Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III study has been designed to compare the SII Inactivated Salk Polio Vaccine
      (Adsorbed) with Sii licensed IPV by testing the vaccine in infants (three doses administered
      4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in
      the induction of specific poliovirus neutralizing antibody (PVNA) to poliovirus type 1, type
      2 and type 3 by these vaccines. The study will also evaluate lot-to-lot consistency in the
      manufacture of SII Inactivated Salk Polio Vaccine (Adsorbed) by demonstrating equivalence in
      the induction of PVNA across three production lots.
    

Detailed description: 
      The study is designed as a double-blind, randomized, active-controlled Phase III study with
      four groups of infants (n=268 per group) receiving either SII Inactivated Salk Polio Vaccine
      (Adsorbed) from the three lots or Sii licensed IPV.

      Participants will be screened for eligibility with their parental consent and will be
      selected for the study according to inclusion and exclusion criteria. A total of 1072
      participants will be enrolled.

      Following vaccination, enrolled participants will remain in the clinic for at least 30
      minutes for observation. During this time, they will be closely monitored for any immediate
      adverse events. Safety will be evaluated by active surveillance for solicited adverse events
      over the 4-day period after each vaccination in all participants. In addition, surveillance
      for unsolicited AEs and SAEs will be carried out over the period from first vaccination and
      28 days after the third vaccination in all participants.

      The immunogenicity will be assessed by measuring the PVNA to poliovirus type 1, type 2 and
      type 3 using a standardized microneutralization test in the sera samples of the participants.
    

Intervention name(s): SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A; SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B; SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C; Sii Licensed IPV
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.; SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.; SII Inactivated Salk Polio Vaccine (Adsorbed) produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). It is a highly purified, adjuvanted reduced antigen content of inactivated poliovirus vaccine.; Poliomyelitis Vaccine (Inactivated), produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of inactivated poliovirus: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). Poliomyelitis Vaccine (Inactivated) is a highly purified, inactivated poliovirus vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study participants aged 6 to 8 weeks will be enrolled and randomized into 1:1:1:1 ratio to receive either the SII inactivated Salk polio vaccine (adsorbed) from one of the three lots (Lot A or Lot B or Lot C) or the Sii licensed inactivated poliovirus vaccine (IPV).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention