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A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologicals...

Mise à jour : Il y a 4 ans
Référence : EUCTR2006-003239-61

A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine and to evaluate the liquid formulation as compared to the lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose primary vaccination in healthy infants previously uninfected with HRV

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Extrait

•To demonstrate the lot-to-lot consistency of the liquid formulation of GSK Biologicals’ HRV vaccine in terms of immunogenicity as measured by serum anti-rotavirus IgA antibody levels one month after Dose 2. Consistency will be reached if, for all pairs of lots, the two-sided 95% CIs for the ratio of anti-rotavirus IgA antibody GMCs one month after Dose 2 are within the [0.5; 2] clinical limit interval. •To demonstrate non-inferiority of the liquid formulation of GSK Biologicals' HRV vaccine to that of lyophilised formulation of GSK Biologicals’ HRV vaccine in terms of seroconversion rates one month after Dose 2. Non-inferiority will be reached if the upper limit of the two-sided asymptotic standardised 95% CI for the difference in seroconversion rate between the lyophilised formulation of HRV vaccine and (minus) the liquid formulation of HRV vaccine is less than or equal to 10%.

Critère d'inclusion

  • Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV

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