Phase 2
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
Bottom Line
View on ClinicalTrials.gov: NCT01342796 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Apr 2021
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MF59C.1-adjuvanted subunit influenza vaccine (Biological); Sub unit, Inactivated, Influenza vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Feb 2012
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 | — |
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.
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.