Evaluation of the immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Shan 4) with EasyFourTM in Indian infants administered per EPI schedule

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

“…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. 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.…”

“…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).…”

“…6 Addition of new antigens, such as Haemophilus influenzae type b (Hib) to the existing DTP vaccines, then, resulted in the advent of tetravalent vaccines to combat more childhood vaccine preventable diseases. 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.…”