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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014