title: Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines.
abstract: 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.affiliation: Service de Pédiatrie, Hôpital Louis Mourier, Colombes, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Chevallier
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Jerzy
authors.initials: J
authors.lastname: Brzostek
authors.forename: Markus
authors.initials: M
authors.lastname: Knuf
authors.forename: Nancy
authors.initials: N
authors.lastname: Bermal
authors.forename: Javier
authors.initials: J
authors.lastname: Aristegui
authors.forename: Dorota
authors.initials: D
authors.lastname: Borys
authors.forename: Jan
authors.initials: J
authors.lastname: Cleerbout
authors.forename: Patricia
authors.initials: P
authors.lastname: Lommel
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman