Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00944073
First received: July 21, 2009
Last updated: May 10, 2012
Last verified: March 2010
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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 pediatric males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 19AUG2009 and 9SEP2009.

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

Participant Flow:   Overall Study
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
STARTED     292     291  
COMPLETED     287     287  
NOT COMPLETED     5     4  



  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
15 Mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 Mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine     Total  
Number of Participants  
[units: participants]
  292     291     583  
Age  
[units: participants]
     
<=18 years     292     291     583  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.6  ± 5.5     7.3  ± 5.2     7.5  ± 5.3  
Gender  
[units: participants]
     
Female     129     137     266  
Male     163     154     317  
Region of Enrollment  
[units: participants]
     
United States     292     291     583  



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

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

3.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

4.  Primary:   Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

5.  Primary:   Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

6.  Primary:   Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

7.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

8.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

9.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

10.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second vaccination ]

11.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Day 0-7 after first vaccination ]

12.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Day 0-7 after second 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 Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0   [ Time Frame: Day 0 ]

15.  Primary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 ]

16.  Primary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 21 ]

17.  Primary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0   [ Time Frame: Day 0 ]

18.  Primary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 ]

19.  Primary:   Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 21 ]

20.  Primary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination ]

21.  Primary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

22.  Primary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

23.  Primary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ]

24.  Primary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Day 21 after first vaccination ]

25.  Primary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to and Days 8-10 and 21 after first vaccination ]

26.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

27.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

28.  Secondary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

29.  Secondary:   Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

30.  Secondary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 8-10 after the second vaccination ]

31.  Secondary:   Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 21 after the second vaccination ]

32.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

33.  Secondary:   Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

34.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

35.  Secondary:   Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ]

36.  Secondary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ]

37.  Secondary:   Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine   [ Time Frame: Day 0 prior to first vaccination and 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
15 Mcg H1N1 Vaccine Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
30 Mcg H1N1 Vaccine Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.

Other Adverse Events
    15 Mcg H1N1 Vaccine     30 Mcg H1N1 Vaccine  
Total, other (not including serious) adverse events      
# participants affected / at risk     253/292     255/291  
Gastrointestinal disorders      
Diarrhoea * 1    
# participants affected / at risk     15/292 (5.14%)     22/291 (7.56%)  
# events     17     23  
Nausea † 1 [4]    
# participants affected / at risk     25/198 (12.63%)     33/198 (16.67%)  
# events     28     36  
Vomiting † 1    
# participants affected / at risk     20/292 (6.85%)     18/291 (6.19%)  
# events     23     20  
General disorders      
Pyrexia † 1    
# participants affected / at risk     16/292 (5.48%)     14/291 (4.81%)  
# events     17     15  
Irritability † 1 [5]    
# participants affected / at risk     48/94 (51.06%)     55/98 (56.12%)  
# events     69     80  
Feeling hot † 1 [4]    
# participants affected / at risk     22/198 (11.11%)     21/193 (10.88%)  
# events     25     25  
Malaise † 1 [6]    
# participants affected / at risk     18/98 (18.37%)     30/96 (31.25%)  
# events     22     36  
Decreased activity † 1 [4]    
# participants affected / at risk     32/198 (16.16%)     39/193 (20.21%)  
# events     38     44  
Injection site pain † 1    
# participants affected / at risk     101/292 (34.59%)     108/291 (37.11%)  
# events     125     144  
Tenderness † 1 [7]    
# participants affected / at risk     135/292 (46.23%)     141/291 (48.45%)  
# events     192     196  
Injection site erythema † 1    
# participants affected / at risk     89/292 (30.48%)     91/291 (31.27%)  
# events     114     122  
Injection site swelling (functional grading) † 1 [8]    
# participants affected / at risk     54/292 (18.49%)     48/291 (16.49%)  
# events     66     61  
Injection site swelling (measured) † 1 [8]    
# participants affected / at risk     50/292 (17.12%)     46/291 (15.81%)  
# events     61     60  
Infections and infestations      
Nasopharyngitis * 1    
# participants affected / at risk     24/292 (8.22%)     12/291 (4.12%)  
# events     26     13  
Upper respiratory tract infection * 1    
# participants affected / at risk     27/292 (9.25%)     34/291 (11.68%)  
# events     29     36  
Metabolism and nutrition disorders      
Decreased Appetite † 1 [5]    
# participants affected / at risk     33/94 (35.11%)     22/98 (22.45%)  
# events     35     26  
Musculoskeletal and connective tissue disorders      
Myalgia † 1 [4]    
# participants affected / at risk     24/198 (12.12%)     32/193 (16.58%)  
# events     30     35  
Nervous system disorders      
Lethargy † 1 [5]    
# participants affected / at risk     21/94 (22.34%)     25/98 (25.51%)  
# events     24     31  
Headache † 1 [4]    
# participants affected / at risk     52/198 (26.26%)     53/193 (27.46%)  
# events     70     68  
Respiratory, thoracic and mediastinal disorders      
Cough * 1    
# participants affected / at risk     14/292 (4.79%)     17/291 (5.84%)  
# events     14     17  
Nasal congestion * 1    
# participants affected / at risk     7/292 (2.40%)     16/291 (5.50%)  
# events     7     16  
Rhinorrhoea * 1    
# participants affected / at risk     18/292 (6.16%)     17/291 (5.84%)  
# events     20     18  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (13.0)
[4] Solicited from participants aged 36 months to 17 years only.
[5] Solicited from participants aged 6 to less than 36 months only.
[6] Solicited from participants aged 10 to 17 years only.
[7] Tenderness was solicited as a reaction at the vaccination site.
[8] 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
To limit blood draws, the younger 2 age strata were assigned varying blood draw schedules and there were deviations from the schedules, reducing the size of subsets on the same schedule, such uniformity being optimal for longitudinal comparisons.


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