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

NCT ID: NCT03169725

Last Updated: 2019-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-06-14

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.

Conditions

Poliomyelitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Test group 1

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

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strain)

Intervention Type: 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 2

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

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strain)

Intervention Type: 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 3

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

Group Type: EXPERIMENTAL

Inactivated Poliomyelitis Vaccine (Sabin strain)

Intervention Type: 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.

Comparator

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

Group Type: ACTIVE_COMPARATOR

Inactivated Poliomyelitis Vaccine (Salk strain)

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 8 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LG Chem

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Institute for Tropical Medicine

Alabang, , Philippines

Mahidol University Faculty of Medicine Siriraj Hospital

Bangkok, , Thailand

Chiang Mai University Maharaj Nakhon Chiang Mai Hospital

Chiang Mai, , Thailand

Countries

Philippines; Thailand

References

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.

Reference Type: DERIVED

PMID: 33351072 (View on PubMed)

Other Identifiers

LG-VCCL001

Identifier Type: -

Identifier Source: org_study_id