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

Novartis Vaccines84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Seasonal Influenza Influenza Influenza Due to Unspecified Influenza Virus Human Influenza

Interventions

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 36 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Site 21: GZA campus Sint Vincentius

Antwerp, Belgium

Site 22: Kinderartsenpraktijk

Hasselt, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Day 1, Day 50

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.

Time frame: Day 1 to Day 50 post vaccination

Secondary Outcomes

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%.

Time frame: Day 50

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.

Time frame: Day 50/Day 1

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%

Time frame: Day 50