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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00952276

First received: August 3, 2009

Last updated: August 26, 2011

Last verified: August 2011

History of Changes

Results First Received: August 26, 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 with adjuvant Biological: Monovalent Subvirion A/H1N1 influenza vaccine Biological: Normal saline solution

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 29 October 2009 to 13 November 2009 at 14 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 548 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis.

Reporting Groups

	Description
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Group 3: A/H1N1 Vaccine Formulation 3	Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Group 4: A/H1N1 Vaccine Formulation 4	Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Group 5: Placebo	Participants who received a dose of placebo (normal saline) on Day 0

Participant Flow: Overall Study

	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	Group 3: A/H1N1 Vaccine Formulation 3	Group 4: A/H1N1 Vaccine Formulation 4	Group 5: Placebo
STARTED	127	115	122	121	63
COMPLETED	126	115	122	120	63
NOT COMPLETED	1	0	0	1	0
Withdrawal by Subject	1	0	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
Group 3: A/H1N1 Vaccine Formulation 3	Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
Group 4: A/H1N1 Vaccine Formulation 4	Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
Group 5: Placebo	Participants who received a dose of placebo (normal saline) on Day 0
Total	Total of all reporting groups

Baseline Measures

	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	Group 3: A/H1N1 Vaccine Formulation 3	Group 4: A/H1N1 Vaccine Formulation 4	Group 5: Placebo	Total
Number of Participants [units: participants]	127	115	122	121	63	548
Age [units: participants]
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	75	69	73	71	38	326
>=65 years	52	46	49	50	25	222
Age [units: Years] Mean ± Standard Deviation
Age Continuous	54.0 ± 18.4	53.3 ± 18.7	51.9 ± 18.0	52.7 ± 19.9	54.7 ± 16.7	53.4 ± 18.34
Gender [units: participants]
Female	79	65	66	68	45	323
Male	48	50	56	53	18	225
Region of Enrollment [units: Participants]
United States	127	115	122	121	63	548

Outcome Measures

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1. Primary:

Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

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2. Primary:

Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

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3. Primary:

Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

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4. Primary:

Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

Show Outcome Measure 4

5. Primary:

Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

Show Outcome Measure 5

6. Primary:

Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 and Day 21 post-vaccination ]

Show Outcome Measure 6

7. Primary:

Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years [ Time Frame: Day 0 up to Day 7 post-vaccination ]

Show Outcome Measure 7

8. Primary:

Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years [ Time Frame: Day 0 up to Day 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

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT00952276 History of Changes
Other Study ID Numbers:	FUF16, UTN: U1111-1111-4882
Study First Received:	August 3, 2009
Results First Received:	August 26, 2011
Last Updated:	August 26, 2011
Health Authority:	United States: Food and Drug Administration

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