Immunogenicity and safety of the human rotavirus vaccine Rotarix co-administered with routine infant vaccines following the vaccination schedules in Europe

Vaccine. 2010 Jul 19;28(32):5272-9. doi: 10.1016/j.vaccine.2010.05.057. Epub 2010 Jun 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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Viral / blood
  • Diphtheria-Tetanus-acellular Pertussis Vaccines / administration & dosage
  • Double-Blind Method
  • Europe
  • Haemophilus Vaccines / administration & dosage
  • Hepatitis B Vaccines / administration & dosage
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunization Schedule*
  • Immunoglobulin A / blood
  • Infant
  • Pneumococcal Vaccines / administration & dosage
  • Poliovirus Vaccine, Inactivated / administration & dosage
  • Rotavirus Vaccines / administration & dosage*
  • Rotavirus Vaccines / adverse effects
  • Rotavirus Vaccines / immunology
  • Vaccines, Attenuated / administration & dosage
  • Vaccines, Attenuated / adverse effects
  • Vaccines, Attenuated / immunology
  • Vaccines, Combined / administration & dosage


  • Antibodies, Viral
  • Diphtheria-Tetanus-acellular Pertussis Vaccines
  • Haemophilus Vaccines
  • Hepatitis B Vaccines
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Immunoglobulin A
  • Pneumococcal Vaccines
  • Poliovirus Vaccine, Inactivated
  • RIX4414 vaccine
  • Rotavirus Vaccines
  • Vaccines, Attenuated
  • Vaccines, Combined