Evaluation of immunogenicity and tolerance of single dose haemophilus influenzae type B (PRP-T) vaccine.

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1995-10-01
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OBJECTIVE: Evaluation of immunogenicity and acceptability of PRP-T vaccine among the Indian children. DESIGN: Multicentric, open, parallel group, comparative study of Haemophilus influenzae type B vaccine, given as single (Group I) or associated (Group II) with DPT vaccine. SETTING: Five different vaccination clinics. SUBJECTS: 125 children between the age group of 18-24 months. PARAMETERS: Measurement of (i) pre and post vaccination antibody titres of Haemophilus influenze type B specific antibody; (ii) Adverse events; and (iii) Tolerance as graded by the physician. RESULTS: Prevaccination antibody levels were > 0.15 mcg/ml in 56.3% in Group I and 35.7% in Group II. Post-seroconversion was seen in 97% in Group II receiving single and all in Group II (P > 0.05). The vaccine was well tolerated. CONCLUSIONS: The probability of subclinical infection or cross immunity is high in India. ACTHIB vaccine has a good immunogenicity and tolerance and association with DPT does not modify the immunogenicity of ACTHIB vaccine.
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Acharya D, Desai A, Nanavaty N, Pandit A, Patel V, Shah J, Shendurnikar N, Singh S, Taneja A, Vani S. Evaluation of immunogenicity and tolerance of single dose haemophilus influenzae type B (PRP-T) vaccine. Indian Pediatrics. 1995 Oct; 32(10): 1077-82