Trial record 2 of 6025 for:    M2e

Safety Study of Recombinant M2e Influenza-A Vaccine in Healthy Adults (FLU-A)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00819013
First received: October 10, 2008
Last updated: January 16, 2012
Last verified: January 2012
Results First Received: November 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Influenza A Vaccine: ACAM FLU-A
Biological: Saline 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 11 to 27 July 2007 at 3 clinical centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 87 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
ACAM-FLU-A Adjuvanted With Alhydrogel Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
ACAM-FLU-A Adjuvanted With Stimulon® QS-21 Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
ACAM FLU A Without Adjuvant Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Saline Placebo Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.

Participant Flow:   Overall Study
    ACAM-FLU-A Adjuvanted With Alhydrogel     ACAM-FLU-A Adjuvanted With Stimulon® QS-21     ACAM FLU A Without Adjuvant     Saline Placebo  
STARTED     22     23     21     21  
COMPLETED     19     22     16     17  
NOT COMPLETED     3     1     5     4  
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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ACAM-FLU-A Adjuvanted With Alhydrogel Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
ACAM-FLU-A Adjuvanted With Stimulon® QS-21 Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
ACAM FLU A Without Adjuvant Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
Saline Placebo Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
Total Total of all reporting groups

Baseline Measures
    ACAM-FLU-A Adjuvanted With Alhydrogel     ACAM-FLU-A Adjuvanted With Stimulon® QS-21     ACAM FLU A Without Adjuvant     Saline Placebo     Total  
Number of Participants  
[units: participants]
  22     23     21     21     87  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     22     23     21     21     87  
>=65 years     0     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation
  29.1  ± 5.91     27.7  ± 4.96     27.9  ± 6.76     29.4  ± 6.84     28.5  ± 6.1175  
Gender  
[units: Participants]
         
Female     7     12     10     10     39  
Male     15     11     11     11     48  
Region of Enrollment  
[units: Participants]
         
United States     22     23     21     21     87  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting Adverse Events by System Organ Class After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.   [ Time Frame: Day 0 through Day 60 post-vaccination ]

2.  Primary:   Number of Participants Reporting a Solicited Injection Site or Systemic Adverse Event After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 through Day 7 post-vaccination ]

3.  Primary:   Number of Participants With Evaluated Laboratory Abnormalities After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 through Day 60 post-vaccination 1 ]

4.  Primary:   Number of Participants With Seroconversion to M2e Antigen During Initial Treatment and Follow Up Period After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine   [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ]

5.  Primary:   Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or a Placebo Vaccine.   [ Time Frame: Day 15 through Month 10 Post-vaccination 1 ]

6.  Secondary:   Number of Participants With Signs and Symptoms of Influenza After Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Month 4 through Month 10 post-vaccination 1 ]

7.  Secondary:   Number of Participants With Seroconversion to M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]

8.  Secondary:   Geometric Mean Titers of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]

9.  Secondary:   Geometric Mean Titer Ratios of Anti-M2e Antigen by Immunoglobulin G (IgG) Subclasses Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 and Day 60 Post-vaccination 1 ]

10.  Secondary:   Geometric Mean Titers (GMTs) of Anti-Hepatitis B Core Antibodies Using Immunoglobulin G (IgG) ELISA Before and Post-Vaccination With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 and Day 15 through Month 10 post-vaccination 1 ]

11.  Secondary:   Number of Participants With Seropositivity to Hepatitis B Core Antigen Pre- and Post-Vaccination 1 With ACAM FLU A, or ACAM FLU A With Adjuvant, or Placebo Vaccine.   [ Time Frame: Day 0 and Day 15 through Month 10 Post-vaccination 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


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


No publications provided by Sanofi

Publications automatically indexed to this study:

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00819013     History of Changes
Other Study ID Numbers: H-261-001
Study First Received: October 10, 2008
Results First Received: November 1, 2011
Last Updated: January 16, 2012
Health Authority: United States: Food and Drug Administration