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
- Conditions
- Seasonal InfluenzaHuman InfluenzaInfluenzaInfluenza Due to Unspecified Influenza Virus
- Interventions
- Biological: MF59C.1-adjuvanted subunit influenza vaccineBiological: Sub unit, Inactivated, Influenza vaccine
- Registration Number
- NCT01342796
- Lead Sponsor
- Novartis Vaccines
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Male and female previously unvaccinated healthy children aged 6 to <36 months.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 MF59C.1-adjuvanted subunit influenza vaccine - Arm 2 Sub unit, Inactivated, Influenza vaccine -
- Primary Outcome Measures
Name Time Method Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV Day 1 to Day 50 post vaccination The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.
Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. Day 1, Day 50 The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer Day 50 To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains.
Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be \> 40%.Geometric Mean Ratios (GMR) Day 50/Day 1 To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains.
Criterion: Mean geometric increase (GMR) should be \> 2.5.Percentage of Subjects With HI Titers >1:40 Day 50 To evaluate the immune responses by proportion of subjects with HI titers \>1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to \< 36 months for all three strains.
Criterion: The proportion of subjects with HI titers \>1:40 should be \> 70%
Trial Locations
- Locations (2)
Site 21: GZA campus Sint Vincentius
🇧🇪Antwerpen, Belgium
Site 22: Kinderartsenpraktijk
🇧🇪Hasselt, Belgium