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

A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

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 Overview

• Status: Completed
• Conditions: Influenza; Seasonal Influenza; Human Influenza; Influenza Due to Unspecified Influenza Virus
• Intervention / Treatment: Biological: MF59C.1-adjuvanted subunit influenza vaccine; Biological: Sub unit, Inactivated, Influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2018
    • Site 21: GZA campus Sint Vincentius
  • Hasselt, Belgium, 3500
    • Site 22: Kinderartsenpraktijk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Biological: Sub unit, Inactivated, Influenza vaccine; 2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Experimental: Arm 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Zedda L, Forleo-Neto E, Vertruyen A, Raes M, Marchant A, Jansen W, Clouting H, Arora A, Beatty ME, Galli G, Del Giudice G, Castellino F. Dissecting the immune response to MF59-adjuvanted and nonadjuvanted seasonal influenza vaccines in children less than three years of age. Pediatr Infect Dis J. 2015 Jan;34(1):73-8. doi: 10.1097/INF.0000000000000465.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: April 26, 2011
• First Submitted That Met QC Criteria: April 26, 2011
• First Posted (Estimate): April 27, 2011

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Children; Cell mediated immunity; cell mediated immune response; adjuvanted
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V70_34; 2010-023791-63 (EudraCT Number)