Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

This study has been completed.

Sponsor:

Collaborator:

Novartis Vaccines

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00956761

First received: August 8, 2009

Last updated: December 21, 2015

Last verified: December 2015

History of Changes

Results First Received: December 21, 2015

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Seasonal Influenza
Intervention:	Biological: Seasonal Influenza Vaccine (MF59C.1)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall, 63 participants ≥65 years of age were enrolled at 2 sites in Italy.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Blood samples for the determination of antibody titers were drawn on Day 0 prior to vaccination.

Reporting Groups

	Description
FLUAD	Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.

Participant Flow: Overall Study

	FLUAD
STARTED	63
COMPLETED	63
NOT COMPLETED	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline analysis population was defined as all participants who were enrolled.

Reporting Groups

	Description
FLUAD	Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.

Baseline Measures

	FLUAD
Number of Participants [units: participants]	63
Age [units: Years] Mean (Standard Deviation)	72.9 (6.0)
Gender [units: Participants]
Female	27
Male	36

Outcome Measures

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1. Primary:

Percentage of Participants Who Achieved Seroconversion or Significant Increase in Single Radial Hemolysis (SRH) Area Against Each of Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: Day 21 ]

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2. Primary:

Geometric Mean Ratio of Participants Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ]

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3. Primary:

Percentage of Participants Who Achieved SRH Area ≥25mm2 Against Each of the Three Vaccine Strains After One Vaccination of FLUAD [ Time Frame: day 21 ]

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4. Primary:

Number of Participants Who Reported Solicited Local and Systemic Reactions [ Time Frame: 0-3 days post-vaccination ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.

Results Point of Contact:

Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics S.r.l
e-mail: RegistryContactVaccinesUS@novartis.com

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00956761 History of Changes
Other Study ID Numbers:	V70_09S 2009-010586-23
Study First Received:	August 8, 2009
Results First Received:	December 21, 2015
Last Updated:	December 21, 2015
Health Authority:	Italy: EMEA

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