Trial record 1 of 1 for:
H-261-001
Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00819013 |
Recruitment Status :
Completed
First Posted : January 8, 2009
Results First Posted : January 16, 2012
Last Update Posted : January 19, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention |
Condition |
Influenza |
Interventions |
Biological: Influenza A Vaccine: ACAM FLU-A Biological: Saline placebo |
Enrollment | 87 |
Participant Flow
Recruitment Details | Participants were enrolled from 11 to 27 July 2007 at 3 clinical centers in the US. |
Pre-assignment Details | A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
Arm/Group Title | ACAM-FLU-A Adjuvanted With Alhydrogel | ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | ACAM FLU A Without Adjuvant | Saline Placebo |
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Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. | Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. | Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. |
Period Title: Overall Study | ||||
Started | 22 | 23 | 21 | 21 |
Completed | 19 | 22 | 16 | 17 |
Not Completed | 3 | 1 | 5 | 4 |
Reason Not Completed | ||||
Not meeting continuing study eligibility | 2 | 1 | 2 | 1 |
Adverse Event | 0 | 0 | 1 | 0 |
Withdrawal by Subject | 1 | 0 | 1 | 0 |
Lost to Follow-up | 0 | 0 | 1 | 2 |
Death | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | ACAM-FLU-A Adjuvanted With Alhydrogel | ACAM-FLU-A Adjuvanted With Stimulon® QS-21 | ACAM FLU A Without Adjuvant | Saline Placebo | Total | |
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Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30. | Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30. | Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30. | Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30. | Total of all reporting groups | |
Overall Number of Baseline Participants | 22 | 23 | 21 | 21 | 87 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 22 participants | 23 participants | 21 participants | 21 participants | 87 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
22 100.0%
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23 100.0%
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21 100.0%
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21 100.0%
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87 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 22 participants | 23 participants | 21 participants | 21 participants | 87 participants | |
29.1 (5.91) | 27.7 (4.96) | 27.9 (6.76) | 29.4 (6.84) | 28.5 (6.1175) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 22 participants | 23 participants | 21 participants | 21 participants | 87 participants | |
Female |
7 31.8%
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12 52.2%
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10 47.6%
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10 47.6%
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39 44.8%
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Male |
15 68.2%
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11 47.8%
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11 52.4%
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11 52.4%
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48 55.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 22 participants | 23 participants | 21 participants | 21 participants | 87 participants |
22 | 23 | 21 | 21 | 87 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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.
Results Point of Contact
Name/Title: | Medical Director |
Organization: | Sanofi Pasteur Inc. |
EMail: | RegistryContactUs@sanofipasteur.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00819013 |
Other Study ID Numbers: |
H-261-001 |
First Submitted: | October 10, 2008 |
First Posted: | January 8, 2009 |
Results First Submitted: | November 1, 2011 |
Results First Posted: | January 16, 2012 |
Last Update Posted: | January 19, 2012 |