Phase 3
N=773
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Poliomyelitis
Bottom Line
View on ClinicalTrials.gov: NCT03239496 ↗Enrolled (actual)
773
Serious AEs
5.0%
Results posted
Aug 2020
Primary outcome: Primary: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM — 98.1; 95.9; 98.7; 97.9 percentage of seroconversion — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IPV (Biological); f-IPV (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Fidec Corporation
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM |
98.1; 95.9; 98.7; 97.9 | 0.05 |
| PRIMARY Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM |
100; 98.1; 100; 98.7 | 0.05 |
| PRIMARY Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID |
98.8; 95.9; 100; 97.9 | 0.05 |
| SECONDARY Seroconversion Superiority of 2 Doses IPV IM at Different Schedules |
95.6; 98.1; 88.9; 98.7 | 0.0001 sig |
| SECONDARY Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules |
83.2; 95.9; 83.9; 97.9 | 0.0001 sig |
| SECONDARY Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM |
100; 95.9; 100; 97.9 | 0.05 |
| SECONDARY Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM |
100; 98.8; 100; 100 | 0.05 |
| SECONDARY Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM |
98.1; 98.8; 98.7; 100 | 0.05 |
| SECONDARY Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions |
10; 6; 7; 9; 4; 0 | — |
Summary
The study will assess and compare the immune response to full-dose inactivated polio vaccines (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule combinations in the Expanded Program on Immunization (EPI) primary series.
Eligibility Criteria
Inclusion Criteria
- Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.
- Healthy, as assessed from medical history and physical examination by a study physician,
- 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
- Vaccinated with any poliovirus vaccine prior to inclusion,
- A household contact with OPV vaccination history in the past 4 weeks,
- HIV infection or pharmacologic immunosuppression,
- Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),
- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections,
- Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be a contraindication for vaccination,
- Not suitable for inclusion or is unlikely to comply with the protocol in the opinion of the investigator(s).
Data sourced from ClinicalTrials.gov (NCT03239496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.