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
NCT ID: NCT03566940
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
302 participants
INTERVENTIONAL
2018-07-31
2019-10-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
DOUBLE
Study Groups
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Group 1: Low Dose IPV Based on Sabin Strains (sIPV)
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).
sIPV
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Group 2: Intermediate Dose sIPV
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).
sIPV
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Group 3: High Dose sIPV
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).
sIPV
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Group 4: Conventional Salk IPV (cIPV)
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).
cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Interventions
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sIPV
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPV
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
39 Days
59 Days
ALL
Yes
Sponsors
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Janssen Vaccines & Prevention B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Vaccines & Prevention B.V. Clinical Trial
Role: STUDY_DIRECTOR
Janssen Vaccines & Prevention B.V.
Locations
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De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, , Philippines
De La Salle University Medical Center
Dasmariñas, , Philippines
Philippine General Hospital
Manila, , Philippines
Countries
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Other Identifiers
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GV000051POL2001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108472
Identifier Type: -
Identifier Source: org_study_id
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