Trial record 1 of 1 for:
FUF14
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
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ClinicalTrials.gov Identifier: NCT00953524 |
Recruitment Status :
Completed
First Posted : August 6, 2009
Results First Posted : July 11, 2011
Last Update Posted : March 10, 2014
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, 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) |
Enrollment | 849 |
Participant Flow
Recruitment Details | Participants were enrolled from 06 August 2009 to 07 August 2009 at 15 US clinical centers. |
Pre-assignment Details | A total of 849 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and included in data analysis. |
Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group |
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Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. |
Period Title: Overall Study | ||||
Started | 249 | 254 | 247 | 99 |
Completed | 227 | 239 | 233 | 91 |
Not Completed | 22 | 15 | 14 | 8 |
Reason Not Completed | ||||
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
Arm/Group Title | A/H1N1 Vaccine Group 1 | A/H1N1 Vaccine Group 2 | A/H1N1 Vaccine Group 3 | Placebo Group | Total | |
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Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively. | Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively. | Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively. | Total of all reporting groups | |
Overall Number of Baseline Participants | 249 | 254 | 247 | 99 | 849 | |
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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 | 249 participants | 254 participants | 247 participants | 99 participants | 849 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 |
150 60.2%
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152 59.8%
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148 59.9%
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49 49.5%
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499 58.8%
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>=65 years |
99 39.8%
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102 40.2%
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99 40.1%
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50 50.5%
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350 41.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 249 participants | 254 participants | 247 participants | 99 participants | 849 participants | |
52.8 (19.2) | 53.4 (18.9) | 54.4 (18.4) | 56.4 (18.1) | 53.4 (18.9) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 249 participants | 254 participants | 247 participants | 99 participants | 849 participants | |
Female |
140 56.2%
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143 56.3%
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145 58.7%
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57 57.6%
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485 57.1%
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Male |
109 43.8%
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111 43.7%
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102 41.3%
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42 42.4%
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364 42.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 249 participants | 254 participants | 247 participants | 99 participants | 849 participants |
249 | 254 | 247 | 99 | 849 |
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 |
Responsible Party: | Sanofi ( Sanofi Pasteur, a Sanofi Company ) |
ClinicalTrials.gov Identifier: | NCT00953524 |
Other Study ID Numbers: |
FUF14 UTN: U1111-1111-4798 ( Other Identifier: WHO ) |
First Submitted: | August 3, 2009 |
First Posted: | August 6, 2009 |
Results First Submitted: | June 8, 2011 |
Results First Posted: | July 11, 2011 |
Last Update Posted: | March 10, 2014 |