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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03566940
• Date of registration: 12/06/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Vaccines & Prevention B.V.
• Public title: 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
• Scientific title: A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines
• Date of first enrolment: July 31, 2018
• Target sample size: 302
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03566940
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Philippines, Thailand

Contacts

• Name: Janssen Vaccines & Prevention B.V. Clinical Trial
• Affiliation: Janssen Vaccines & Prevention B.V.

Key inclusion & exclusion criteria

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)



Age minimum: 39 Days
Age maximum: 59 Days
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Biological: cIPV

Biological: sIPV

Primary Outcome(s)

Number of Participants with Solicited Local and Systemic Adverse Events (AEs) [Time Frame: 7 days after first vaccination]

Number of Participants with Solicited Local and Systemic AEs [Time Frame: 7 days after third vaccination]

Number of Participants with Unsolicited AEs [Time Frame: 28 days after first vaccination]

Number of Participants Discontinued due to AEs [Time Frame: Approximately up to 36 weeks]

Number of Participants with Serious Adverse Events (SAEs) [Time Frame: Approximately up to 36 weeks]

Number of Participants with Solicited Local and Systemic AEs [Time Frame: 7 days after second vaccination]

Number of Participants with Unsolicited AEs [Time Frame: 28 days after third vaccination]

Number of Participants with Unsolicited AEs [Time Frame: 28 days after second vaccination]

Secondary Outcome(s)

Percentage of Participants with Seroprotection [Time Frame: 28 days after the third vaccination]

Percentage of Participants with Seroconversion [Time Frame: 28 days after the third vaccination]

Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses [Time Frame: 28 days after the third vaccination]

Secondary ID(s)

GV000051POL2001

CR108472

Source(s) of Monetary Support

Please refer to primary and secondary sponsors