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

Poliomyelitis Clinical Trial

Official title:

A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03169725
• Other study ID #: LG-VCCL001
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 31, 2017
• Est. completion date: June 14, 2019

Study information

• Verified date: January 2019
• Source: LG Chem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1417
• Est. completion date: June 14, 2019
• Est. primary completion date: January 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Weeks to 8 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Biological:
• Inactivated Poliomyelitis Vaccine (Sabin strain)
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
• Inactivated Poliomyelitis Vaccine (Salk strain)
Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.

Locations

Country	Name	City	State
Philippines	Research Institute for Tropical Medicine	Alabang
Thailand	Mahidol University Faculty of Medicine Siriraj Hospital	Bangkok
Thailand	Chiang Mai University Maharaj Nakhon Chiang Mai Hospital	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
LG Chem

Countries where clinical trial is conducted

Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage1: Seroconversion rate(%)	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay	4 weeks after 3rd vaccination
Primary	Stage2: Seroconversion rate(%)	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay	4 weeks after 3rd vaccination
Secondary	Stage1: Seroconversion rate (%)	Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay	4 weeks after 2nd vaccination
Secondary	Stage2: Seroprotection rate (%)	Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay	4 weeks after 3rd vaccination
Secondary	Stage1: GMTs (Geometric Mean Titers)	Comparison of GMTs and GMT ratios	4 weeks after 2nd and 3rd vaccination
Secondary	Stage2: GMTs (Geometric Mean Titers)	Comparison of GMTs and GMT ratios	4 weeks after 3rd vaccination