A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CSL Limited

ClinicalTrials.gov Identifier:

NCT01113580

First received: April 26, 2010

Last updated: June 13, 2012

Last verified: June 2012

History of Changes

Results First Received: June 13, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Influenza
Intervention:	Biological: CSL's 2010/2011 Formulation of Enzira® Vaccine

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Adults	Healthy volunteers aged 18 to 59 years
Older Adults	Healthy volunteers aged 60 years or older

Participant Flow: Overall Study

	Adults	Older Adults
STARTED	60	60
COMPLETED	59	60
NOT COMPLETED	1	0
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
Adults	Healthy volunteers aged 18 to 59 years
Older Adults	Healthy volunteers aged 60 years or older
Total	Total of all reporting groups

Baseline Measures

	Adults	Older Adults	Total
Number of Participants [units: participants]	60	60	120
Age, Customized [units: participants]
< 18 years	0	0	0
18 to 59 years	60	0	60
>= 60 years	0	60	60
Gender [units: participants]
Female	29	24	53
Male	31	36	67

Outcome Measures

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1. Primary:

The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre. [ Time Frame: Approximately 21 days after vaccination ]

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2. Primary:

The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination. [ Time Frame: Approximately 21 days after vaccination ]

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3. Primary:

The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2. [ Time Frame: Approximately 21 days after vaccination ]

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4. Secondary:

Frequency of Any Solicited Adverse Events (AEs) [ Time Frame: During the 4 days after vaccination (Day 0 plus 3 days) ]

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5. Secondary:

Frequency and Intensity of Any Unsolicited Adverse Events [ Time Frame: After vaccination until the end of the study; approximately 21 days ]

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Serious Adverse Events

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Time Frame	Approximately 21 days after study vaccination for serious adverse events and unsolicited adverse events.
Additional Description	Other adverse events presented were unsolicited adverse events up to approximately 21 days after study vaccination.

Reporting Groups

	Description
Adults	Healthy volunteers aged 18 to 59 years
Older Adults	Healthy volunteers aged 60 years or older

Serious Adverse Events

	Adults	Older Adults
Total, serious adverse events
# participants affected / at risk	0/60 (0.00%)	0/60 (0.00%)

Other Adverse Events

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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: CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Limited
phone: Use email contact
e-mail: csl.clinicaltrials@csl.com.au

No publications provided

Responsible Party:	CSL Limited
ClinicalTrials.gov Identifier:	NCT01113580 History of Changes
Other Study ID Numbers:	CSLCT-ASU-10-66, 2010-019532-12
Study First Received:	April 26, 2010
Results First Received:	June 13, 2012
Last Updated:	June 13, 2012
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

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