NCT03169725

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,417

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 31, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed
Last Updated

August 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

May 11, 2017

Last Update Submit

August 27, 2019

Conditions

Poliomyelitis

Outcome Measures

Primary Outcomes (2)

  • Stage1: Seroconversion rate(%)

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

    4 weeks after 3rd vaccination

  • Stage2: Seroconversion rate(%)

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

    4 weeks after 3rd vaccination

Secondary Outcomes (4)

  • Stage1: Seroconversion rate (%)

    4 weeks after 2nd vaccination

  • Stage2: Seroprotection rate (%)

    4 weeks after 3rd vaccination

  • Stage1: GMTs (Geometric Mean Titers)

    4 weeks after 2nd and 3rd vaccination

  • Stage2: GMTs (Geometric Mean Titers)

    4 weeks after 3rd vaccination

Study Arms (4)

Test group 1

EXPERIMENTAL

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

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Test group 2

EXPERIMENTAL

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

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Test group 3

EXPERIMENTAL

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

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Comparator

ACTIVE COMPARATOR

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

Biological: Inactivated Poliomyelitis Vaccine (Salk strain)

Interventions

Inactivated Poliomyelitis Vaccine (Sabin strain)BIOLOGICAL

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.

Test group 1Test group 2Test group 3
Inactivated Poliomyelitis Vaccine (Salk strain)BIOLOGICAL

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.

Comparator

Eligibility Criteria

Age6 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Institute for Tropical Medicine

Alabang, Philippines

Location

Mahidol University Faculty of Medicine Siriraj Hospital

Bangkok, Thailand

Location

Chiang Mai University Maharaj Nakhon Chiang Mai Hospital

Chiang Mai, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 33351072DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines, InactivatedVaccinesBiological ProductsComplex MixturesPoliovirus VaccinesViral Vaccines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 30, 2017

Study Start

May 31, 2017

Primary Completion

January 18, 2019

Study Completion

June 14, 2019

Last Updated

August 29, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(2)PH(1)