A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Biological: sIPV; Biological: cIPV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03566940

CR108472

GV000051POL2001 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.

Enrollment: 302 patients

Sex: All

Ages: 39 to 59 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
• Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)
• Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
• Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window

Exclusion criteria

• Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
• Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
• Received polio vaccine or were previously infected with poliovirus
• Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
• Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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302 participants in 4 patient groups

Group 1: Low Dose IPV Based on Sabin Strains (sIPV)

Experimental group

Description:

Participants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age).

Treatment:

Biological: cIPV

Biological: sIPV

Group 2: Intermediate Dose sIPV

Experimental group

Description:

Participants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).

Treatment:

Biological: cIPV

Biological: sIPV

Group 3: High Dose sIPV

Experimental group

Description:

Participants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).

Treatment:

Biological: cIPV

Biological: sIPV

Group 4: Conventional Salk IPV (cIPV)

Active Comparator group

Description:

Participants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age).

Treatment:

Biological: cIPV