Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines.

BACKGROUND: Licensed pneumococcal conjugate vaccine (7vCRM) is usually coadministered with combination vaccines in pediatric immunization programs. Reactogenicity and safety after primary and booster vaccination with a novel 10-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) in comparison with 7vCRM, both coadministered with commonly used pediatric vaccines, was evaluated in 5 clinical studies.

METHODS: Five randomized, controlled studies in which PHiD-CV or licensed 7vCRM vaccines coadministered with various DTPa-based combination vaccines, Neisseria meningitidis serogroup C conjugate vaccines and DTPw-HBV/Hib were conducted. Local and general symptoms were solicited for 4 days after each vaccine dose, using diary cards. All adverse events were recorded for 31 days after each dose and serious adverse events throughout the entire study periods.

RESULTS: A total of 4004 subjects contributed to the safety data analyzed in this review. Fever >or=38.0 degrees C (rectal temperature) was reported after about one-third of primary or booster vaccine doses coadministered with DTPa-based vaccines and after approximately 60% of primary doses with DTPw coadministration in both PHiD-CV and 7vCRM groups. Fever >40.0 degrees C was reported after
CONCLUSIONS: The safety and reactogenicity profiles of PHiD-CV and 7vCRM were within the same range when administered for primary and booster vaccination in coadministration with other routinely used pediatric vaccines.