A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

Phase 2

Completed

• Conditions: Poliomyelitis

• Registration Number: NCT03169725
• Lead Sponsor: LG Chem

Brief Summary

The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-25
• Study First Posted: 2017-05-30
• Study Start: 2017-05-31
• Status Verified: 2019-01
• Primary Completion: 2019-01-18
• Study Completion: 2019-06-14
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1417

Inclusion Criteria

• Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment
• Born at full term of pregnancy (Gestational age ≥37 weeks)
• Body weight ≥ 3.2 kg at the time of screening
• Born to HIV negative mother
• The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
• Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)

Exclusion Criteria

• Previously received any polio vaccines (OPV or IPV)
• History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
• History of bleeding disorder contraindicating intramuscular injection.
• Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
• Receipt of immunoglobulin or blood-derived product since birth
• History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
• Known or suspected immune disorder, or received immunosuppressive therapy
• History of poliomyelitis
• History of any neurological disorders or seizures
• Known or suspected febrile, acute or progressive illness
• Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
• Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
• Infants whose families are planning to leave the area of the study site before the end of the study period
• Infants who is considered unsuitable for the clinical study by the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stage1: Seroconversion rate(%)	4 weeks after 3rd vaccination	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Stage2: Seroconversion rate(%)	4 weeks after 3rd vaccination	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Secondary Outcome Measures

Name	Time	Method
Stage1: GMTs (Geometric Mean Titers)	4 weeks after 2nd and 3rd vaccination	Comparison of GMTs and GMT ratios
Stage1: Seroconversion rate (%)	4 weeks after 2nd vaccination	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Stage2: Seroprotection rate (%)	4 weeks after 3rd vaccination	Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
Stage2: GMTs (Geometric Mean Titers)	4 weeks after 3rd vaccination	Comparison of GMTs and GMT ratios

Trial Locations

Locations (3)

Research Institute for Tropical Medicine; 🇵🇭 Alabang, Philippines

Mahidol University Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkok, Thailand

Chiang Mai University Maharaj Nakhon Chiang Mai Hospital; 🇹🇭 Chiang Mai, Thailand