Clinical Research Directory

Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)

This is a Phase I/II, double-blind, randomized, active controlled, multi-centric clinical trial to assess the reactogenicity, safety and immunogenicity of a SIIPL DTwP-HepB-rPV-Hib vaccine in comparison with HEXASIIL® in healthy toddlers and infants. This trial is planned as a Phase I/II trial with two age cohorts to be enrolled sequentially, starting with healthy toddlers and subsequently extending to healthy infants. In Phase I of the trial, after at least one parent signs the informed consent and the participant's eligibility is confirmed, healthy toddlers aged 12-24 months will be randomized in a 2:1 ratio, to receive 0.5 mL of either of the vaccines intramuscularly in the upper anterolateral aspect of the thigh. Following vaccination, all toddlers will be observed at the site for minimum 30 (+15) minutes for any Iimmediate Adverse Event (IAE). Solicited Adverse Events (AEs) will be actively collected for 7 days post vaccination. Unsolicited AEs and Serious AEs will be collected throughout the trial from the time of signing informed consent till 28 days post vaccination. Blood samples for immunogenicity assessment will be obtained from all participating toddlers at Visit 1 (Prior to vaccination) and at Visit 4. A Data Safety Monitoring Board (DSMB) meeting will be convened for the evaluation of 7-day safety data in all participants. The DSMB shall review the safety data and provide recommendations to initiate Phase II of the trial. Additionally, Safety Review Comitte (SRC) will review the 24-hour safety data from the initial sentinel group (three participants) and give advice on progression to the subsequent enrolment in Phase I. After at least one parent signs the informed consent and the participant's eligibility is confirmed, all infants will be randomized in 2:1 ratio to receive a 3-dose primary vaccination series at 6, 10 and 14 weeks of age. Each participant will receive 0.5 mL of either vaccine intramuscularly in the upper anterolateral aspect of the thigh. Following each vaccination, all infants will be observed at the site for minimum 30 (+15) minutes for any IAEs. Active follow up for solicited AEs will be conducted over the 7-day period after each vaccination. Unsolicited AE/SAEs will be collected from signing of informed consent till Visit 10. Blood samples for immunogenicity assessment will be obtained from all participating infants at Visit 1 (Prior to vaccination) and at Visit 10.

Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV

In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV. SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens. Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.