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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

Primary Purpose

Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
MF59C.1-adjuvanted subunit influenza vaccine
Sub unit, Inactivated, Influenza vaccine
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Seasonal Influenza focused on measuring Cell mediated immunity, cell mediated immune response, Children, adjuvanted

Eligibility Criteria

6 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Site 21: GZA campus Sint Vincentius
  • Site 22: Kinderartsenpraktijk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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%.
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.
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%

Full Information

First Posted
April 26, 2011
Last Updated
April 14, 2021
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01342796
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Human Influenza
Keywords
Cell mediated immunity, cell mediated immune response, Children, adjuvanted

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
MF59C.1-adjuvanted subunit influenza vaccine
Intervention Description
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Intervention Type
Biological
Intervention Name(s)
Sub unit, Inactivated, Influenza vaccine
Intervention Description
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
Primary Outcome Measure Information:
Title
Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.
Description
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
Title
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
Description
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 Outcome Measure Information:
Title
Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer
Description
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
Title
Geometric Mean Ratios (GMR)
Description
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
Title
Percentage of Subjects With HI Titers >1:40
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Site 21: GZA campus Sint Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
Site 22: Kinderartsenpraktijk
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
25037034
Citation
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.
Results Reference
derived

Learn more about this trial

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

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