title: Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Northern California Kaiser Permanente Vaccine Study Center Group.
abstract: OBJECTIVE
  To determine the efficacy, safety and immunogenicity of the heptavalent CRM197 pneumococcal conjugate vaccine against invasive disease caused by vaccine serotypes and to determine the effectiveness of this vaccine against clinical episodes of otitis media.
  
  
  METHODS
  The Wyeth Lederle Heptavalent CRM197 (PCV) was given to infants at 2, 4, 6 and 12 to 15 months of age in a double blind trial; 37,868 children were randomly assigned 1:1 to receive either the pneumococcal conjugate vaccine or meningococcus type C CRM197 conjugate. The primary study outcome was invasive disease caused by vaccine serotype. Other outcomes included overall impact on invasive disease regardless of serotype, effectiveness against clinical otitis media visits and episodes, impact against frequent and severe otitis media and ventilatory tube placement. In addition the serotype-specific efficacy against otitis media was estimated in an analysis of spontaneously draining ears.
  
  
  RESULTS
  In the interim analysis in August, 1998, 17 of the 17 cases of invasive disease caused by vaccine serotype in fully vaccinated children and 5 of 5 of partially vaccinated cases occurred in the control group for a vaccine efficacy of 100%. Blinded case ascertainment was continued until April, 1999. As of that time 40 fully vaccinated cases of invasive disease caused by vaccine serotype had been identified, all but 1 in controls for an efficacy of 97.4% (95% confidence interval, 82.7 to 99.9%), and 52 cases, all but 3 in controls in the intent-to-treat analysis for an efficacy of 93.9% (95% confidence interval, 79.6 to 98.5%). There was no evidence of any increase of disease caused by nonvaccine serotypes. Efficacy for otitis media against visits, episodes, frequent otitis and ventilatory tube placement was 8.9, 7.0, 9.3 and 20.1% with P < 0.04 for all. In the analysis of spontaneously draining ears, serotype-specific effectiveness was 66.7%.
  
  
  CONCLUSIONS
  This heptavalent pneumococcal conjugate appears to be highly effective in preventing invasive disease in young children and to have a significant impact on otitis media.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. Steve.Black@kp.org
authors.forename: S
authors.initials: S
authors.lastname: Black
authors.forename: H
authors.initials: H
authors.lastname: Shinefield
authors.forename: B
authors.initials: B
authors.lastname: Fireman
authors.forename: E
authors.initials: E
authors.lastname: Lewis
authors.forename: P
authors.initials: P
authors.lastname: Ray
authors.forename: J R
authors.initials: JR
authors.lastname: Hansen
authors.forename: L
authors.initials: L
authors.lastname: Elvin
authors.forename: K M
authors.initials: KM
authors.lastname: Ensor
authors.forename: J
authors.initials: J
authors.lastname: Hackell
authors.forename: G
authors.initials: G
authors.lastname: Siber
authors.forename: F
authors.initials: F
authors.lastname: Malinoski
authors.forename: D
authors.initials: D
authors.lastname: Madore
authors.forename: I
authors.initials: I
authors.lastname: Chang
authors.forename: R
authors.initials: R
authors.lastname: Kohberger
authors.forename: W
authors.initials: W
authors.lastname: Watson
authors.forename: R
authors.initials: R
authors.lastname: Austrian
authors.forename: K
authors.initials: K
authors.lastname: Edwards
mesh_terms: D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D003257:Consumer Product Safety; D004311:Double-Blind Method; D006801:Humans; D007223:Infant; D010033:Otitis Media / Q000382:microbiology / Q000517:prevention & control*; D011008:Pneumococcal Infections / Q000276:immunology* / Q000517:prevention & control; D012307:Risk Factors; D012703:Serotyping; D013296:Streptococcus pneumoniae / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D001428:Bacterial Vaccines; D018074:Vaccines, Conjugate