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

Sanofi Pasteur, TIV + H1N1, Pediatric Population

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00943202
First received: July 21, 2009
Last updated: April 11, 2013
Last verified: December 2010
Results First Received: April 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Inactivated H1N1 Vaccine
Biological: Trivalent Inactivated Influenza 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 males and females, age 6 months to 17 years, recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 20AUG2009 and 21SEP2009.

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: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.

Participant Flow:   Overall Study
    Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
STARTED   133   133   133   132 
COMPLETED   132   131   133   131 
NOT COMPLETED   1   2   0   1 



  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
Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
Total Total of all reporting groups

Baseline Measures
   Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   133   133   132   531 
Age 
[Units: Participants]
         
<=18 years   133   133   133   132   531 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.0  (5.0)   8.2  (5.3)   7.9  (5.3)   8.5  (5.0)   8.1  (5.1) 
Gender 
[Units: Participants]
         
Female   68   71   57   57   253 
Male   65   62   76   75   278 
Region of Enrollment 
[Units: Participants]
         
United States   133   133   133   132   531 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Age 6 Months to Less Than 36 Months 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 ]

2.  Primary:   Number of Participants Age 36 Months to 9 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 10 to 17 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 ]

4.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

5.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

6.  Primary:   Number of Participants Age 10 to 17 Years 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 Age 6 to Less Than 36 Months 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 Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

9.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

10.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

11.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

12.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

13.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

14.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

15.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the First Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first vaccination ]

16.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

17.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

18.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second vaccination ]

19.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

20.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

21.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Systemic Reactions After the Third Vaccination   [ Time Frame: Within 8 days (Day 0-7) post third vaccination ]

22.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

23.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

24.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

25.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

26.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

27.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

28.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

29.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

30.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

31.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

32.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

33.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post first H1N1 vaccination ]

34.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

35.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

36.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination   [ Time Frame: Within 8 days (Day 0-7) post second H1N1 vaccination ]

37.  Primary:   Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

38.  Primary:   Number of Participants Age 36 Months to 9 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

39.  Primary:   Number of Participants Age 10 to 17 Years Reporting Solicited Quantitative Local Reactions After the TIV Vaccination   [ Time Frame: Within 8 days (Day 0-7) post TIV vaccination ]

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

41.  Primary:   Number of Participants Age 6 Months to Less Than 36 Months 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 ]

42.  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 H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]

43.  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 H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine   [ Time Frame: Day 21 after first H1N1 vaccination ]

44.  Secondary:   Number of Participants Age 6 to Less Than 36 Months 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 0 prior to first vaccination and 21 days after last vaccination ]

45.  Secondary:   Number of Participants Age 36 Months to 9 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 0 prior to first vaccination and Day 21 after last vaccination ]

46.  Secondary:   Number of Participants Age 10 to 17 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 0 prior to first vaccination and Day 21 after last vaccination ]

47.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]

48.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]

49.  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 Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination   [ Time Frame: Day 21 after last vaccination ]

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

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

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

53.  Secondary:   Number of Participants Age 6 to Less Than 36 Months 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 first vaccination and 21 days after the second H1N1 vaccination ]

54.  Secondary:   Number of Participants Age 36 Months to 9 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 first vaccination and 21 days after the second H1N1 vaccination ]

55.  Secondary:   Number of Participants Age 10 to 17 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 first vaccination and 21 days after the 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: Day 0-H1N1; Day 21-H1N1; Day 42-TIV Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Group 2: Day 0-H1N1+TIV; Day 21-H1N1 Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
Group 3: Day 0-H1N1; Day 21-H1N1+TIV Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1 Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.

