Key result
Concomitant pentavalent rotavirus and hexavalent vaccination yields noninferior immune responses versus hexavalent vaccine alone.
Why the study?
Does pentavalent rotavirus vaccine maintain immunogenicity and safety when administered concomitantly with a hexavalent vaccine in healthy infants?
RCT (n=403)
Does pentavalent rotavirus vaccine maintain immunogenicity and safety when administered concomitantly with a hexavalent vaccine in healthy infants?
Absolute Event Rate: 91.4% vs 95.1%
Concomitant administration of the pentavalent rotavirus vaccine with routine hexavalent childhood vaccines is safe and does not compromise the immunogenicity of either vaccine.
Supports routine coadministration to streamline infant immunization schedules; extends safety and efficacy data.
BACKGROUND: The pentavalent rotavirus vaccine (PRV), RotaTeq, can be concomitantly administered with most routine childhood vaccines. This study evaluated the immunogenicity and reactogenicity of PRV when used concomitantly with a hexavalent vaccine containing diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b. METHODS: Healthy infants (N = 403) received hexavalent vaccine concomitantly with either PRV or placebo at 2, 3, and 4 months of age. Antibody responses were measured immediately before and 42 +/- 3 days after vaccination. Parents/legal guardians recorded all adverse events for 14 days after vaccination. RESULTS: Seroprotective titers for hepatitis B (hepatitis B surface antigen > or =10 mIU/mL) were achieved by 97.8% of subjects in both vaccine treatment groups. Seroprotective titers to H. influenzae type b (polyribosylribitol phosphate > or =0.15 microg/mL) were achieved by 91.4% of subjects receiving both vaccines and 95.1% of subjects receiving only hexavalent vaccine. Seroprotective titers to diphtheria, tetanus, and poliovirus were also comparable between the vaccine treatment groups, as were geometric mean antibody titers to the pertussis antigens. Among PRV recipients, 92% had a > or =3-fold rise in serum antirotavirus immunoglobulin A levels. Concomitant administration was well tolerated. The incidence of adverse events was similar for both groups, with no statistically significant increases in fever, vomiting, diarrhea, or irritability. CONCLUSIONS: In this study, concomitant administration of PRV with hexavalent vaccine was well tolerated and the immune responses to the antigens of the hexavalent vaccine were noninferior when compared with those of the control group. In addition, PRV was immunogenic when administered concomitantly with hexavalent vaccine.
No takes yet. Share an insight, caveat, or question.
Ciarlet et al. (2009) conducted an RCT in Healthy infants (n=403). Pentavalent rotavirus vaccine (PRV) vs. Placebo was evaluated on Seroprotective titers to H. influenzae type b (polyribosylribitol phosphate >=0.15 microg/mL). Concomitant administration of the pentavalent rotavirus vaccine with a hexavalent vaccine yielded noninferior immune responses, including 91.4% vs 95.1% seroprotection for H. influenzae type b.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: