Phase 3
Completed N=773
A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Source: ClinicalTrials.gov NCT03239496 ↗Enrolled (actual)
773
Serious AEs
5.0%
Results posted
Aug 2020
Primary outcomePrimary: 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
◆ Published Evidence
Established
31citations · ~6 / year
Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: a randomised open-label, multicentre, phase 3, non-inferiority trial.
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.
Linked Publications
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Safety and immunogenicity of inactivated poliovirus vaccine schedules for the post-eradication era: a randomised open-label, multicentre, phase 3, non-inferiority trial.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.