A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6–14 weeks

A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants

“…In the present study, long-term seroprotection (> 1.0 mg/ml) of anti PRP-T in Easyfour Ò -TT, 4 weeks after the third dose (in a schedule of 6, 10 and 14 weeks) was 95.8% in comparison to Quadrovax (96.67%). These results were also comparable to other published studies of DTwP-Hib such as TETRAct-Hib (97.7%) 13 and Shan 4(92.68%). 7 Easyfour Ò -TT will be particularly useful when Hepatitis B is to be administered at birth followed by subsequent doses at 1 and 6 months of age, In such a case, it will be administered in primary immunisation schedule at 6, 10 and 14 weeks 7 as per Expanded Program of Immunization (EPI) recommendations.…”

“…The vaccines were immunogenic for all vaccine constituents including PRP (Hib). 13 In Canada, a decrease in the rate of invasive Hib diseases was observed following license and application of DTwP/PRP-T vaccines. 16 In the current study, conducted in India, Easyfour Ò -TT a fully liquid tetravalent combination vaccine manufactured by Panacea Biotec Ltd. administered at 6, 10 and 14 weeks has been evaluated.…”

“…If, Hepatitis B is to be administered at 6, 10 and 14 weeks as a combination vaccine as per EPI, a tetravalent vaccine containing Hib such as Easyfour Ò -TT, can be administered as booster dose at 15-18 months. 13 244 subjects were enrolled (122 in each group) who received at least one vaccine dose. Four subjects (02 in each group) did not return after 1st visit and their data was not available (they did not return diary card).…”

“…This baseline seroprotection is possibly due to passive transfer of antibodies to neonates from mothers who were administered of tetanus toxoid vaccine during pregnancy, consistent with the previously published literature. [7][8][9][10][11][12][13][14][15] 100% subjects in the Easyfour Ò -TT and Quadrovax Ò groups achieved seroprotection against tetanus toxoid post-vaccination. The post vaccination anti-tetanus GMTs were similar between recipients of Easyfour Ò -TT(GMT 1.51, [1.30-1.75]) and Quadrovax Ò (GMT 1.33, [1.18-1.49]) (p D 0.069) ( Table 3).…”

“…7 DTwP-Hib combination vaccines are generally available as a composite of lyophilized Hib reconstituted in liquid DTwP vaccine. [8][9][10][11][12][13][14] Since a fully liquid tetravalent combination vaccine does not require reconstitution and is more convenient to handle, Panacea Biotec Ltd. has indigenously developed Easyfour Ò -TT, a fully liquid tetravalent vaccine.…”