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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:
ClinicalTrials.gov Identifier:
NCT01342796
First Posted: April 27, 2011
Last Update Posted: August 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


Further study details as provided by Novartis ( Novartis Vaccines ):

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 ]

Secondary Outcome Measures:
  • Seroprotection, GMRs and seroconversion rate at day 0 and day 50 after vaccination [ Time Frame: 50 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01342796     History of Changes
Other Study ID Numbers: V70_34
2010-023791-63 ( EudraCT Number )
First Submitted: April 26, 2011
First Posted: April 27, 2011
Last Update Posted: August 30, 2012
Last Verified: August 2012

Keywords provided by Novartis ( Novartis Vaccines ):
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
Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic