV13 induces anticapsular immunoglobulin G and opsonophagocytic antibody responses in HIV-infected adults with prior PPSV23 vaccination and CD4 cell counts ≥200 cells/mm3. The observations support the use of PCV13 in this population. [ABSTRACT FROM AUTHOR]

Published
2015
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224. Multicenter Surveillance of Streptococcus pneumoniae Isolates From Middle Ear and Mastoid Cultures in the 13-Valent Pneumococcal Conjugate Vaccine Era.

Author

Kaplan, Sheldon L., Center, Kimberly J., Barson, William J., Ling-Lin, Philana, Romero, José R., Bradley, John S., Tan, Tina Q., Hoffman, Jill A., Peters, Timothy R., Gurtman, Alejandra, Scott, Daniel A., Trammel, James, Gruber, William C., Hulten, Kristina G., and Mason, Edward O.

Subjects
OTITIS media in children, COMBINED vaccines, STREPTOCOCCUS pneumoniae, MIDDLE ear, MASTOIDITIS, SEROTYPES
Abstract

Background. Streptococcus pneumoniae is a common cause of otitis media (OM) in children; mastoiditis remains an important complication of OM. Limited data are available on the impact of the 13-valent pneumococcal conjugate vaccine (PCV13) on pneumococcal otitis. Methods. Investigators from 8 children's hospitals in the United States prospectively collected pneumococcal isolates from middle ear or mastoid cultures from children from 2011 to 2013. Serotype and antibiotic susceptibilities were determined and PCV13 doses for children documented. Results. Over the 3-year period, the proportion of isolates included in PCV13 ( plus a related serotype) decreased significantly (P = .0006) among the middle ear/mastoid isolates (2011, 50% [74/149]; 2012, 40.5% [47/116]; 2013, 29% [34/118]). The number of serotype 19A isolates in 2013 (n = 12, 10.2% of total) decreased 76% compared with the number of 19A isolates in 2011 (n = 50, 33.6% of total). Of the children from whom serotype 19A was isolated (n = 93), 55% had previously received <3 doses of PCV13. The most common non-PCV13 serotypes for the combined years were 35B (n = 37), 21 (n = 20), 23B (n = 20), 15B (n = 18), 11 (n = 17), 23A (n = 14), 15A (n = 14), and 15C (n = 14). The proportion of isolates with a penicillin minimal inhibitory concentration >2 μg/mL decreased significantly over the 3 years (2011, 22% [35/154]; 2012, 20% [24/118]; 2013, 10% [12/120]; P < .02). Conclusions. The number of pneumococcal isolates and the percentage of isolates with high-level penicillin resistance from cultures taken from children with OM or mastoiditis for clinical indications have decreased following PCV13 use, largely related to decreases in serotype 19A isolates. [ABSTRACT FROM AUTHOR]

Published
2015
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225. Superior Relative Efficacy of Live Attenuated Influenza Vaccine Compared With Inactivated Influenza Vaccine in Young Children With Recurrent Respiratory Tract Infections

Author

Ashkenazi, Shai, primary, Vertruyen, Andre, additional, Ar??stegui, Javier, additional, Esposito, Susanna, additional, McKeith, David Douglas, additional, Klemola, Timo, additional, Biolek, Jiri, additional, K??hr, Joachim, additional, Bujnowski, Tadeusz, additional, Desgrandchamps, Daniel, additional, Cheng, Sheau-Mei, additional, Skinner, Jonathan, additional, Gruber, William C., additional, and Forrest, Bruce D., additional

Published
2006
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226. Comparison of the Efficacy and Safety of Live Attenuated Cold-Adapted Influenza Vaccine, Trivalent, With Trivalent Inactivated Influenza Virus Vaccine in Children and Adolescents With Asthma

