Extract

The main objective of the study is to demonstrate that GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary vaccination course, is non-inferior to Prevenar, both co-administered with DTPa-HBV-IPV and Hib-MenC vaccines, in terms of post-immunization febrile reactions with rectal fever > 39.0°C. Criteria for safety: Non-inferiority will be demonstrated if the upper limit of the 95% CI of the difference (10Pn-PD-DiT + Hib-MenC group minus Prevenar group), in terms of percentage of subjects with rectal fever >39.0°C, is lower than 10%.

Inclusion criteria

• Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b

Links

• euctr
• ictrp
• ictrp
• euctr