Sanofi H1N1 + TIV - Adults and Elderly

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943878
First received: July 21, 2009
Last updated: July 26, 2012
Last verified: April 2010
Results First Received: April 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Trivalent inactivated influenza vaccine
Biological: Inactivated H1N1 Vaccine
Drug: 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 healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 7AUG2009 and 28AUG2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Participant Flow:   Overall Study
    Group 1: H1N1+Placebo; H1N1+Placebo; TIV     Group 2: H1N1+TIV; H1N1+Placebo; Placebo     Group 3: H1N1+Placebo; H1N1+TIV; Placebo     Group 4: TIV+Placebo; H1N1+Placebo; H1N1  
STARTED     202     200     203     200  
COMPLETED     200     198     197     198  
NOT COMPLETED     2     2     6     2  



  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
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Total Total of all reporting groups

Baseline Measures
    Group 1: H1N1+Placebo; H1N1+Placebo; TIV     Group 2: H1N1+TIV; H1N1+Placebo; Placebo     Group 3: H1N1+Placebo; H1N1+TIV; Placebo     Group 4: TIV+Placebo; H1N1+Placebo; H1N1     Total  
Number of Participants  
[units: participants]
  202     200     203     200     805  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     101     103     102     102     408  
>=65 years     101     97     101     98     397  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 16.2     58.4  ± 16.7     58.5  ± 16.6     59.1  ± 15.3     58.8  ± 16.2  
Gender  
[units: participants]
         
Female     99     118     104     123     444  
Male     103     82     99     77     361  
Region of Enrollment  
[units: participants]
         
United States     202     200     203     200     805  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]

2.  Primary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]

3.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 180 after the last vaccination ]

4.  Primary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

5.  Primary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination ]

6.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

7.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

8.  Primary:   Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

9.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

10.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

11.  Primary:   Number of Participants Reporting Fever After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

12.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

13.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

14.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

15.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first placebo vaccination ]

16.  Primary:   Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second placebo vaccination ]

17.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

18.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

19.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

20.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first placebo vaccination ]

21.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second placebo vaccination ]

22.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

23.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

24.  Secondary:   Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

25.  Secondary:   Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination ]

26.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

27.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 63 ]

28.  Secondary:   Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after second H1N1 vaccination ]
  Hide Outcome Measure 28

Measure Type Secondary
Measure Title Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine
Measure Description Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Time Frame Day 21 after second H1N1 vaccination  
Safety Issue No  

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.
Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Reporting Groups
  Description
Group 1: H1N1+Placebo; H1N1+Placebo; TIV Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: H1N1+TIV; H1N1+Placebo; Placebo Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
Group 3: H1N1+Placebo; H1N1+TIV; Placebo Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42

Measured Values
    Group 1: H1N1+Placebo; H1N1+Placebo; TIV     Group 2: H1N1+TIV; H1N1+Placebo; Placebo     Group 3: H1N1+Placebo; H1N1+TIV; Placebo     Group 4: TIV+Placebo; H1N1+Placebo; H1N1  
Number of Participants Analyzed  
[units: participants]
  94     92     90     90  
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine  
[units: Participants]
  89     82     87     80  

No statistical analysis provided for Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine



29.  Secondary:   Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after second H1N1 vaccination ]


  Serious Adverse Events


  Other Adverse Events


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: Sharon E. Frey, M.D.
Organization: Division of Infectious Diseases and Immunology, Saint Louis University Medical School
phone: 314-977-5500
e-mail: freyse@slu.edu


No publications provided


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943878     History of Changes
Other Study ID Numbers: 09-0039, N01AI80003C
Study First Received: July 21, 2009
Results First Received: April 14, 2011
Last Updated: July 26, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board