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Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States.
Pediatrics. 2008 Nov; 122(5):e1062-6.Ped

Abstract

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 >or=97.9% of the infants in both groups. Antipolyribosyl ribitol phosphate antibody levels of >or=1.0 microg/mL were achieved by 88.3% to 89.4% of infants in both groups. In both groups, >or=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.

Authors+Show Affiliations

Department of Pediatrics, Rhode Island Hospital, Providence, Rhode Island 02903, USA. pdennehy@lifespan.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18977955

Citation

Dennehy, Penelope H., et al. "Coadministration of RIX4414 Oral Human Rotavirus Vaccine Does Not Impact the Immune Response to Antigens Contained in Routine Infant Vaccines in the United States." Pediatrics, vol. 122, no. 5, 2008, pp. e1062-6.
Dennehy PH, Bertrand HR, Silas PE, et al. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008;122(5):e1062-6.
Dennehy, P. H., Bertrand, H. R., Silas, P. E., Damaso, S., Friedland, L. R., & Abu-Elyazeed, R. (2008). Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics, 122(5), e1062-6. https://doi.org/10.1542/peds.2008-1059
Dennehy PH, et al. Coadministration of RIX4414 Oral Human Rotavirus Vaccine Does Not Impact the Immune Response to Antigens Contained in Routine Infant Vaccines in the United States. Pediatrics. 2008;122(5):e1062-6. PubMed PMID: 18977955.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. AU - Dennehy,Penelope H, AU - Bertrand,Helen R, AU - Silas,Peter E, AU - Damaso,Silvia, AU - Friedland,Leonard R, AU - Abu-Elyazeed,Remon, PY - 2008/11/4/pubmed PY - 2008/12/17/medline PY - 2008/11/4/entrez SP - e1062 EP - 6 JF - Pediatrics JO - Pediatrics VL - 122 IS - 5 N2 - 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 >or=97.9% of the infants in both groups. Antipolyribosyl ribitol phosphate antibody levels of >or=1.0 microg/mL were achieved by 88.3% to 89.4% of infants in both groups. In both groups, >or=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. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/18977955/Coadministration_of_RIX4414_oral_human_rotavirus_vaccine_does_not_impact_the_immune_response_to_antigens_contained_in_routine_infant_vaccines_in_the_United_States_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=18977955 DB - PRIME DP - Unbound Medicine ER -