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

Tracking Information
First Received Date ^ICMJE	April 26, 2011
Last Updated Date	August 23, 2012
Start Date ^ICMJE	April 2011
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 26, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01342796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 23, 2012)	Seroprotection, GMRs and seroconversion rate at day 0 and day 50 after vaccination [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: April 26, 2011)	Seroprotection, GMRs and serocoversionrate at day 0 and day 50 after vaccination [ Time Frame: 50 days ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Seasonal Influenza; Influenza; Influenza Due to Unspecified Influenza Virus Human Influenza
Intervention ^ICMJE	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
Study Arm (s)	Experimental: Arm 1 Intervention: Biological: MF59C.1-adjuvanted subunit influenza vaccine Active Comparator: Arm 2 Intervention: Biological: Sub unit, Inactivated, Influenza vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	84
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	6 Months to 36 Months
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium

Administrative Information
NCT Number ^ICMJE	NCT01342796
Other Study ID Numbers ^ICMJE	V70_34, 2010-023791-63
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ^ICMJE	Novartis Vaccines
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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