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Effectiveness and safety of an Haemophilus influenzae type b conjugate vaccine (PRP-T) in young infants. Kaiser-UCLA Vaccine Study Group.

AbstractOBJECTIVE:
To study the safety, immunogenicity, and protective efficacy of the Haemophilus influenzae capsular polysaccharide tetanus conjugate vaccine (PRP-T).
DESIGN:
Randomized, double-blind, controlled clinical trial.
SETTING:
Southern California Kaiser-Permanente Health Plan.
PARTICIPANTS:
10,317 infants 6 to 15 weeks of age, with no known immune dysfunction, exposure to hepatitis B, or contraindication to diphtheria-tetanus-pertussis (DTP) vaccination were enrolled between August 1989 and September 1990.
INTERVENTION:
Infants were randomized to receive either PRP-T or a recombinant hepatitis B control vaccine (in addition to DTP) at approximately 2, 4, and 6 months of age.
OUTCOME MEASURES:
Adverse reactions occurring during the first 72 hours and between doses (including hospitalizations and outpatient visits) were measured using parental reporting/interviews and review of records. Invasive disease caused by H influenzae was ascertained from the time of enrollment until December 31, 1990.
RESULTS:
In October 1990, the study was prematurely terminated because of licensure of other H influenzae vaccines recommended for routine infant use. The rates of systemic and local reactions occurring within 72 hours of each vaccine dose were generally similar for infants given PRP-T and hepatitis B, but some reaction rates (local reactions, fever > or = 102 degrees F, irritability, crying) were significantly higher in the PRP-T group. In the month following receipt of vaccine, PRP-T-vaccinated infants experienced five definite seizures compared with three in the hepatitis B control group. Within 48 hours of vaccination, three seizures (two definite and one possible), which were thought to be related to vaccination, occurred in the PRP-T group, compared with none in the control group (P < .13). Overall morbidity, mortality, and hospitalization rates were similar in the two vaccine groups. Three cases of invasive disease caused by H influenzae occurred in the control group; none occurred in the PRP-T group.
CONCLUSIONS:
The PRP-T vaccine is safe and appears to be effective in preventing invasive disease caused by H influenzae type b.
AuthorsC M Vadheim, D P Greenberg, S Partridge, J Jing, J I Ward
JournalPediatrics (Pediatrics) Vol. 92 Issue 2 Pg. 272-9 (Aug 1993) ISSN: 0031-4005 [Print] United States
PMID8337029 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Bacterial Vaccines
  • Haemophilus Vaccines
  • Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
  • Hepatitis B Vaccines
  • Tetanus Toxoid
  • Vaccines, Synthetic
Topics
  • Bacterial Vaccines (adverse effects, immunology)
  • Double-Blind Method
  • Female
  • Haemophilus Vaccines
  • Hepatitis B Vaccines (adverse effects)
  • Hospitalization
  • Humans
  • Infant
  • Male
  • Seizures (etiology)
  • Tetanus Toxoid (adverse effects, immunology)
  • Vaccines, Synthetic (adverse effects)

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