Phase 2
Completed N=84
Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects
Seasonal Influenza · Influenza · Influenza Due to Unspecified Influenza Virus · Human Influenza
Source: ClinicalTrials.gov NCT01342796 ↗
Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Apr 2021
Primary outcomePrimary: Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. — 631; 655; 1560; 1137 Cells per Million Total Cells
Summary
This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. |
631; 655; 1560; 1137; 503; 462 | — |
| PRIMARY Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV |
20; 18; 1; 3; 0; 2 | — |
| SECONDARY Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer |
100; 73; 100; 93; 100; 53 | — |
| SECONDARY Geometric Mean Ratios (GMR) |
41; 9.99; 199; 35; 34; 5.63 | — |
| SECONDARY Percentage of Subjects With HI Titers >1:40 |
100; 93; 100; 97; 100; 57 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female previously unvaccinated healthy children aged 6 to <36 months.
Exclusion Criteria
- Any known or suspected impairment of the immune system, any serious disease.
- Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
- Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.
Data sourced from ClinicalTrials.gov (NCT01342796). 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.