A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00953524

First received: August 3, 2009

Last updated: July 8, 2011

Last verified: July 2011

History of Changes

Results First Received: June 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Influenza Swine-origin A/H1N1 Influenza
Interventions:	Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (7.5 µg of HA) Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (15 µg of HA) Biological: Monovalent Subvirion A/H1N1 Influenza vaccine (30 µg of HA) Biological: Normal saline solution (placebo)

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
Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.

Reporting Groups

	Description
A/H1N1 Vaccine Group 1	Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2	Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 3	Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Placebo Group	Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.

Participant Flow: Overall Study

	A/H1N1 Vaccine Group 1	A/H1N1 Vaccine Group 2	A/H1N1 Vaccine Group 3	Placebo Group
STARTED	249	254	247	99
COMPLETED	227	239	233	91
NOT COMPLETED	22	15	14	8
Adverse Event	2	0	1	2
Protocol Violation	18	10	11	6
Lost to Follow-up	0	1	1	0
Withdrawal by Subject	2	4	1	0

Baseline Characteristics

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Reporting Groups

	Description
A/H1N1 Vaccine Group 1	Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 2	Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
A/H1N1 Vaccine Group 3	Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
Placebo Group	Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
Total	Total of all reporting groups

Baseline Measures

	A/H1N1 Vaccine Group 1	A/H1N1 Vaccine Group 2	A/H1N1 Vaccine Group 3	Placebo Group	Total
Number of Participants [units: participants]	249	254	247	99	849
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	150	152	148	49	499
>=65 years	99	102	99	50	350
Age [units: Years] Mean ± Standard Deviation	52.8 ± 19.2	53.4 ± 18.9	54.4 ± 18.4	56.4 ± 18.1	53.4 ± 18.9
Gender [units: participants]
Female	140	143	145	57	485
Male	109	111	102	42	364
Region of Enrollment [units: participants]
United States	249	254	247	99	849

Outcome Measures

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1. Primary:

Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [ Time Frame: Pre-vaccination (Day 0) and day 21 post-vaccination ]

Show Outcome Measure 1

2. Primary:

Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [ Time Frame: Pre-vaccination (Day 0) and Day 21 post-vaccination ]

Show Outcome Measure 2

3. Primary:

Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

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4. Primary:

Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

Show Outcome Measure 4

5. Primary:

Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

Show Outcome Measure 5

6. Primary:

Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years [ Time Frame: Pre-vaccination (Day 0) and 21 days post-vaccination ]

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7. Primary:

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years [ Time Frame: Days 0 to 7 post-vaccination ]

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8. Primary:

Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years [ Time Frame: Days 0 to 7 post-vaccination ]

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Serious Adverse Events

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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: Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications

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
No text entered.

Results Point of Contact:

Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com

Publications of Results:

Plennevaux E, Sheldon E, Blatter M, Reeves-Hoché MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. Epub 2009 Dec 15.

Responsible Party:	Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT00953524 History of Changes
Other Study ID Numbers:	FUF14, UTN: U1111-1111-4798
Study First Received:	August 3, 2009
Results First Received:	June 8, 2011
Last Updated:	July 8, 2011
Health Authority:	United States: Food and Drug Administration

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