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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01342796
Other study ID # V70_34
Secondary ID 2010-023791-63
Status Completed
Phase Phase 2
First received
Last updated
Start date May 2011
Est. completion date February 2012

Study information

Verified date February 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Months to 36 Months
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
MF59C.1-adjuvanted subunit influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Sub unit, Inactivated, Influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Locations

Country Name City State
Belgium Site 21: GZA campus Sint Vincentius Antwerpen
Belgium Site 22: Kinderartsenpraktijk Hasselt

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. 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. Day 1, Day 50
Primary Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV 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. Day 1 to Day 50 post vaccination
Secondary Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer 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%.
Day 50
Secondary Geometric Mean Ratios (GMR) 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.
Day 50/Day 1
Secondary Percentage of Subjects With HI Titers >1:40 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%
Day 50
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