EFFICACY OF HEPTAVALENT PNEUMOCOCCAL
CONJUGATE VACCINE (Wyeth) IN 37,868 INFANTS AND CHILDREN: UPDATE ON
PNEUMONIA, OTITIS MEDIA AND INVASIVE DISEASE
Black S, Shinefield S, Ray P, Lewis E,
Fireman B, The Kaiser Permanente Vaccine Study Group1; Austrian
R2, Siber G and Hackell J3
1Kaiser Permanente Vaccine Study
Center, Oakland, CA
2University of Pennsylvania, School
of Medicine, Philadelphia, PA
3Wyeth Lederle Vaccines and
Pediatrics, Pearl River, NY, USA
OBJECTIVE:
To evaluate the safety, immunogenicity and efficacy (invasive disease,
pneumonia, otitis media) of the Wyeth seven valent pneumococcal conjugate
vaccine in infancy.
METHODS:
Beginning in October 1995, the Wyeth Lederle Heptavalent CRM197 (PCV) was offered to infants at 2,
4, 6 & 12-15 mo. in a double blind trial. 37,000 children were randomly assigned 1:1 to receive
either the PCV or meningococcus type C CRM197 conjugate. Outcomes included invasive disease,
clinical otitis media and pneumonia.
RESULTS:
As of unblinding, 39 of 40 cases of vaccine serotype per protocol invasive
disease were in controls for an efficacy of 97.4%; and the vaccine
prevented 89.1% of all disease regardless of serotype. For pneumonia, outcomes included a
clinical diagnosis of pneumonia, x-ray confirmed pneumonia and
consolidation >2.5cm as agreed to by both a pediatric and radiologist
review of the films. Vaccine
efficacy (95% CI) was 11.4% (1.3-20.5%) for any pneumonia visit, 33%
(7.3-51.5%) for pneumonia with an abnormal x-ray and 73.1% (38.0-88.3%) for
preventing pneumonia with consolidation.
CONCLUSION:
This heptavalent pneumococcal conjugate appears to be highly effective in
preventing invasive disease and offers the potential to reduce the global
burden of pneumonia morbidity and mortality in the first year of life.