Safety and immunogenicity of subcutaneous H. influenzae vaccines in 15-17 month-old children.
Clin Invest Med
; 14(5): 379-87, 1991 Oct.
Article
in En
| MEDLINE
| ID: mdl-1742915
ABSTRACT
To evaluate the safety and immunogenicity of subcutaneously administered PRP and PRP-D, one hundred and one healthy 15 to 17 month-old children were randomly assigned to receive two subcutaneous doses, 2 months apart, of either vaccine. The incidence of local and systemic reactions did not differ significantly between the two groups. PRP antibody levels in the pre-immunization sera of 95% of subjects were below the level associated with immediate protection from Hib disease (less than 0.15 microgram/ml). After the first dose, 32% of PRP and 70% of PRP-D (p less than 0.001) recipients achieved antibody levels of greater than or equal to 0.15 microgram/ml, and 8% and 26% (p = 0.003) respectively achieved levels greater than or equal to 1 microgram/ml, a level believed to predict long-term protection. After the second dose, antibody levels greater than or equal to 0.15 microgram/ml were reached in 38% of PRP and 88% of PRP-D (p less than 0.001) recipients and levels of greater than or equal to 1 microgram/ml were reached in 22% and 78% respectively (p less than 0.001). The geometric mean levels of PRP antibody after immunization were significantly higher in the PRP-D group after both the first and second doses (p less than 0.001). These results suggest that subcutaneous administration of both vaccines is safe, but PRP-D results in significantly higher antibody levels compared to PRP. The levels were lower than what has been reported following intramuscular administration.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Bacterial Vaccines
/
Haemophilus influenzae
/
Haemophilus Infections
Type of study:
Clinical_trials
Limits:
Female
/
Humans
/
Infant
/
Male
Language:
En
Journal:
Clin Invest Med
Year:
1991
Document type:
Article
Publication country:
CA
/
CANADA
/
CANADÁ