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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01342796
First received: April 26, 2011
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Seasonal Influenza;
Influenza;
Influenza Due to Unspecified Influenza Virus
Human Influenza
 Biological: MF59C.1-adjuvanted subunit influenza vaccine
Biological: Sub unit, Inactivated, Influenza vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Cell mediated immune (CMI) responses as determined by the quality and quantity of the antigen-specific T- cells responses after in-vitro restimulation of peripheral blood mononuclear cells at day 0 and day 50 following vaccination.Safety and tolerability [ Time Frame: 50 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seroprotection, GMRs and seroconversion rate at day 0 and day 50 after vaccination [ Time Frame: 50 days ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: April 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342796

Locations
Belgium
Site 21: GZA campus Sint Vincentius
Sint Vincentiusstraat 20, Antwerpen, Belgium, 2018
Site 22: Kinderartsenpraktijk
Stadsomvaart 5, Hasselt, Belgium, 3500
Sponsors and Collaborators
Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01342796     History of Changes
Other Study ID Numbers: V70_34, 2010-023791-63
Study First Received: April 26, 2011
Last Updated: August 23, 2012
Health Authority: Belgium: The Federal Agency for Medicines and Health Products (FAMHP)

Keywords provided by Novartis:
Cell mediated immunity
cell mediated immune response
Children
adjuvanted

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013