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Safety and Immunogenicity of a Booster Dose of the 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine Coadministered With Measles-Mumps-Rubella-Varicella Vaccine in Children Aged 12 to 16 Months

Vesikari, Timo MD*; Karvonen, Aino MD*; Lindblad, Niklas MD*; Korhonen, Tiina MD*; Lommel, Patricia BSc†; Willems, Paul MD†; Dieussaert, Ilse Ir†; Schuerman, Lode MD†

Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0b013e3181dffabf
Online-Only: Original Studies
Abstract

Background: A booster dose of pneumococcal conjugate vaccine may be administered at the same age as measles-mumps-rubella-varicella (MMRV) vaccination. This study examined the safety, reactogenicity, and immunogenicity of a booster dose of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with MMRV vaccine.

Methods: In this open, controlled study, 325 healthy children aged 12 to 14 months were randomized to 1 of 3 groups: the first group (N = 110) received PHiD-CV and MMRV vaccine followed 6 to 8 weeks later by MMRV and DTPa-HBV-IPV/Hib vaccines; the second group (N = 101) received DTPa-HBV-IPV/Hib and MMRV vaccines followed 6 to 8 weeks later by PHiD-CV and MMRV vaccine; the third group (N = 114) received PHiD-CV and DTPa-HBV-IPV/Hib vaccine during 1 vaccination visit. Immune responses were assessed with GlaxoSmithKline's 22F-inhibition enzyme-linked immunosorbent assay (for PHiD-CV), commercial enzyme-linked immunosorbent assay (for MMR), or indirect immunofluorescence assay (for varicella). Adverse events were recorded by the parents/guardians.

Results: After the first vaccination, 2 peaks in fever (rectal temperature ≥38°C) were observed; at days 0 to 2, related to PHiD-CV and DTPa-HBV-IPV/Hib vaccination, and at days 4 to 12, related to MMRV vaccination. Booster responses to pneumococcal antigens and protein D and seroconversion rates for all MMRV vaccine components were high.

Conclusions: PHiD-CV and MMRV vaccine can be coadministered without compromising the safety and immunogenicity profiles of either vaccine.

Author Information

From the *Vaccine Research Center, University of Tampere Medical School, Tampere, Finland; and †GlaxoSmithKline Biologicals, Wavre, Belgium.

Accepted for publication March 2, 2010.

This study (study number 107706; www.ClinicalTrials.gov: NCT00370227) was sponsored by GlaxoSmithKline Biologicals, Rixensart, Belgium. GSK Biologicals was involved in all stages of the study conduct and analysis. GSK Biologicals also took in charge all costs associated with the development and publishing of the present manuscript.

Presented the results of this study in parts at the 26th Annual Meeting of the European Society for Paediatric Infectious Diseases, Graz, Austria, May 13–16, 2008, and at the 7th International Symposium on Pneumococci and Pneumococcal Diseases, Tel Aviv, Israel, March 14–18, 2010.

Drs A. Karvonen, T. Korhonen, and N. Lindblad have no conflict of interest to declare; Dr T. Vesikari declares to have received honoraria/travel grants and consulting fees from GlaxoSmithKline Biologicals in the last 3 years; I. Dieussaert, P. Lommel, Drs L. Schuerman and P. Willems declare they are employed by GlaxoSmithKline Biologicals; I. Dieussaert, L. Schuerman, and P. Willems have stock ownership.

Address for correspondence: Timo Vesikari, MD, University of Tampere Medical School/FM3, Biokatu 10, 33520 Tampere, Finland. E-mail: timo.vesikari@uta.fi.

© 2010 Lippincott Williams & Wilkins, Inc.