Abstract | OBJECTIVE: DESIGN: Randomized, double-blind, controlled clinical trial. SETTING: Southern California Kaiser-Permanente Health Plan. PARTICIPANTS: 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.
|
Authors | C M Vadheim, D P Greenberg, S Partridge, J Jing, J I Ward |
Journal | Pediatrics
(Pediatrics)
Vol. 92
Issue 2
Pg. 272-9
(Aug 1993)
ISSN: 0031-4005 [Print] United States |
PMID | 8337029
(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)
|