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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
History of Changes
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
  Hide Participant Flow

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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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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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

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 ]
  Show Outcome Measure 4

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 ]
  Show Outcome Measure 5

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 ]
  Show Outcome Measure 6

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 ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 8

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

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

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

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 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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 ]
  Show Outcome Measure 14

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 ]
  Show Outcome Measure 15

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 ]
  Show Outcome Measure 16

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 ]
  Show Outcome Measure 17

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 ]
  Show Outcome Measure 18

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 ]
  Show Outcome Measure 19

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 ]
  Show Outcome Measure 20

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 ]
  Show Outcome Measure 21

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 ]
  Show Outcome Measure 22

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 ]
  Show Outcome Measure 23

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 ]
  Show Outcome Measure 24

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 ]
  Show Outcome Measure 25

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 ]
  Show Outcome Measure 26

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 ]
  Show Outcome Measure 27

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 ]
  Show Outcome Measure 28

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 ]
  Show Outcome Measure 29


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Additional Description For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    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, other (not including serious) adverse events          
# participants affected / at risk     167/202     170/200     169/203     175/200  
Gastrointestinal disorders          
Nausea † 1        
# participants affected / at risk     18/202 (8.91%)     21/200 (10.50%)     16/203 (7.88%)     22/200 (11.00%)  
# events     22     22     20     27  
General disorders          
Injection site haematoma * 1        
# participants affected / at risk     18/202 (8.91%)     30/200 (15.00%)     20/203 (9.85%)     18/200 (9.00%)  
# events     18     35     26     20  
Feeling hot † 1        
# participants affected / at risk     26/202 (12.87%)     24/200 (12.00%)     20/203 (9.85%)     24/200 (12.00%)  
# events     32     28     24     28  
Malaise † 1        
# participants affected / at risk     59/202 (29.21%)     61/200 (30.50%)     57/203 (28.08%)     55/200 (27.50%)  
# events     76     85     80     70  
Injection site pain † 1        
# participants affected / at risk     66/202 (32.67%)     87/200 (43.50%)     72/203 (35.47%)     67/200 (33.50%)  
# events     97     109     91     89  
Tenderness † 1 [4]        
# participants affected / at risk     98/202 (48.51%)     115/200 (57.50%)     111/203 (54.68%)     109/200 (54.50%)  
# events     184     159     162     166  
Injection site erythema † 1        
# participants affected / at risk     73/202 (36.14%)     67/200 (33.50%)     71/203 (34.98%)     75/200 (37.50%)  
# events     115     107     97     118  
Injection site swelling (functional grading) † 1 [5]        
# participants affected / at risk     57/202 (28.22%)     56/200 (28.00%)     50/203 (24.63%)     59/200 (29.50%)  
# events     88     73     67     84  
Injection site swelling (measured) † 1 [5]        
# participants affected / at risk     61/202 (30.20%)     59/200 (29.50%)     52/203 (25.62%)     61/200 (30.50%)  
# events     93     81     69     89  
Infections and infestations          
Upper respiratory tract infection * 1        
# participants affected / at risk     16/202 (7.92%)     18/200 (9.00%)     23/203 (11.33%)     18/200 (9.00%)  
# events     16     18     23     19  
Musculoskeletal and connective tissue disorders          
Myalgia † 1        
# participants affected / at risk     42/202 (20.79%)     40/200 (20.00%)     39/203 (19.21%)     37/200 (18.50%)  
# events     51     50     46     43  
Nervous system disorders          
Headache † 1        
# participants affected / at risk     64/202 (31.68%)     62/200 (31.00%)     60/203 (29.56%)     60/200 (30.00%)  
# events     87     89     81     80  
Respiratory, thoracic and mediastinal disorders          
Nasal congestion * 1        
# participants affected / at risk     3/202 (1.49%)     4/200 (2.00%)     12/203 (5.91%)     6/200 (3.00%)  
# events     3     4     12     6  
Rhinorrhoea * 1        
# participants affected / at risk     6/202 (2.97%)     6/200 (3.00%)     4/203 (1.97%)     10/200 (5.00%)  
# events     7     6     4     10  
† Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.0)
[4] Tenderness was solicited as a reaction at the vaccination site.
[5] Injection site swelling was solicited separately for functional grading of impact on daily activities and as a measured reaction.



  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