CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943488
First received: July 21, 2009
Last updated: October 25, 2012
Last verified: March 2010
Results First Received: March 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
Intervention: Biological: Inactivated H1N1 Vaccine

  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 07AUG2009 and 21AUG2009

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
H1N1 Vaccine 15 Mcg Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Participant Flow:   Overall Study
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg  
STARTED     204     204  
COMPLETED     203     202  
NOT COMPLETED     1     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
H1N1 Vaccine 15 Mcg Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
Total Total of all reporting groups

Baseline Measures
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg     Total  
Number of Participants  
[units: participants]
  204     204     408  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     102     98     200  
>=65 years     102     106     208  
Age  
[units: years]
Mean ± Standard Deviation
  57.9  ± 17.1     59.5  ± 15.9     58.7  ± 16.5  
Gender  
[units: participants]
     
Female     105     114     219  
Male     99     90     189  
Region of Enrollment  
[units: participants]
     
United States     204     204     408  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

2.  Primary:   Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

3.  Primary:   Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

4.  Primary:   Number of Participants Reporting Measured Injection Site Reactions of Swelling and Redness After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

5.  Primary:   Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

6.  Primary:   Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

7.  Primary:   Number of Participants Reporting Fever After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

8.  Primary:   Number of Participants Reporting Fever After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

9.  Primary:   Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

10.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

11.  Primary:   Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first vaccination ]

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

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

14.  Primary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

15.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

16.  Primary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

17.  Primary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

18.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

19.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

20.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

21.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

22.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 8-10 after the second vaccination ]

23.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 8-10 after the second vaccination ]

24.  Secondary:   Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 21 after the second vaccination ]

25.  Secondary:   Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.   [ Time Frame: Day 21 after the second vaccination ]


  Serious Adverse Events


  Other Adverse Events
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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
H1N1 Vaccine 15 Mcg Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
H1N1 Vaccine 30 Mcg Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.

Other Adverse Events
    H1N1 Vaccine 15 Mcg     H1N1 Vaccine 30 Mcg  
Total, other (not including serious) adverse events      
# participants affected / at risk     158/204     168/204  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     11/204 (5.39%)     22/204 (10.78%)  
# events     12     25  
General disorders      
Injection site haematoma * 1    
# participants affected / at risk     9/204 (4.41%)     17/204 (8.33%)  
# events     9     17  
Feeling hot † 1    
# participants affected / at risk     27/204 (13.24%)     39/204 (19.12%)  
# events     28     43  
Malaise † 1    
# participants affected / at risk     53/204 (25.98%)     69/204 (33.82%)  
# events     67     87  
Injection site pain † 1    
# participants affected / at risk     49/204 (24.02%)     73/204 (35.78%)  
# events     62     98  
Tenderness † 1 [4]    
# participants affected / at risk     89/204 (43.63%)     119/204 (58.33%)  
# events     122     186  
Injection site erythema † 1    
# participants affected / at risk     40/204 (19.61%)     41/204 (20.10%)  
# events     48     51  
Injection site swelling (functional grading) † 1 [5]    
# participants affected / at risk     30/204 (14.71%)     34/204 (16.67%)  
# events     34     40  
Injection site swelling (measured) † 1 [5]    
# participants affected / at risk     35/204 (17.16%)     41/204 (20.10%)  
# events     39     47  
Infections and infestations      
Upper respiratory tract infection * 1    
# participants affected / at risk     15/204 (7.35%)     17/204 (8.33%)  
# events     15     17  
Musculoskeletal and connective tissue disorders      
Myalgia † 1    
# participants affected / at risk     41/204 (20.10%)     42/204 (20.59%)  
# events     49     51  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     58/204 (28.43%)     52/204 (25.49%)  
# events     72     67  
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
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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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