Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

NCT05163561 | Completed Phase 3 DMC

• 1 other identifier: IPV:02
• Study Type: interventional
• Target: 1,072
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with type-specific seroconversion

  Percentage of participants with type-specific seroconversion\* on Day 28 after the third vaccination for SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV

  Day 28 after third vaccination

Secondary Outcomes (4)

• Geometric Mean Titers

  Day 28 after third vaccination

• Reverse cumulative distribution curves of antibody titers

  pre-vaccination and 28 days after third vaccination

• Percentage of participants with type-specific seroprotection

  Day 28 after the third vaccination

• Percentage of participants with type-specific post-vaccination titers ≥ 4-fold above the estimated titer of maternal antibody

  Day 28 after the third vaccination

Study Arms (4)

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot A

EXPERIMENTAL

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot A

Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot B

EXPERIMENTAL

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot B

Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot C

EXPERIMENTAL

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot C

Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C

Sii Licensed IPV

ACTIVE COMPARATOR

Sii Licensed IPV

Biological: Sii Licensed IPV

Interventions

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A BIOLOGICAL

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) Lot A

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B BIOLOGICAL

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) Lot B

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C BIOLOGICAL

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) Lot C

Sii Licensed IPV BIOLOGICAL

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.

Sii Licensed IPV

Eligibility Criteria

• Age: 6 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants as established by medical history and clinical examination before entering the study
• Age: 6-8 weeks at the time of enrolment
• Parental ability and willingness to provide informed consent
• Parent who intends to reside in the area with the infant during the study period

You may not qualify if:

• Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
• Presence of significant malnutrition (weight-for-height z-score \< -3SD median)
• Known or suspected impairment of immunological function based on medical history and physical examination.
• Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant's health or is likely to result in nonconformance to the protocol.
• A known sensitivity or allergy to any components of the Investigational Product.
• Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
• Planned concurrent participation in another clinical study at any point throughout the entire study period

Sponsors & Collaborators

• Serum Institute of India Pvt. Ltd.: lead

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)

Dhaka, 128, Bangladesh

Location

Related Publications (1)

• Kulkarni PS, Zaman K, Desai SA, Bharati S, Goswami DR, Sharmeen AT, Rana S, Haque W, Khandelwal A, Manney S, Tyagi P, Gairola S, Zade JK, Pisal SS, Dhere RM, Poonawalla CS, Lamberigts C, Parulekar V, Potey AV. Safety and immunogenicity of a reduced-dose inactivated poliovirus vaccine versus a full-dose inactivated poliovirus vaccine in infants in Bangladesh: a double-blind, non-inferiority, randomised, controlled, phase 3 trial. Lancet Infect Dis. 2025 Oct;25(10):1128-1137. doi: 10.1016/S1473-3099(25)00215-4. Epub 2025 Jun 9.

  PMID: 40505670 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• K Zaman, MD

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is designed as a double-blind (observer blind) study. Observer-blind means that during study, the participants and the study personnel responsible for the evaluation of any study endpoints (e.g. safety and immunogenicity) will be unaware of the IP administered. The IP preparation and administration will be done by designated unblinded personnel who will not participate in any of the clinical study evaluations. Unblinded study personnel will prepare/reconstitute the IP out of view of the participant as well as the site staff. Considering the fact that the IP are likely to have distinct appearances, even when drawn into syringes, the syringes will be masked with an opaque wrapping before administration. After administration, the unblinded study personnel will complete accountability label on the carton and store the used products at designated area.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 20, 2021
• Study Start: January 9, 2022
• Primary Completion: April 29, 2023
• Study Completion: April 29, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)