title: Immunogenicity and tolerance of H. influenzae type b, tetanus toxoid conjugate vaccine given concurrently or in combination.
abstract: The present prospective, open, controlled, randomised comparative trial was undertaken to evaluate the sero response and side effects of PRP-T Conjugate Vaccine (ACT-HIB) in infants and children aged 2 months and 16-24 months. Fifty four babies aged 2 months formed group A, 56 children aged 16-24 months formed group B. Groups A and B were further subdivided into two sub groups each destined to receive either PRP-T vaccine in association with DPT vaccine at different sites (I) or PRP-T and DPT both vaccines at the same site mixed in the same syringe (II). Group A received 3 doses at 2, 3 and 4 months of age and group B received one dose between 16-24 months. The Geometric mean titres of Anti PRP antibodies observed in primary immunisation schedule (A) and single dose vaccination schedule (B) were comparable and significantly higher to prevaccination titres. A serum anti PRP level of > 1.0 mcg/ml after immunisation is believed to correlate with long term protection. Ninety-six percent of infants in Group A and 98% in Group B achieved titres > 1.0 mcg/ml. The side effects were minimal, local and were comparable between the study and control groups, suggesting that PRP-T vaccine is highly immunogenic and well tolerated in Indian infants and children.
authors.affiliation: Department of Pediatrics, Kalawati Saran Children's Hospital, New Delhi.
authors.forename: A
authors.initials: A
authors.lastname: Kumar
authors.forename: A K
authors.initials: AK
authors.lastname: Dutta
authors.forename: A
authors.initials: A
authors.lastname: Saili
authors.forename: S
authors.initials: S
authors.lastname: Nangia
authors.forename: R
authors.initials: R
authors.lastname: Dutta
mesh_terms: D005260:Female; D006192:Haemophilus Infections / Q000276:immunology* / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D007109:Immunity; D007115:Immunization Schedule; D007194:India; D007223:Infant; D008297:Male; D012680:Sensitivity and Specificity; D013742:Tetanus / Q000276:immunology* / Q000517:prevention & control; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects; D017778:Vaccines, Combined / Q000008:administration & dosage; D018074:Vaccines, Conjugate / Q000008:administration & dosage
chemical_list: D018073:Haemophilus Vaccines; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate