Skip Navigation LinksSkip Navigation Links
Centers for Disease Control and Prevention
Safer Healthier People
Blue White
Blue White
bottom curve
CDC Home Search Health Topics A-Z spacer spacer
Blue curve MMWR spacer

Notices to Readers Food and Drug Administration Approval of Use of a Haemophilus b Conjugate Vaccine for Infants

On December 13, 1990, the Food and Drug Administration (FDA) approved the Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PRP-OMP) (manufactured by Merck Sharpe and Dohme and distributed as PedvaxHIB). This vaccine is approved for use in a two-dose primary immunization schedule for infants at 2 and 4 months of age, with a booster dose at 12 months of age. Previously unvaccinated infants 5-10 months of age should receive two doses of PedvaxHIB 2 months apart and a booster dose at 12 months of age. Children 11-14 months of age not previously vaccinated should receive two doses 2 months apart. Previously unvaccinated children 15-60 months of age should receive one dose and do not require a booster. This dosing schedule differs from that for the Haemophilus b Conjugate Vaccine (Diphtheria CRM 197 Protein Conjugate) (HbOC) licensed for infant use in October 1990 (1).

Haemophilus influenzae type b (Hib) is the major cause of bacterial meningitis in children less than 5 years of age, with the peak incidence in children less than 1 year of age (2). The principal efficacy trial for PRP-OMP was conducted in approximately 5000 Native American infants in Arizona and New Mexico, half of whom received the vaccine in a prospective placebo-controlled study (M. Santosham, personal communication, 1990). A total of 3486 infants completed the primary two-dose regimen. Fourteen cases of Hib invasive disease occurred in unvaccinated children, compared with one case in fully vaccinated children, indicating an efficacy of 93% (95% confidence interval=53%-99%). The Immunization Practices Advisory Committee will issue a complete statement on this vaccine. Reported by: Center for Biologics Evaluation and Research, Food and Drug Administration. Center for Infectious Diseases; Center for Prevention Svcs, CDC.


  1. CDC. Food and Drug Administration approval of use of Haemophilus b Conjugate Vaccine for infants. MMWR 1990;39:698-9.

  2. Schlech WF, Ward JI, Band JD, et al. Bacterial meningitis in the United States, 1978 through 1981: the National Bacterial Meningitis Surveillance Study. JAMA 1985;253:1749-54.

Disclaimer   All MMWR HTML documents published before January 1993 are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to

Page converted: 08/05/98


Safer, Healthier People

Morbidity and Mortality Weekly Report
Centers for Disease Control and Prevention
1600 Clifton Rd, MailStop E-90, Atlanta, GA 30333, U.S.A


Department of Health
and Human Services

This page last reviewed 5/2/01