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Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00963157
First received: August 20, 2009
Last updated: November 13, 2014
Last verified: January 2011
Results First Received: November 10, 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: Drug: AS03
Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A

  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 adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

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
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Participant Flow:   Overall Study
    3.75 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine Unadjuvanted     15 mcg H1N1 Vaccine + AS03 Adjuvant     15 mcg H1N1 Vaccine Unadjuvanted  
STARTED     156     163     160     157     153  
COMPLETED     151     159     155     150     151  
NOT COMPLETED     5     4     5     7     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
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
    3.75 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine Unadjuvanted     15 mcg H1N1 Vaccine + AS03 Adjuvant     15 mcg H1N1 Vaccine Unadjuvanted     Total  
Number of Participants  
[units: participants]
  156     163     160     157     153     789  
Age  
[units: participants]
           
<=18 years     0     0     0     0     0     0  
Between 18 and 65 years     107     111     110     109     107     544  
>=65 years     49     52     50     48     46     245  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 17.6     51.7  ± 18.0     51.6  ± 17.8     50.1  ± 18.3     52.1  ± 18.6     51.4  ± 18.0  
Gender  
[units: participants]
           
Female     89     84     93     85     72     423  
Male     67     79     67     72     81     366  
Region of Enrollment  
[units: participants]
           
United States     156     163     160     157     153     789  



  Outcome Measures
  Show All Outcome Measures

1.  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 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

2.  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 ]

3.  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 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination ]

4.  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 ]

5.  Primary:   Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)   [ Time Frame: Day 0 through Day 365 after the last vaccination ]

6.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

7.  Primary:   Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

8.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination   [ Time Frame: 8-10 days after first vaccination ]

9.  Primary:   Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination   [ Time Frame: 8-10 days after second vaccination ]

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

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

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

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

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

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

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

17.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]
  Hide Outcome Measure 17

Measure Type Primary
Measure Title Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Measure Description Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.
Time Frame Within 8 days (Day 0-7) post second vaccination  
Safety Issue Yes  

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 the second vaccination are included. Analyses are as treated.

Reporting Groups
  Description
3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.

Measured Values
    3.75 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine + AS03 Adjuvant     7.5 mcg H1N1 Vaccine Unadjuvanted     15 mcg H1N1 Vaccine + AS03 Adjuvant     15 mcg H1N1 Vaccine Unadjuvanted  
Number of Participants Analyzed  
[units: participants]
  147     151     151     147     140  
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination  
[units: Participants]
         
Redness     28     29     30     40     30  
Swelling     27     17     25     30     23  

No statistical analysis provided for Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination



18.  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 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

19.  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 the first vaccination ]

20.  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 8 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the first vaccination ]

21.  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 the first vaccination ]

22.  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 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

23.  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 the second vaccination ]

24.  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 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second vaccination ]

25.  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 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

26.  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 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8 after the second vaccination ]

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 H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

28.  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 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 180 after the second 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 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 270 after the second vaccination ]

30.  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 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

31.  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 ]

32.  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 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

33.  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 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]

34.  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 8 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination ]

35.  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 ]

36.  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 180 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination ]

37.  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 270 Days Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination ]


  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
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