Clinical trial NCT03169725: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Poliomyelitis
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2017-05-30
Enrollment: 1417
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Stage1: Seroconversion rate(%)
timeFrame: 4 weeks after 3rd vaccination
measure: Stage2: Seroconversion rate(%)
timeFrame: 4 weeks after 3rd vaccination
Secondary outcomes:
measure: Stage1: Seroconversion rate (%)
timeFrame: 4 weeks after 2nd vaccination
measure: Stage2: Seroprotection rate (%)
timeFrame: 4 weeks after 3rd vaccination
measure: Stage1: GMTs (Geometric Mean Titers)
timeFrame: 4 weeks after 2nd and 3rd vaccination
measure: Stage2: GMTs (Geometric Mean Titers)
timeFrame: 4 weeks after 3rd vaccination
Other outcomes:
Locations:
city: Alabang
country: Philippines
facility: Research Institute for Tropical Medicine
city: Bangkok
country: Thailand
facility: Mahidol University Faculty of Medicine Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University Maharaj Nakhon Chiang Mai Hospital
Study officials:
References:
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.