The immunogenicity and safety of Haemophilus influenzae type b-tetanus toxoid conjugate vaccine in Gambian infants.
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| Abstract |
In developing countries, Haemophilus influenzae type b is a major cause of meningitis and pneumonia in the 1st year of life. The safety and immunogenicity of a Haemophilus influenzae type b polysaccharide-tetanus toxoid conjugate vaccine (PRP-T) were evaluated in two studies of Gambian infants. In the first study, 131 infants were recruited and randomized into three groups to receive PRP-T at 1 and 3 months (group A), PRP-T at 2 and 4 months (group B) or no PRP-T (group C). The liquid form of PRP-T was used. The geometric mean titre (GMT) of anti-PRP antibody 1 month after the second dose was 0.26 microgram/ml in group A and 0.41 microgram/ml in group B. In the second study, 66 infants were given PRP-T in the lyophilized form at 2, 3 and 4 months of age. The GMT 1 month after the first dose was 0.09 microgram/ml, after the second 0.74 microgram/ml and after the third 2.32 micrograms/ml. After the third dose, 72% of children had antibody levels greater than 1.0 microgram/ml and 93% greater than 0.15 microgram/ml. No serious side-effects were observed and the rate of adverse reactions was consistent with the concurrent administration of diphtheria-tetanus-pertussis (DPT) vaccine.
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| Authors | E K Mulholland, P Byass, H Campbell, B Fritzell, A M Greenwood, J Todd, B M Greenwood |
| Journal | Annals of tropical paediatrics (Ann Trop Paediatr) Vol. 14 Issue 3 Pg. 183-8 ( 1994) ISSN: 0272-4936 [Print] England |
| PMID | 7825990 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial) |
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