| Abstract | OBJECTIVE: To assess the immunogenicity and reactogenicity of a tetanus conjugate Haemophilus influenzae type b vaccine (Act-Hib) when extemporaneously mixed and administered as a DTwP-Hib combination using an Indian DTwP vaccine (BE DTwP) in comparison with a licensed DTwP-Hib combination vaccine. METHODS: 378 healthy infants were enrolled and randomly allocated to receive either three doses, at 6, 10 and 14 weeks of age, of Act-Hib in combination with BE DTwP (Group A, n = 160), TetrAct-Hib (Group B, n = 160), or BE DTwP and Act-Hib as separate injections (Group C, n = 58). Sera collected before the first dose and one month after the third dose were tested for antibodies to vaccine antigens. Safety was determined using parental diary cards. RESULTS: Anti-Hib antibody concentrations indicative of short-term protection (> 0.15 g/ml) were elicited in all but one subject in Group A (99.3%), and all subjects in Groups B and C. The concentration of 1 g/ml, considered to provide long-term protection, was achieved in 96.7%, 100% and 98.2% of the infants in Groups A, B and C, respectively. All children displayed satisfactory responses to the three DTwP component antigens, TetrAct-Hib eliciting higher titers against diphtheria and tetanus than BE DTwP. No vaccine-associated serious adverse events occurred. The BE DTwP vaccine was associated with more reports of fever than TetrAct-Hib, but most symptoms were regarded as mild and all resolved without sequelae. CONCLUSIONS: Combining Act-Hib and a local DTwP vaccine did not affect the anti-Hib response. In countries where DTwP vaccine available for use in the EPI program is manufactured by a local or other developing country manufacturer, mixing it with lyophilised Act-Hib is a reasonable option though the immunogenicity may have to be documented before routine use. However, use of TetrAct-Hib combination vaccine would be preferable in view of its lower reactogenicity and superior immunogenicity with respect to diphtheria and tetanus. |
| Authors | Thomas Cherian, Niranjan Thomas, P Raghupathy, Isabelle Durot, Anil Dutta
(Affiliation: Department of Child Health, Christian Medical College and Hospital, Vellore, Tamil Nadu, India. cheri at cmcvellore.ac.in)
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| Journal | Indian pediatrics
(Indian Pediatr)
Vol. 39
Issue 5
Pg. 427-36
(May 2002)
ISSN: 0019-6061 India |
| PMID | 12037271
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
|
| Chemical References |
- Diphtheria Toxoid
- Haemophilus Vaccines
- Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
- Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate
- Tetanus Toxoid
- Vaccines, Combined
- Vaccines, Conjugate
|
| Topics |
- Diphtheria Toxoid
(adverse effects, immunology, therapeutic use)
- Female
- Haemophilus Infections
(prevention & control)
- Haemophilus Vaccines
(adverse effects, immunology, therapeutic use)
- Haemophilus influenzae type b
(immunology)
- Humans
- Immunization Schedule
- India
- Infant
- Male
- Tetanus Toxoid
(adverse effects, immunology, therapeutic use)
- Vaccines, Combined
(adverse effects, immunology)
- Vaccines, Conjugate
|
