Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel

Keith S. Reisinger, Stan L. Block, Michelle Collins-Ogle, Colin Marchant, Melissa Catlett, David Radley, Heather L. Sings, Richard M. Haupt, Elizabeth I.O. Garner

Research output: Contribution to journalArticle

42 Citations (Scopus)

Abstract

OBJECTIVES: Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel. METHODS: In this open-label study, boys (n=394) and girls (n=648) aged 10 to 17 were randomly assigned in a 1:1 ratio as follows: group A (concomitant administration) received a 0.5-mL dose of Gardasil at day 1, month 2, and month 6 and a 0.5-mL dose of Menactra and Adacel on day 1; group B (nonconcomitant administration) received Gardasil at day 1, month 2, and month 6 and Menactra and Adacel at month 1. Antibody levels for all vaccine components were measured. Systemic, injection-site, and serious adverse experiences (AEs) were monitored. RESULTS: Immune responses after concomitant administration of the 3 vaccines were noninferior to nonconcomitant administration. Sero-conversion for Gardasil was ≥99% in both groups A and B. For Menactra and Adacel, concomitant administration of the vaccines was demonstrated to be noninferior to nonconcomitant administration. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator. CONCLUSIONS: Overall, concomitant administration was generally well-tolerated and did not interfere with the immune response to the respective vaccines. Concomitant administration should minimize the number of visits required to deliver each vaccine individually, leading to increased compliance and more effective disease prevention.

Original languageEnglish (US)
Pages (from-to)1142-1151
Number of pages10
JournalPediatrics
Volume125
Issue number6
DOIs
StatePublished - Jun 1 2010
Externally publishedYes

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Meningococcal Vaccines
Vaccines
Safety
Papillomavirus Vaccines
Injections
Muscle Weakness
adacel
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
Compliance
Research Personnel
Antibodies

Keywords

  • Adacel
  • Concomitant
  • Gardasil
  • HPV vaccine
  • Menactra

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Reisinger, K. S., Block, S. L., Collins-Ogle, M., Marchant, C., Catlett, M., Radley, D., ... Garner, E. I. O. (2010). Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. Pediatrics, 125(6), 1142-1151. https://doi.org/10.1542/peds.2009-2336

Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. / Reisinger, Keith S.; Block, Stan L.; Collins-Ogle, Michelle; Marchant, Colin; Catlett, Melissa; Radley, David; Sings, Heather L.; Haupt, Richard M.; Garner, Elizabeth I.O.

In: Pediatrics, Vol. 125, No. 6, 01.06.2010, p. 1142-1151.

Research output: Contribution to journalArticle

Reisinger, KS, Block, SL, Collins-Ogle, M, Marchant, C, Catlett, M, Radley, D, Sings, HL, Haupt, RM & Garner, EIO 2010, 'Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel', Pediatrics, vol. 125, no. 6, pp. 1142-1151. https://doi.org/10.1542/peds.2009-2336
Reisinger, Keith S. ; Block, Stan L. ; Collins-Ogle, Michelle ; Marchant, Colin ; Catlett, Melissa ; Radley, David ; Sings, Heather L. ; Haupt, Richard M. ; Garner, Elizabeth I.O. / Safety, tolerability, and immunogenicity of gardasil given concomitantly with Menactra and Adacel. In: Pediatrics. 2010 ; Vol. 125, No. 6. pp. 1142-1151.
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abstract = "OBJECTIVES: Multinational phase III trials of a human papillomavirus vaccine, Gardasil, have shown the vaccine to be generally well-tolerated, efficacious, and immunogenic. We evaluated the immunogenicity and safety of Gardasil administered concomitantly with Menactra and Adacel. METHODS: In this open-label study, boys (n=394) and girls (n=648) aged 10 to 17 were randomly assigned in a 1:1 ratio as follows: group A (concomitant administration) received a 0.5-mL dose of Gardasil at day 1, month 2, and month 6 and a 0.5-mL dose of Menactra and Adacel on day 1; group B (nonconcomitant administration) received Gardasil at day 1, month 2, and month 6 and Menactra and Adacel at month 1. Antibody levels for all vaccine components were measured. Systemic, injection-site, and serious adverse experiences (AEs) were monitored. RESULTS: Immune responses after concomitant administration of the 3 vaccines were noninferior to nonconcomitant administration. Sero-conversion for Gardasil was ≥99{\%} in both groups A and B. For Menactra and Adacel, concomitant administration of the vaccines was demonstrated to be noninferior to nonconcomitant administration. Concomitant administration was generally well-tolerated. No participants withdrew because of an AE. One serious AE of transient muscular weakness of <24 hours' duration after the third Gardasil injection was reported in group B and was deemed possibly vaccine-related by the investigator. CONCLUSIONS: Overall, concomitant administration was generally well-tolerated and did not interfere with the immune response to the respective vaccines. Concomitant administration should minimize the number of visits required to deliver each vaccine individually, leading to increased compliance and more effective disease prevention.",
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AU - Marchant, Colin

AU - Catlett, Melissa

AU - Radley, David

AU - Sings, Heather L.

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AU - Garner, Elizabeth I.O.

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