Evaluation of immunogenicity and safety of two formulations of human rotavirus (HRV) vaccine, in healthy infants starting at age 6-12 weeks

Update Il y a 4 ans
Reference: EUCTR2016-000598-19

Woman and Man

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Extract

•To demonstrate the lot-to-lot consistency of the PCV-free liquid HRV vaccine in terms of immunogenicity as measured by serum anti-RV IgA antibody concentrations 1-2 months after Dose 2. •To demonstrate the immunological non-inferiority of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine in terms of seroconversion rates 1-2 months after Dose 2. •To demonstrate the non-inferiority of the PCV-free liquid HRV vaccine to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.


Inclusion criteria

  • Rotarix is indicated to prevent infants against gastroenteritis (GE) due to rotavirus (RV)