Extrait

First primary objective: Non-inferiority of the candidate pneumococcal vaccine (dPly 10µg and PhtD 10µg) versus 10Pn-PD-DiT vaccine when administered with DTPa-HBV-IPV/Hib as a 3-dose primary vaccination, in terms of post-primary immunization fever > 40.0°C (rectal temperature) with causal relationship to vaccination. Second primary objective (sequential): Non-inferiority of the candidate pneumococcal vaccine (dPly 30µg and PhtD 30µg) versus 10Pn-PD-DiT vaccine when administered with DTPa-HBV-IPV/Hib as a 3-dose primary vaccination, in terms of post-primary immunization fever > 40.0°C (rectal temperature) with causal relationship to vaccination. (see protocol for detailed criteria for non-inferiority)

Critère d'inclusion

• Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of the first vaccination and 12-15 months of age at the time of booster vaccination

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