Immunogenicity and safety of the human rotavirus vaccine Rotarix co-administered
with routine infant vaccines following the vaccination schedules in Europe.
Author(s): Vesikari T, Karvonen A, Prymula R, Schuster V, Tejedor JC, Thollot F,
Garcia-Corbeira P, Damaso S, Han HH, Bouckenooghe A.
Affiliation(s): University of Tampere, Medical School, FIN-33014 Tampere, Finland.
timo.vesikari@uta.fi
Publication date & source: 2010, Vaccine. , 28(32):5272-9
This study assessed the immunogenicity and safety of a human rotavirus vaccine
RIX4414; the effect of co-administration of childhood vaccines on the immune
responses was also assessed. Healthy infants aged 6-14 weeks received two doses
of RIX4414/placebo concomitantly with the primary childhood vaccination (Infanrix
hexa, Infanrix quinta,Meningitec and/or Prevnar), respecting the vaccination
schedule of each country. Anti-rotavirus IgA seroconversion rate (ELISA cut-off
20 U/ml) was measured pre-vaccination and 1-2 months post-Dose 2. Immune response
against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type
b, inactivated polio virus, pneumococcal polysaccharide conjugate (France and
Germany) and meningococcal group C conjugate vaccines (Spain) were measured
approximately 1-month post-Dose 3. An overall anti-rotavirus IgA seroconversion
rate of 86.5%(95% CI: 83.9-88.8) was observed in the RIX4414 group 1-month
post-Dose 2. The seroconversion rate in Finland and Italy (3 and 5-month
schedule) was 94.6%(95% CI: 90.0-97.5) and 92.3%(95% CI: 64.0-99.8),
respectively. Immune response to the childhood vaccines was unaffected following
co-administration with RIX4414. Reactogenicity profile was similar for RIX4414
and placebo groups. RIX4414 was immunogenic and well tolerated in European
infants and the co-administration of routine childhood vaccines with RIX4414 did
not negatively impact the immune responses to these vaccines.
|