Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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 ]

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
  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 (82.67%)   170/200 (85.00%)   169/203 (83.25%)   175/200 (87.50%) 
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.



  Limitations and Caveats
  Hide 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.


  More Information