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NCT Number: NCT01342796

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

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.

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Key information

Conditions

Seasonal Influenza Human Influenza Infections Influenza Influenza Due to Unspecified Influenza Virus Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 21: GZA campus Sint Vincentius, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MF59C.1-adjuvanted subunit influenza vaccine

Biological

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Sub unit, Inactivated, Influenza vaccine

Biological

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Primary outcomes

  1. Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.

    Time frame: 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.

  2. Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV

    Time frame: 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.

Secondary outcomes

  1. Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer

    Time frame: 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%.

  2. Geometric Mean Ratios (GMR)

    Time frame: 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.

  3. Percentage of Subjects With HI Titers >1:40

    Time frame: 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%

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 27, 2011
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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