> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluation-of-safety-and-immunogenicity-of-inactivated-ce7f1f29-a026-4a28-af52-da0ecf64f1a3 > Record changed: 2026-11-04 # Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine NCT05163561 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Participants 1,072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Lead sponsor Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Start date 2022-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Short title** Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Dates **Completion date** 2023-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **First posted** 2021-12-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Registry last updated** 2023-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Primary completion date** 2023-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Start date** 2022-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Size and sites **Actual participants** 1,072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Participants** 1,072 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Lead sponsor** Serum Institute of India Pvt. Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Identifiers **Registry ID** NCT05163561 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **ClinicalTrials.gov ID** NCT05163561 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Study design **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Outcomes ### Primary outcomes 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 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Eligibility **Sex** All **Age groups** Children **Minimum age** 6 Weeks **Maximum age** 8 Weeks **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Sites - International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)Dhaka, Bangladesh Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## References - PubMed 40505670 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40505670/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05163561) ## Related records ### Drugs (1) - [Poliovirus vaccine inactivated](https://trialight.com/data/asset/poliovirus-vaccine-inactivated-73d8bd8f-cda2-4090-885b-f54c53ea52ef.md) ### Lead sponsors (1) - [Serum Institute of India Pvt. Ltd.](https://trialight.com/data/company/serum-institute-of-india-pvt-ltd-83f1638e-64f7-4ee9-9ca0-7ae346be8b28.md) ### Conditions (1) - [Poliomyelitis](https://trialight.com/data/condition/poliomyelitis-5f8120f0-b67f-5e12-862f-914f03ab5ac7.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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