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Completed

NCT Number: NCT03169725

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

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.

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Key information

Age range

6 week–8 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Research Institute for Tropical Medicine, Alabang, Philippines

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Stage1: Seroconversion rate(%)

    Time frame: 4 weeks after 3rd vaccination

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

  2. Stage2: Seroconversion rate(%)

    Time frame: 4 weeks after 3rd vaccination

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

Secondary outcomes

  1. Stage1: Seroconversion rate (%)

    Time frame: 4 weeks after 2nd vaccination

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

  2. Stage2: Seroprotection rate (%)

    Time frame: 4 weeks after 3rd vaccination

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

  3. Stage1: GMTs (Geometric Mean Titers)

    Time frame: 4 weeks after 2nd and 3rd vaccination

    Comparison of GMTs and GMT ratios

  4. Stage2: GMTs (Geometric Mean Titers)

    Time frame: 4 weeks after 3rd vaccination

    Comparison of GMTs and GMT ratios

Sponsors and collaborators

Lead sponsor

LG Chem

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 30, 2017
Registry last updated
Aug 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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