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

A Phase III, Double Blind, Randomized, Active Controlled Study to Evaluate Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine

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.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A; Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B; Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C; Biological: Sii Licensed IPV

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.

• Study Type: Interventional
• Enrollment (Actual): 1072
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Prasad S Kulkarni, MD; Phone Number: 2384 +91-20-26602384; Email: drpsk@seruminstitute.com
• Study Contact Backup: Name: Sajjad A Desai, MD; Phone Number: 2781 +91-20-26602781; Email: sajjad.desai@seruminstitute.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh, 128
    • International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 1 month (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of fever on the day of enrolment [Temporary exclusion criteria].
2. Acute disease at the time of enrolment [Temporary exclusion criteria].
3. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
4. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3-months prior to inclusion or planned during the study.
5. Presence of significant malnutrition (weight-for-height z-score < -3SD median)
6. Known or suspected impairment of immunological function based on medical history and physical examination.
7. 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.
8. A known sensitivity or allergy to any components of the Investigational Product.
9. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period
10. Planned concurrent participation in another clinical study at any point throughout the entire study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SII Inactivated Salk Polio Vaccine (Adsorbed) Lot A	Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A; 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.
Experimental: SII Inactivated Salk Polio Vaccine (Adsorbed) Lot B	Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B; 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.
Experimental: SII Inactivated Salk Polio Vaccine (Adsorbed) Lot C	Biological: SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C; 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.
Active Comparator: Sii Licensed IPV	Biological: Sii Licensed IPV; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers	Type-specific geometric mean titers on day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.	Day 28 after third vaccination
Reverse cumulative distribution curves of antibody titers	Type-specific reverse cumulative distribution curves of antibody titers on pre-vaccination and 28 days after third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.	pre-vaccination and 28 days after third vaccination
Percentage of participants with type-specific seroprotection	Percentage of participants with type-specific seroprotection (titers ≥ 8) on Day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.	Day 28 after the third vaccination
Percentage of participants with type-specific post-vaccination titers ≥ 4-fold above the estimated titer of maternal antibody	Percentage of participants with type-specific post-vaccination titers ≥ 4-fold above the estimated titer of maternal antibody on day 28 after the third vaccination of three cGMP lots of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.	Day 28 after the third vaccination

Collaborators and Investigators

• Sponsor: Serum Institute of India Pvt. Ltd.
• Investigators: Principal Investigator: K Zaman, MD, International Centre for Diarrhoeal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2022
• Primary Completion (Actual): April 29, 2023
• Study Completion (Actual): April 29, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 17, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Neuroinflammatory Diseases; Poliomyelitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: IPV:02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No