Author

Fleming, Douglas M., primary, Crovari, Pietro, additional, Wahn, Ulrich, additional, Klemola, Timo, additional, Schlesinger, Yechiel, additional, Langussis, Alexangros, additional, ??ymar, Knut, additional, Garcia, Maria Luz, additional, Krygier, Alain, additional, Costa, Herculano, additional, Heininger, Ulrich, additional, Pregaldien, Jean-Louis, additional, Cheng, Sheau-Mei, additional, Skinner, Jonathan, additional, Razmpour, Ahmad, additional, Saville, Melanie, additional, Gruber, William C., additional, and Forrest, Bruce, additional

Published
2006
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227. Transmissibility, infectivity and immunogenicity of a live human parainfluenza type 3 virus vaccine (HPIV3cp45) among susceptible infants and toddlers

Author

Madhi, Shabir A., primary, Cutland, Clare, additional, Zhu, Yuwei, additional, Hackell, Jill G., additional, Newman, Frances, additional, Blackburn, Nigel, additional, Murphy, Brian R., additional, Belshe, Robert B., additional, Karron, Ruth A., additional, Deatly, Anne M., additional, Gruber, William C., additional, Bernstein, David I., additional, and Wright, Peter F., additional

Published
2006
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230. Correlates of Immune Protection Induced by Live, Attenuated, Cold‐Adapted, Trivalent, Intranasal Influenza Virus Vaccine

Author

Belshe, Robert B., primary, Gruber, William C., additional, Mendelman, Paul M., additional, Mehta, Harshvardhan B., additional, Mahmood, Kutubuddin, additional, Reisinger, Keith, additional, Treanor, John, additional, Zangwill, Ken, additional, Hayden, Frederick G., additional, Bernstein, David I., additional, Kotloff, Karen, additional, King, James, additional, Piedra, Pedro A., additional, Block, Stan L., additional, Yan, Lihan, additional, and Wolff, Mark, additional

Published
2000
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231. Efficacy of vaccination with live attenuated, cold-adapted, trivalent, intranasal influenza virus vaccine against a variant (A/Sydney) not contained in the vaccine

Author

Belshe, Robert B., primary, Gruber, William C., additional, Mendelman, Paul M., additional, Cho, Iksung, additional, Reisinger, Keith, additional, Block, Stan L., additional, Wittes, Janet, additional, Iacuzio, Dominick, additional, Piedra, Pedro, additional, Treanor, John, additional, King, James, additional, Kotloff, Karen, additional, Bernstein, David I., additional, Hayden, Frederick G., additional, Zangwill, Ken, additional, Yan, Lihan, additional, and Wolff, Mark, additional

Published
2000
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232. Enzyme-linked immunosorbent assay to assess respiratory syncytial virus concentration and correlate results with inflammatory mediators in tracheal secretions

Author

MALLEY, RICHARD, primary, VERNACCHIO, LOUIS, additional, DEVINCENZO, JOHN, additional, RAMILO, OCTAVIO, additional, DENNEHY, PENELOPE H., additional, MEISSNER, H. CODY, additional, GRUBER, WILLIAM C., additional, JAFRI, HASAN S., additional, SANCHEZ, PABLO J., additional, MACDONALD, KRISTIN, additional, MONTANA, JOHN B., additional, THOMPSON, CLAUDETTE M., additional, and AMBROSINO, DONNA M., additional

Published
2000
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236. Reduction of Respiratory Syncytial Virus (RSV) in Tracheal Aspirates in Intubated Infants by Use of Humanized Monoclonal Antibody to RSV F Protein

Author

Malley, Richard, primary, DeVincenzo, John, additional, Ramilo, Octavio, additional, Dennehy, Penelope H., additional, Meissner, H. Cody, additional, Gruber, William C., additional, Sanchez, Pablo J., additional, Jafri, Hasan, additional, Balsley, James, additional, Carlin, David, additional, Buckingham, Steve, additional, Vernacchio, Louis, additional, and Ambrosino, Donna M., additional

Published
1998
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237. Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Children 6–17 Years of Age in India

Author

Agarkhedkar, Sharad, Juergens, Christine, Balasundaram, Krishnamurthy, Agarkhedkar, Shalaka, Sundaraiyer, Vani, Le Dren-Narayanin, Natacha, Cutler, Mark W., Gruber, William C., Scott, Daniel A., and Schmoele-Thoma, Beate

Abstract

Supplemental Digital Content is available in the text.In an open-label study in India, 200 healthy participants 6–17 years of age received 13-valent pneumococcal conjugate vaccine (PCV13). PCV13 elicited robust functional antibody immune responses. No adverse events were reported by caregivers at the 1-month follow-up visit. The immunogenicity results together with the known favorable risk–benefit profile of PCV13 support extension of the indication to this age group in India.

Published
2017
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238. The Efficacy of Live Attenuated, Cold-Adapted, Trivalent, Intranasal Influenzavirus Vaccine in Children

Author

Belshe, Robert B., primary, Mendelman, Paul M., additional, Treanor, John, additional, King, James, additional, Gruber, William C., additional, Piedra, Pedro, additional, Bernstein, David I., additional, Hayden, Frederick G., additional, Kotloff, Karen, additional, Zangwill, Ken, additional, Iacuzio, Dominick, additional, and Wolff, Mark, additional

Published
1998
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239. Viral Concentration in Upper and Lower Respiratory Secretions from Respiratory Syncytial Virus (RSV) Infected Children Treated with RSV Monoclonal Antibody (MEDI-493) † 830

Author

DeVincenzo, John P, primary, Malley, Richard, additional, Ramilo, Octavio, additional, Dennehy, Penelope H, additional, Meissner, H Cody, additional, Gruber, William C, additional, Sanchez, Pablo J, additional, Jafri, Hasan, additional, Balsley, James, additional, Carlin, David, additional, Buckingham, Steve, additional, Vernacchio, Louis, additional, and Ambrosino, Donna, additional

Published
1998
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247. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination

Author

Bhorat, As’ad E., Madhi, Shabir A., Laudat, France, Sundaraiyer, Vani, Gurtman, Alejandra, Jansen, Kathrin U., Scott, Daniel A., Emini, Emilio A., Gruber, William C., and Schmoele-Thoma, Beate

Abstract

Immunocompromised individuals are at an increased risk of pneumococcal disease. Vaccination is recommended as an important strategy to reduce risk of pneumococcal disease in HIV-infected individuals. This study evaluated the safety and immunogenicity of three 13-valent pneumococcal conjugate vaccine (PCV13) doses followed by one dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at 1-month intervals in pneumococcal vaccine-naive, HIV-infected individuals.

Published
2015
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249. Open-Label Trial of Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Adults =50 Years of Age in Mexico

Author

Tinoco, Juan Carlos, Juergens, Christine, Ruiz Palacios, Guillermo M., Vazquez-Narvaez, Jorge, Enkerlin-Pauwells, Hermann Leo, Sundaraiyer, Vani, Pathirana, Sudam, Kalinina, Elena, Gruber, William C., Scott, Daniel A., and Schmoele-Thoma, Beate

Abstract

ABSTRACTThis open-label multicenter clinical trial conducted in Mexico assessed the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) in adults =50 years of age not previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine (PPSV23). The PCV13 elicited a robust immune response in this study population, as reflected by the magnitude of fold rises in functional antibody levels measured by serotype-specific opsonophagocytic activity (OPA) assays before and 1 month after vaccination. Although the prevaccination OPA geometric mean titers (GMTs) for the majority of the serotypes were significantly lower in the 50- to 64-year age group than those in the =65-year age group, the postvaccination immune responses were generally similar. The overall immune responses were higher for the majority of the serotypes in the Mexican study population than those in similar adult study populations who received the PCV13 in Europe and the United States. PCV13 was well tolerated, and there were no vaccine-related serious adverse events. In conclusion, PCV13 is safe and immunogenic when administered to adults =50 years of age in Mexico and has the potential to protect against vaccine-type pneumococcal disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT01432262.)

Published
2014
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