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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

April 26, 2011
August 23, 2012
April 2011
February 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01342796 on ClinicalTrials.gov Archive Site
Seroprotection, GMRs and seroconversion rate at day 0 and day 50 after vaccination [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Seroprotection, GMRs and serocoversionrate at day 0 and day 50 after vaccination [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
  • Seasonal Influenza;
  • Influenza;
  • Influenza Due to Unspecified Influenza Virus
  • Human Influenza
  • 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
  • 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
    Intervention: Biological: MF59C.1-adjuvanted subunit influenza vaccine
  • Active Comparator: Arm 2
    Intervention: Biological: Sub unit, Inactivated, Influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
6 Months to 36 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01342796
V70_34, 2010-023791-63
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP