UNLABELLED: A total of 120 healthy Lithuanian infants were enrolled in a double-blind, randomized trial to receive one of two lots of SmithKline Beecham Biologicals' combined diphtheria, tetanus, whole cell Bordatella pertussis hepatitis B (DTPw-HB) candidate vaccine administered according to a 0, 1.5, 3-month, primary immunization schedule (beginning at approximately 3-4 months of age). The immunogenicity (based on the antibody responses elicited by each of the four vaccine components) and the reactogenicity (based on documented solicited and unsolicited symptoms) of this candidate vaccine were evaluated. Of the 120 subjects enrolled, 100 were included in the analysis of immunogenicity. One month after the third vaccine dose, all infants had protective levels of antibodies against HBsAg and tetanus toxoid and all, except one infant, had protective levels of antibodies against the diphtheria toxoid (98.9%). At this time all subjects had responded to the B. pertussis component with antibody titres greater than or equal to the assay cut-off. Data collected for all enrolled infants were included in the analysis of reactogenicity. Most local symptoms were mild and occurred within the first 48 h following vaccination. Redness was the most frequently reported local symptom and irritability was the most frequently reported general symptom. One vaccine-related serious adverse event was reported (fever, diarrhea, vomiting and irritability). This event resolved within 20 h without any complications. CONCLUSION: The combined DTPw-HB vaccine was safe, well-tolerated and immunogenic for all four antigens when administered to a population of healthy infants beginning at 3-4 months of age.
RCT Entities:
UNLABELLED: A total of 120 healthy Lithuanian infants were enrolled in a double-blind, randomized trial to receive one of two lots of SmithKline Beecham Biologicals' combined diphtheria, tetanus, whole cell Bordatella pertussis hepatitis B (DTPw-HB) candidate vaccine administered according to a 0, 1.5, 3-month, primary immunization schedule (beginning at approximately 3-4 months of age). The immunogenicity (based on the antibody responses elicited by each of the four vaccine components) and the reactogenicity (based on documented solicited and unsolicited symptoms) of this candidate vaccine were evaluated. Of the 120 subjects enrolled, 100 were included in the analysis of immunogenicity. One month after the third vaccine dose, all infants had protective levels of antibodies against HBsAg and tetanus toxoid and all, except one infant, had protective levels of antibodies against the diphtheria toxoid (98.9%). At this time all subjects had responded to the B. pertussis component with antibody titres greater than or equal to the assay cut-off. Data collected for all enrolled infants were included in the analysis of reactogenicity. Most local symptoms were mild and occurred within the first 48 h following vaccination. Redness was the most frequently reported local symptom and irritability was the most frequently reported general symptom. One vaccine-related serious adverse event was reported (fever, diarrhea, vomiting and irritability). This event resolved within 20 h without any complications. CONCLUSION: The combined DTPw-HB vaccine was safe, well-tolerated and immunogenic for all four antigens when administered to a population of healthy infants beginning at 3-4 months of age.
Authors: G Papaevangelou; E Karvelis; D Alexiou; K Kiossoglou; A Roumeliotou; A Safary; F Collard; P Vandepapeliere Journal: Vaccine Date: 1995-02 Impact factor: 3.641