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American Academy of Pediatrics
Article

Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines

Andrea Schilling, Mercedes Macias Parra, Maricruz Gutierrez, Jaime Restrepo, Santiago Ucros, Teobaldo Herrera, Eli Engel, Luis Huicho, Marcia Shew, Roger Maansson, Nicole Caldwell, Alain Luxembourg and Ajoke Sobanjo ter Meulen
Pediatrics August 2015, peds.2014-4199; DOI: https://doi.org/10.1542/peds.2014-4199
Andrea Schilling
aFacultad de Medicina Clinica Alemana-Universidad del Desarrollo, Santiago, Chile;
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Mercedes Macias Parra
bInstituto Nacional de Pediatría, Mexico City, Mexico;
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Maricruz Gutierrez
cHospital del Niño Poblano, Puebla, Mexico;
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Jaime Restrepo
dFundacion Centro de Investigacion Clinica CIC, Medellín, Colombia;
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Santiago Ucros
eCentro de Investigaciones en Salud, Fundacion Santa Fe de Bogotá, Bogotá, Colombia;
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Teobaldo Herrera
fInsituto de Investigación Nutricional anexo Huáscar, Lima, Perú;
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Eli Engel
gBayview Research Group, Valley Village, California;
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Luis Huicho
hInstituto Nacional de Salud del Niño, Lima, Perú;
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Marcia Shew
iIndiana University School of Medicine/Department of Pediatrics, Indianapolis, Indiana; and
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Roger Maansson
jMerck & Co., Inc., Kenilworth, New Jersey
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Nicole Caldwell
jMerck & Co., Inc., Kenilworth, New Jersey
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Alain Luxembourg
jMerck & Co., Inc., Kenilworth, New Jersey
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Ajoke Sobanjo ter Meulen
jMerck & Co., Inc., Kenilworth, New Jersey
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Abstract

BACKGROUND: This study in 11- to 15-year-old boys and girls compared the immunogenicity and safety of GARDASIL 9 (9-valent human papillomavirus [9vHPV] vaccine) administered either concomitantly or nonconcomitantly with 2 vaccines routinely administered in this age group (Menactra [MCV4; Neisseria meningitidis serotypes A/C/Y/W-135] or Adacel [Tdap; diphtheria/tetanus/acellular pertussis]).

METHODS: Participants received 9vHPV vaccine at day 1 and months 2 and 6; the concomitant group (n = 621) received MCV4/Tdap concomitantly with 9vHPV vaccine at day 1; the nonconcomitant group (n = 620) received MCV4/Tdap at month 1. Antibodies to HPV-, MCV4-, and Tdap-relevant antigens were determined. Injection-site and systemic adverse events (AEs) were monitored for 15 days after any vaccination; serious AEs were monitored throughout the study.

RESULTS: The geometric mean titers for all HPV types in 9vHPV vaccine 4 weeks after dose 3, proportion of subjects with a fourfold rise or greater in titers for 4 N meningitidis serotypes 4 weeks after injection with MCV4, proportion of subjects with antibody titers to diphtheria and tetanus ≥0.1 IU/mL, and geometric mean titers for pertussis antigens 4 weeks after injection with Tdap were all noninferior in the concomitant group compared with the nonconcomitant group. Injection-site swelling occurred more frequently in the concomitant group. There were no vaccine-related serious AEs.

CONCLUSIONS: Concomitant administration of 9vHPV vaccine with MCV4/Tdap was generally well tolerated and did not interfere with the antibody response to any of these vaccines. This strategy would minimize the number of visits required to deliver each vaccine individually.

  • Accepted June 11, 2015.
  • Copyright © 2015 by the American Academy of Pediatrics

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Pediatrics
Vol. 147, Issue 3
1 Mar 2021
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Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines
Andrea Schilling, Mercedes Macias Parra, Maricruz Gutierrez, Jaime Restrepo, Santiago Ucros, Teobaldo Herrera, Eli Engel, Luis Huicho, Marcia Shew, Roger Maansson, Nicole Caldwell, Alain Luxembourg, Ajoke Sobanjo ter Meulen
Pediatrics Aug 2015, peds.2014-4199; DOI: 10.1542/peds.2014-4199

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Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines
Andrea Schilling, Mercedes Macias Parra, Maricruz Gutierrez, Jaime Restrepo, Santiago Ucros, Teobaldo Herrera, Eli Engel, Luis Huicho, Marcia Shew, Roger Maansson, Nicole Caldwell, Alain Luxembourg, Ajoke Sobanjo ter Meulen
Pediatrics Aug 2015, peds.2014-4199; DOI: 10.1542/peds.2014-4199
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