title: Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine.
abstract: BACKGROUND
  The immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was assessed and compared with the 7-valent pneumococcal conjugate vaccine (7vCRM).
  
  
  METHODS
  Healthy subjects (1650) were randomized to be vaccinated with 3 doses of PHiD-CV or 7vCRM (Prevenar/Prevnar) at 2-3-4 months of age and a fourth booster dose at 12-18 months. Serotype-specific pneumococcal responses (GlaxoSmithKline's ELISA with 22F-inhibition) and opsonophagocytic activity (OPA) were measured 1 month after primary and booster vaccinations.
  
  
  RESULTS
  The primary objective to demonstrate noninferiority of PHiD-CV versus 7vCRM (in terms of percentage of subjects with antibody concentration >or=0.2 microg/mL) for at least 7 of the 10 vaccine serotypes was reached as noninferiority was demonstrated for 8 serotypes. Although, noninferiority could not be demonstrated for ELISA responses against serotypes 6B and 23F, a post-hoc analysis of the percentage of subjects with OPA titers >or=8 suggested noninferiority for the 7 serotypes common to both vaccines including 6B and 23F.Priming of the immune system against all vaccine serotypes was confirmed by robust increases in ELISA antibody levels ( approximately 6.0-17 fold) and OPA titers ( approximately 8-93 fold) after a fourth consecutive dose of PHiD-CV.
  
  
  CONCLUSIONS
  PHiD-CV induces ELISA and functional OPA antibodies for all vaccine serotypes after primary vaccination and is noninferior to 7vCRM in terms of ELISA and/or OPA threshold responses. Effective priming is further indicated by robust booster responses.
authors.affiliation: Vaccine Research Center, University of Tampere Medical School, Tampere, Finland.
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Jacek
authors.initials: J
authors.lastname: Wysocki
authors.forename: Bertrand
authors.initials: B
authors.lastname: Chevallier
authors.forename: Aino
authors.initials: A
authors.lastname: Karvonen
authors.forename: Hanna
authors.initials: H
authors.lastname: Czajka
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Arsène
authors.forename: Patricia
authors.initials: P
authors.lastname: Lommel
authors.forename: Ilse
authors.initials: I
authors.lastname: Dieussaert
authors.forename: Lode
authors.initials: L
authors.lastname: Schuerman