Immunogenicity and safety of the human rotavirus vaccine Rotarix co-administered with routine infant vaccines following the vaccination schedules in Europe.
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.
University of Tampere, Medical School, FIN-33014 Tampere, Finland. timo.vesikari@uta.fi
Timo
T
Vesikari
Aino
A
Karvonen
Roman
R
Prymula
Volker
V
Schuster
Juan C
JC
Tejedor
Franck
F
Thollot
Pilar
P
Garcia-Corbeira
Silvia
S
Damaso
Htay-Htay
HH
Han
Alain
A
Bouckenooghe
D000914:Antibodies, Viral / Q000097:blood; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage; D004311:Double-Blind Method; D005060:Europe; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007115:Immunization Schedule; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D022242:Pneumococcal Vaccines / Q000008:administration & dosage; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage; D022243:Rotavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage
D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007070:Immunoglobulin A; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated; D017778:Vaccines, Combined