Back to results

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

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Inactivated Poliomyelitis Vaccine (Sabin strain)

Inactivated Poliomyelitis Vaccine (Salk strain)

About this trial

This is an interventional prevention trial for Poliomyelitis

Eligibility Criteria

6 Weeks - 8 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Research Institute for Tropical Medicine
Mahidol University Faculty of Medicine Siriraj Hospital
Chiang Mai University Maharaj Nakhon Chiang Mai Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Test group 1

Test group 2

Test group 3

Comparator

Arm Description

Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio)

Outcomes

Primary Outcome Measures

Stage1: Seroconversion rate(%)

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Stage2: Seroconversion rate(%)

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Secondary Outcome Measures

Stage1: Seroconversion rate (%)

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Stage2: Seroprotection rate (%)

Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay

Stage1: GMTs (Geometric Mean Titers)

Comparison of GMTs and GMT ratios

Stage2: GMTs (Geometric Mean Titers)

Comparison of GMTs and GMT ratios

Full Information

NCT ID

NCT03169725

First Posted

May 11, 2017

Last Updated

August 27, 2019

Sponsor

LG Chem

1. Study Identification

Unique Protocol Identification Number

NCT03169725

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

May 31, 2017 (Actual)

Primary Completion Date

January 18, 2019 (Actual)

Study Completion Date

June 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LG Chem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1417 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group 1

Arm Type

Experimental

Arm Description

Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

Arm Title

Test group 2

Arm Type

Experimental

Arm Description

Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

Arm Title

Test group 3

Arm Type

Experimental

Arm Description

High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC)

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio)

Intervention Type

Biological

Intervention Name(s)

Inactivated Poliomyelitis Vaccine (Sabin strain)

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Inactivated Poliomyelitis Vaccine (Salk strain)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Stage1: Seroconversion rate(%)

Description

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Time Frame

4 weeks after 3rd vaccination

Title

Stage2: Seroconversion rate(%)

Description

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Time Frame

4 weeks after 3rd vaccination

Secondary Outcome Measure Information:

Title

Stage1: Seroconversion rate (%)

Description

Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay

Time Frame

4 weeks after 2nd vaccination

Title

Stage2: Seroprotection rate (%)

Description

Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay

Time Frame

4 weeks after 3rd vaccination

Title

Stage1: GMTs (Geometric Mean Titers)

Description

Comparison of GMTs and GMT ratios

Time Frame

4 weeks after 2nd and 3rd vaccination

Title

Stage2: GMTs (Geometric Mean Titers)

Description

Comparison of GMTs and GMT ratios

Time Frame

4 weeks after 3rd vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Weeks

Maximum Age & Unit of Time

8 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Research Institute for Tropical Medicine

City

Alabang

Country

Philippines

Facility Name

Mahidol University Faculty of Medicine Siriraj Hospital

City

Bangkok

Country

Thailand

Facility Name

Chiang Mai University Maharaj Nakhon Chiang Mai Hospital

City

Chiang Mai

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33351072

Citation

Capeding MR, Gomez-Go GD, Oberdorfer P, Borja-Tabora C, Bravo L, Carlos J, Tangsathapornpong A, Uppala R, Laoprasopwattana K, Yang Y, Han S, Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs