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 <or=1.1% of PHiD-CV doses and <or=2.2% of 7vCRM doses. The incidences and intensity of general reactions were generally within the same ranges in the PHiD-CV and 7vCRM groups. Drowsiness and irritability in the study with MenC-conjugates coadministration and irritability and loss of appetite in the study with DTPw-combined vaccines coadministration tended to be slightly higher in PHiD-CV groups. No such trend was observed for solicited general symptoms with grade 3 intensity. 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.
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 <or=1.1% of PHiD-CV doses and <or=2.2% of 7vCRM doses. The incidences and intensity of general reactions were generally within the same ranges in the PHiD-CV and 7vCRM groups. Drowsiness and irritability in the study with MenC-conjugates coadministration and irritability and loss of appetite in the study with DTPw-combined vaccines coadministration tended to be slightly higher in PHiD-CV groups. No such trend was observed for solicited general symptoms with grade 3 intensity. 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.
Authors: Alassane Dicko; Olumuyiwa O Odusanya; Abdoulbaki I Diallo; Gaoussou Santara; Amadou Barry; Amagana Dolo; Aminata Diallo; Yetunde A Kuyinu; Omolara A Kehinde; Nancy François; Dorota Borys; Juan P Yarzabal; Marta Moreira; Lode Schuerman Journal: BMC Public Health Date: 2011-11-23 Impact factor: 3.295