Study to check Safety and Immune response of SII Inactivated Salk Polio Vaccine (Adsorbed) in comparison with Sii Licensed Inactivated Poliovirus Vaccine (IPV)

A Phase II/III study, Multicenter, Double-Blind, Randomized, Active Controlled Study to evaluate Safety and Immunogenicity of SII Inactivated Salk Polio Vaccine (Adsorbed) in comparison with Sii Licensed Inactivated Poliovirus Vaccine (IPV)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042363

Enrollment

648

Registered

2022-05-04

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: SII Inactivated Salk Polio Vaccine (Adsorbed): SII Inactivated Salk Polio Vaccine (Adsorbed), produced by Serum Institute of India Pvt. Ltd., is a sterile suspension of three types of i

3 doses of SII Inactivated Salk Polio Vaccine (Adsorbed) will be administered 4 weeks apart, with the first administration given at 6- 8 weeks of age. Control Intervention1: Sii Licensed IPV: Poliomy

3 doses of Sii licensed IPV will be administered 4 weeks apart, with the first administration given at 6- 8 weeks of age

Eligibility

Inclusion criteria

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 enrollment 3. Parental ability and willingness to provide informed consent 4. Parent who intends to reside in the area with the child during the study period 5. Receipt of birth dose of OPV (within 14 days of birth)

Exclusion criteria

Exclusion criteria: 1. Presence of fever on the day of enrollment [Temporary exclusion criteria]. 2. Acute disease at the time of enrollment [Temporary exclusion criteria]. 3. Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period. (except birth dose of OPV and on national/subnational immunization days) 4. Presence of significant malnutrition (weight-for-height z-score 5. Known or suspected impairment of immunological function based on medical history and physical examination. 6. Receipt of immunoglobulin therapy and / or blood products since birth or planned administration during the study period 7. Planned concurrent participation in another clinical study at any point throughout the entire study period 8. Any clinically significant congenital malformation or genetic defect which may interfere with the evaluation of safety or immunogenicity of the IP

Design outcomes

Primary

Measure	Time frame
Percentage of participants with type-specific seroconversion for SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.Timepoint: 28 days after third vaccination	—

Secondary

Measure	Time frame
Percentage of participants with type-specific seroprotection (titers = 8) of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.Timepoint: Day 28 after the third vaccination;Type-specific geometric mean titers of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV.Timepoint: Prevaccination and 28 days after third vaccination	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Pvt Ltd.

drpsk@seruminstitute.com

Outcome results