Other Adverse Events
    Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV   Group 2: Day 0-H1N1+TIV; Day 21-H1N1   Group 3: Day 0-H1N1; Day 21-H1N1+TIV   Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1
Total, other (not including serious) adverse events         
# participants affected / at risk   124/133 (93.23%)   125/133 (93.98%)   124/133 (93.23%)   125/132 (94.70%) 
Gastrointestinal disorders         
Diarrhoea * 1         
# participants affected / at risk   18/133 (13.53%)   6/133 (4.51%)   9/133 (6.77%)   10/132 (7.58%) 
# events   22   7   13   13 
Nausea † 1 [4]         
# participants affected / at risk   25/98 (25.51%)   18/100 (18.00%)   19/98 (19.39%)   13/104 (12.50%) 
# events   31   34   29   16 
Vomiting † 1         
# participants affected / at risk   16/133 (12.03%)   8/133 (6.02%)   14/133 (10.53%)   11/132 (8.33%) 
# events   20   12   25   11 
General disorders         
Injection site haematoma * 1         
# participants affected / at risk   3/133 (2.26%)   8/133 (6.02%)   6/133 (4.51%)   4/132 (3.03%) 
# events   3   9   6   4 
Pyrexia * 1         
# participants affected / at risk   5/133 (3.76%)   4/133 (3.01%)   3/133 (2.26%)   8/132 (6.06%) 
# events   5   4   3   8 
Pyrexia † 1         
# participants affected / at risk   14/133 (10.53%)   5/133 (3.76%)   15/133 (11.28%)   13/132 (9.85%) 
# events   15   8   23   13 
Irritability † 1 [5]         
# participants affected / at risk   22/35 (62.86%)   20/33 (60.61%)   23/35 (65.71%)   17/28 (60.71%) 
# events   38   45   42   28 
Feeling hot † 1 [4]         
# participants affected / at risk   25/98 (25.51%)   21/100 (21.00%)   20/98 (20.41%)   15/104 (14.42%) 
# events   26   38   31   15 
Malaise † 1 [6]         
# participants affected / at risk   24/49 (48.98%)   15/49 (30.61%)   13/49 (26.53%)   14/53 (26.42%) 
# events   31   35   18   17 
Decreased activity † 1 [4]         
# participants affected / at risk   27/98 (27.55%)   21/100 (21.00%)   26/98 (26.53%)   21/104 (20.19%) 
# events   35   44   40   26 
Injection site pain † 1         
# participants affected / at risk   70/133 (52.63%)   67/133 (50.38%)   75/133 (56.39%)   65/132 (49.24%) 
# events   117   112   133   98 
Tenderness † 1 [7]         
# participants affected / at risk   83/133 (62.41%)   82/133 (61.65%)   91/133 (68.42%)   90/132 (68.18%) 
# events   155   158   185   159 
Injection site erythema † 1         
# participants affected / at risk   75/133 (56.39%)   68/133 (51.13%)   76/133 (57.14%)   72/132 (54.55%) 
# events   130   131   154   141 
Injection site swelling (functional grading) † 1 [8]         
# participants affected / at risk   35/133 (26.32%)   39/133 (29.32%)   39/133 (29.32%)   51/132 (38.64%) 
# events   55   70   68   72 
Injection site swelling (measured) † 1 [8]         
# participants affected / at risk   37/133 (27.82%)   45/133 (33.83%)   43/133 (32.33%)   53/132 (40.15%) 
# events   60   79   77   77 
Infections and infestations         
Nasopharyngitis * 1         
# participants affected / at risk   13/133 (9.77%)   13/133 (9.77%)   10/133 (7.52%)   11/132 (8.33%) 
# events   14   14   11   12 
Upper respiratory tract infection * 1         
# participants affected / at risk   16/133 (12.03%)   11/133 (8.27%)   15/133 (11.28%)   14/132 (10.61%) 
# events   16   11   18   20 
Metabolism and nutrition disorders         
Decreased Appetite † 1 [5]         
# participants affected / at risk   9/35 (25.71%)   8/33 (24.24%)   11/35 (31.43%)   13/28 (46.43%) 
# events   16   15   15   14 
Musculoskeletal and connective tissue disorders         
Myalgia † 1 [4]         
# participants affected / at risk   21/98 (21.43%)   15/100 (15.00%)   23/98 (23.47%)   19/104 (18.27%) 
# events   30   29   32   23 
Nervous system disorders         
Lethargy † 1 [5]         
# participants affected / at risk   14/35 (40.00%)   7/33 (21.21%)   10/35 (28.57%)   9/28 (32.14%) 
# events   20   14   16   10 
Headache † 1 [4]         
# participants affected / at risk   40/98 (40.82%)   27/100 (27.00%)   33/98 (33.67%)   27/104 (25.96%) 
# events   55   60   53   37 
Respiratory, thoracic and mediastinal disorders         
Cough * 1         
# participants affected / at risk   16/133 (12.03%)   9/133 (6.77%)   9/133 (6.77%)   21/132 (15.91%) 
# events   16   10   10   23 
Nasal congestion * 1         
# participants affected / at risk   7/133 (5.26%)   11/133 (8.27%)   8/133 (6.02%)   11/132 (8.33%) 
# events   8   11   8   11 
Oropharyngeal pain * 1         
# participants affected / at risk   12/133 (9.02%)   5/133 (3.76%)   4/133 (3.01%)   9/132 (6.82%) 
# events   13   5   4   10 
Rhinorrhoea * 1         
# participants affected / at risk   23/133 (17.29%)   11/133 (8.27%)   7/133 (5.26%)   12/132 (9.09%) 
# events   25   12   7   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
Due to difficulties identifying children in the youngest age stratum who were previously primed, enrollment in this stratum was closed prior to meeting the planned number of participants.


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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: Sharon E. Frey, M.D.
Organization: Division of Infectious Diseases and Immunology, Saint Louis University Medical School
phone: 314-977-5500
e-mail: freyse@slu.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00943202     History of Changes
Other Study ID Numbers: 09-0047
N01AI80003C
Study First Received: July 21, 2009
Results First Received: April 28, 2011
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration
United States: Federal Government