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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: January 29, 2015
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: 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 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 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 (86.64%)   255/291 (87.63%) 
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.


  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.


Results Point of Contact:  
Name/Title: Karen Kotloff, MD
Organization: Center for Vaccine Development, University of Maryland
phone: 401-706-5328
e-mail: kkotloff@medicine.umaryland.edu


Publications of Results:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00944073     History of Changes
Other Study ID Numbers: 09-0054
Study First Received: July 21, 2009
Results First Received: March 17, 2011
Last Updated: January 29, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration