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

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 3

Locations

Bangladesh

Study Type

Interventional

Intervention

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

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Presence of fever on the day of enrolment [Temporary exclusion criteria].
Acute disease at the time of enrolment [Temporary exclusion criteria].
Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
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.
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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT05163561

First Posted

December 3, 2021

Last Updated

October 20, 2023

Sponsor

Serum Institute of India Pvt. Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05163561

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

January 9, 2022 (Actual)

Primary Completion Date

April 29, 2023 (Actual)

Study Completion Date

April 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Serum Institute of India Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

1072 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot A

Arm Type

Experimental

Arm Description

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot A

Arm Title

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot B

Arm Type

Experimental

Arm Description

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot B

Arm Title

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot C

Arm Type

Experimental

Arm Description

SII Inactivated Salk Polio Vaccine (Adsorbed) Lot C

Arm Title

Sii Licensed IPV

Arm Type

Active Comparator

Arm Description

Sii Licensed IPV

Intervention Type

Biological

Intervention Name(s)

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot A

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot B

Intervention Description

Intervention Type

Biological

Intervention Name(s)

SII Inactivated Salk Polio Vaccine (Adsorbed) - Lot C

Intervention Description

Intervention Type

Biological

Intervention Name(s)

Sii Licensed IPV

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of participants with type-specific seroconversion

Description

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

Time Frame

Day 28 after third vaccination

Secondary Outcome Measure Information:

Title

Geometric Mean Titers

Description

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.

Time Frame

Day 28 after third vaccination

Title

Reverse cumulative distribution curves of antibody titers

Description

Time Frame

pre-vaccination and 28 days after third vaccination

Title

Percentage of participants with type-specific seroprotection

Description

Time Frame

Day 28 after the third vaccination

Title

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

Description

Time Frame

Day 28 after the third vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: Presence of fever on the day of enrolment [Temporary exclusion criteria]. Acute disease at the time of enrolment [Temporary exclusion criteria]. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period. 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. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

K Zaman, MD

Organizational Affiliation

International Centre for Diarrhoeal Disease Research, Bangladesh

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Dhaka

ZIP/Postal Code

128

Country

Bangladesh

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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