Published online October 31, 2008
PEDIATRICS Vol. 122 No. 5 November 2008, pp. e1062-e1066 (doi:10.1542/peds.2008-1059)
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ARTICLE

Coadministration of RIX4414 Oral Human Rotavirus Vaccine Does Not Impact the Immune Response to Antigens Contained in Routine Infant Vaccines in the United States

Penelope H. Dennehy, MDa, Helen R. Bertrand, MDb, Peter E. Silas, MDc, Silvia Damaso, MScd, Leonard R. Friedland, MDd and Remon Abu-Elyazeed, MD, PhDd

a Department of Pediatrics, Rhode Island Hospital, Providence, Rhode Island
b Lowcountry Medical Associates, Charleston, South Carolina
c Wee Care Pediatrics, Layton, Utah
d GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania and Rixensart, Belgium

OBJECTIVE. This study was conducted to confirm the absence of immune interference of 2 doses of RIX4414 (Rotarix) on routine infant vaccinations in the United States.

STUDY DESIGN. A total of 484 healthy infants aged 6 to 12 weeks were randomly assigned to 1 of 2 groups to receive 3 doses of Pediarix (combined diphtheria-tetanus-acellular pertussis-hepatitis B-poliovirus vaccine [DTaP-HBV-IPV]), Prevnar (7-valent pneumococcal conjugate vaccine [PCV7]), and ActHIB (Haemophilus influenzae type b conjugate vaccine [Hib]) at 2, 4, and 6 months of age with RIX4414 either coadministered at 2 and 4 months (Co-ad) or administered separately at 3 and 5 months (Sep-ad). Serum antibodies were measured 1 month after dose 3 of the DTaP-HBV-IPV, PCV7, and Hib vaccines.

RESULTS. Antibody responses to all antigens were similar in infants in both the Co-ad and Sep-ad groups. Seroprotective antibody concentrations against diphtheria, tetanus, hepatitis B, and poliovirus types 1, 2, and 3 were achieved by ≥97.9% of the infants in both groups. Antipolyribosyl ribitol phosphate antibody levels of ≥1.0 µg/mL were achieved by 88.3% to 89.4% of infants in both groups. In both groups, ≥97.8% of the infants were seropositive for antipertussis antibodies and the 7 pneumococcal serotypes. Predefined criteria for noninferiority between groups were reached for all antigens.

CONCLUSIONS. Two doses of RIX4414 coadministered with routine infant vaccines as recommended in the United States (DTaP-HBV-IPV, PCV7, and Hib) did not impair the immune response to any of the coadministered antigens.

Key Words: DTaP-HBV-IPV • Hib • 7-valent pneumococcal conjugate vaccine • human rotavirus vaccine

Abbreviations: CDC—Centers for Disease Control and Prevention • DTaP-HBV-IPV—combined diphtheria-tetanus-acellular pertussis, hepatitis B, and inactivated poliovirus vaccine • PCV7—7-valent pneumococcal conjugate vaccine • Hib—Haemophilus influenzae type b • Co-ad—coadministration group • Sep-ad—separate administration group • IgA—immunoglobulin A • SAE—serious adverse event • CI—confidence interval • ELU—ELISA units • GMC —geometric mean antibody concentration • GMT—geometric mean antibody titer • PRP—polyribosyl ribitol phosphate • PT—pertussis toxoid • FHA—filamentous hemagglutinin • HbsAg—hepatitis B virus surface antigen • PN—pneumococcal serotype

Accepted Jul 8, 2008.


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