A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV

• Register: ClinicalTrials.gov
• Last refreshed on: 25 July 2023
• Main ID: NCT03239496
• Date of registration: 28/07/2017
• Prospective Registration: Yes
• Primary sponsor: Fidec Corporation
• Public title: A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
• Scientific title: A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants
• Date of first enrolment: October 23, 2017
• Target sample size: 773
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03239496
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Dominican Republic, Panama

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.

2. Healthy, as assessed from medical history and physical examination by a study
physician,

3. Written informed consent obtained from parents or legal representatives who have been
properly informed about the study and are able to comply with planned study
procedures.

Exclusion Criteria:

1. Vaccinated with any poliovirus vaccine prior to inclusion,

2. A household contact with OPV vaccination history in the past 4 weeks,

3. HIV infection or pharmacologic immunosuppression,

4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),

5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and
intradermal injections,

6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be
a contraindication for vaccination,

7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion
of the investigator(s).



Age minimum: 5 Weeks
Age maximum: 7 Weeks
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Biological: f-IPV

Biological: IPV

Primary Outcome(s)

Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM [Time Frame: To be assessed 4 weeks after the last dose]

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM [Time Frame: To be assessed 4 weeks after the last dose]

Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID [Time Frame: To be assessed 4 weeks after the last dose]

Secondary Outcome(s)

Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM [Time Frame: To be assessed 4 weeks after the last dose]

Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM [Time Frame: To be assessed 4 weeks after the last dose]

Seroconversion Superiority of 2 Doses IPV IM at Different Schedules [Time Frame: To be assessed 4 weeks after the second dose]

Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules [Time Frame: To be assessed 4 weeks after the second dose]

Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions [Time Frame: 9 months]

Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM [Time Frame: To be assessed 4 weeks after the last dose]

Secondary ID(s)

IPV004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bill and Melinda Gates Foundation

Results

• Results available: Yes
• Date Posted: 18/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03239496