A multicenter, prospective, open-label, non-comparative study to evaluate the immunogenicity and tolerance of a new, fully liquid pentavalent vaccine (DTwP-HepB-Hib vaccine).

The current study was planned to assess the immunogenicity and reactogenicity of a fully liquid pentavalent combination vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and hepatitis B vaccines. Infants six to eight weeks of age were enrolled and administered the study vaccine at 0, 4 and 8 weeks of enrollment. The children were kept under observation for 30 minutes after each vaccination for local and systemic reactions. A record was maintained of suspected adverse drug reactions (ADRs) for the subsequent three days. Blood was collected for antibody titer estimations prior to the first dose and four to six weeks after the third dose. 100% of children developed protective antibody titres to D, T and HepB. 97% and 81% of vaccinees responded (2-4 fold rise in antibody titres) to the anti-fimbrial and anti-pertactin components of the pertussis antigen respectively. 100% infants developed short-term protective antibody titres to Hib (> 0.15 microg/ml) and 90% developed titres indicative of long-term protection (> 1.00 mg/ml). Fever was most commonly reported adverse event but none of the children had fever more than 102 degrees F. A few infants had mild, expected local and systemic side effects such as tenderness, erythema, induration, excessive fussiness and a change in feeding pattern. Except for one child who was withdrawn from the study for persistent crying, there were no other severe or unexpected adverse reactions reported.