Study to check Safety and Immune response of SII Inactivated Salk Polio Vaccine (Adsorbed) in comparison with Sii Licensed Inactivated Poliovirus Vaccine (IPV)
- Conditions
- Prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3
- Registration Number
- CTRI/2022/05/042363
- Lead Sponsor
- Serum Institute of India Pvt Ltd
- Brief Summary
The study is designed as a multicenter, double-blind, randomized, active controlled Phase II/III study with two groups of infants (n=324 per group) receiving either SII Inactivated Salk Polio Vaccine (Adsorbed) 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. Three doses of either SII Inactivated Salk Polio Vaccine (Adsorbed) or Sii licensed IPV will be administered as a 0.5 mL intramuscular injection in mid-lateral aspect of the thigh, 4 weeks apart (minimum interval of 4 weeks and maximum of 6 weeks), with the first administration given at 6-8 weeks of age.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 648
- 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).
- Presence of fever on the day of enrollment [Temporary exclusion criteria].
- Acute disease at the time of enrollment [Temporary exclusion criteria].
- Prior receipt or intent to receive OPV/IPV/IPV containing vaccines during the study period.
- Presence of significant malnutrition (weight-for-height z-score < -3SD median) 5.
- Known or suspected impairment of immunological function based on medical history and physical examination.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of participants with type-specific seroconversion for SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. 28 days after third vaccination
- Secondary Outcome Measures
Name Time Method Type-specific geometric mean titers of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. Percentage of participants with type-specific seroprotection (titers ≥ 8) of SII Inactivated Salk Polio Vaccine (Adsorbed) and Sii Licensed IPV. Day 28 after the third vaccination
Trial Locations
- Locations (9)
All India Institute of Medical Sciences
🇮🇳Gorakhpur, UTTAR PRADESH, India
Bharati Vidyapeeth Medical College Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Cheluvamba Hospital, Mysore Medical College and Research Institute Mysuru
🇮🇳Mysore, KARNATAKA, India
ICMR-National Institute of Cholera and Enteric Disease (ICMR-NICED)
🇮🇳Kolkata, WEST BENGAL, India
IMS and SUM Hospital, Bhubaneshwar
🇮🇳Khordha, ORISSA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Kurnool Medical College/Govt. Hospital,Kurnool
🇮🇳Kurnool, ANDHRA PRADESH, India
Post Graduate Institute of Medical Education and Research, Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
T N Medical College and B Y L Nair Hospital, Mumbai
🇮🇳Mumbai, MAHARASHTRA, India
All India Institute of Medical Sciences🇮🇳Gorakhpur, UTTAR PRADESH, IndiaDr Hira Lal BhallaPrincipal investigator9761715236hirabhalla@gmail.com