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

NCT05163561
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Phase
Phase 3
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Recruitment status
Completed
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Participants
1,072
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Lead sponsor
Serum Institute of India Pvt. Ltd.
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Start date
2022-01-09
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Number of sites
1
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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.
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Short title
Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 3
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Study type
Interventional
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Completion date
2023-04-29
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First posted
2021-12-20
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Registry last updated
2023-10-23
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Primary completion date
2023-04-29
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Start date
2022-01-09
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Actual participants
1,072
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Participants
1,072
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Participant count basis
Actual
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Protocol amendments
2
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Serum Institute of India Pvt. Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05163561
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ClinicalTrials.gov ID
NCT05163561
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
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.
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of participants with type-specific seroconversion

    Timeframe: Day 28 after third vaccination

    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

  1. Geometric Mean Titers

    Timeframe: Day 28 after third vaccination

    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.

  2. Reverse cumulative distribution curves of antibody titers

    Timeframe: pre-vaccination and 28 days after third vaccination

    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.

  3. Percentage of participants with type-specific seroprotection

    Timeframe: Day 28 after the third vaccination

    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.

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

    Timeframe: Day 28 after the third vaccination

    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.

Sources for outcomes
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Sex
All
Age groups
Children
Minimum age
6 Weeks
Maximum age
8 Weeks
Healthy volunteers
Yes

  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

  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
Sources for eligibility
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  • International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)Dhaka, Bangladesh
Sources for sites
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Sources for references
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)