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

LG Chem

Status and phase: Completed; Phase 3; Phase 2

Conditions: Poliomyelitis

Treatments: Biological: Inactivated Poliomyelitis Vaccine (Salk strain); Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03169725

LG-VCCL001

Details and patient eligibility

About

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.

Enrollment: 1,417 patients

Sex: All

Ages: 6 to 8 weeks old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,417 participants in 4 patient groups

Test group 1

Experimental group

Description:

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

Treatment:

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Test group 2

Experimental group

Description:

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

Treatment:

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Test group 3

Experimental group

Description:

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

Treatment:

Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)

Comparator

Active Comparator group

Description:

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

Treatment:

Biological: Inactivated Poliomyelitis Vaccine (Salk strain)