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

Research output: Contribution to journalArticle

30 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)e563-572
JournalPediatrics
Volume136
Issue number3
DOIs
StatePublished - Sep 1 2015

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Meningococcal Vaccines
Papillomavirus Vaccines
Vaccines
Injections
Diphtheria
Whooping Cough
Tetanus
Gammapapillomavirus
Antigens
Neisseria meningitidis
Antibodies
Antibody Formation
Vaccination
Age Groups
Safety

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Schilling, A., Parra, M. M., Gutierrez, M., Restrepo, J., Ucros, S., Herrera, T., ... Meulen, A. S. T. (2015). Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and tdap vaccines. Pediatrics, 136(3), e563-572. https://doi.org/10.1542/peds.2014-4199

Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and tdap vaccines. / Schilling, Andrea; Parra, Mercedes Macias; Gutierrez, Maricruz; Restrepo, Jaime; Ucros, Santiago; Herrera, Teobaldo; Engel, Eli; Huicho, Luis; Shew, Marcia; Maansson, Roger; Caldwell, Nicole; Luxembourg, Alain; Meulen, Ajoke Sobanjo Ter.

In: Pediatrics, Vol. 136, No. 3, 01.09.2015, p. e563-572.

Research output: Contribution to journalArticle

Schilling, A, Parra, MM, Gutierrez, M, Restrepo, J, Ucros, S, Herrera, T, Engel, E, Huicho, L, Shew, M, Maansson, R, Caldwell, N, Luxembourg, A & Meulen, AST 2015, 'Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and tdap vaccines', Pediatrics, vol. 136, no. 3, pp. e563-572. https://doi.org/10.1542/peds.2014-4199
Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T et al. Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and tdap vaccines. Pediatrics. 2015 Sep 1;136(3):e563-572. https://doi.org/10.1542/peds.2014-4199
Schilling, Andrea ; Parra, Mercedes Macias ; Gutierrez, Maricruz ; Restrepo, Jaime ; Ucros, Santiago ; Herrera, Teobaldo ; Engel, Eli ; Huicho, Luis ; Shew, Marcia ; Maansson, Roger ; Caldwell, Nicole ; Luxembourg, Alain ; Meulen, Ajoke Sobanjo Ter. / Coadministration of a 9-valent human papillomavirus vaccine with meningococcal and tdap vaccines. In: Pediatrics. 2015 ; Vol. 136, No. 3. pp. e563-572.
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AU - Parra, Mercedes Macias

AU - Gutierrez, Maricruz

AU - Restrepo, Jaime

AU - Ucros, Santiago

AU - Herrera, Teobaldo

AU - Engel, Eli

AU - Huicho, Luis

AU - Shew, Marcia

AU - Maansson, Roger

AU - Caldwell, Nicole

AU - Luxembourg, Alain

AU - Meulen, Ajoke Sobanjo Ter

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AB - 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.

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