Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    FID07
Previous Study | Return to List | Next Study

Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00391391
Recruitment Status : Completed
First Posted : October 24, 2006
Results First Posted : November 22, 2011
Last Update Posted : December 1, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Orthomyxoviridae Infection
Influenza
Myxovirus Infection
Interventions Biological: Split, Inactivated, Trivalent Influenza Vaccine
Biological: Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Enrollment 520
Recruitment Details Study participants ere enrolled from 19 October to 12 December 2006 in 20 clinical centers in the US.
Pre-assignment Details A total of 517 of the 520 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Period Title: Overall Study
Started 98 [1] 97 161 [1] 164 [1]
Completed 89 87 138 145
Not Completed 9 10 23 19
Reason Not Completed
Adverse Event             0             0             0             1
Lost to Follow-up             1             3             7             4
Protocol Violation             2             3             6             7
Withdrawal by Subject             6             4             10             7
[1]
1 participant was not vaccinated.
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age Total
Hide Arm/Group Description Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine Total of all reporting groups
Overall Number of Baseline Participants 97 97 160 163 517
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 97 participants 160 participants 163 participants 517 participants
<=18 years
97
 100.0%
97
 100.0%
160
 100.0%
163
 100.0%
517
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 97 participants 97 participants 160 participants 163 participants 517 participants
22.6  (7.51) 21.8  (8.03) 69.6  (22.2) 70.8  (21.6) 46.5  (14.835)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 97 participants 160 participants 163 participants 517 participants
Female
45
  46.4%
43
  44.3%
70
  43.8%
84
  51.5%
242
  46.8%
Male
52
  53.6%
54
  55.7%
90
  56.3%
79
  48.5%
275
  53.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants 97 participants 160 participants 163 participants 517 participants
97 97 160 163 517
1.Primary Outcome
Title Geometric Mean Titers (GMTs) Before and Post Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Hide Description Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Time Frame Day 0 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were determined in the per-protocol population.
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 69 68 115 120
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A/H1N1 Pre-vaccination
8.9
(7.1 to 11.2)
9.6
(7.5 to 12.3)
20.5
(15.6 to 26.9)
26.9
(19.6 to 37.1)
Serogroup A/H1N1 Post-vaccination 1
58.5
(28.6 to 119.4)
113.1
(59.9 to 213.7)
100.1
(55.0 to 182.1)
264.2
(162.8 to 428.9)
Serogroup A/H1N1 Post-vaccination 2
138.3
(105.2 to 181.8)
160.0
(123.7 to 206.9)
162.9
(128.7 to 206.3)
390.6
(308.2 to 495.0)
Serogroup A/H3N2 Pre-vaccination
22.4
(14.0 to 35.9)
20.9
(13.7 to 31.9)
222.2
(165.4 to 298.5)
171.0
(121.5 to 240.7)
Serogroup A/H3N2 Post-vaccination 1
341.8
(142.9 to 817.7)
566.9
(304.6 to 1054.9)
1012.5
(666.9 to 1537.2)
1256.9
(898.2 to 1758.8)
Serogroup A/H3N2 Post-vaccination 2
614.8
(471.3 to 802.0)
471.4
(368.0 to 603.7)
1111.0
(944.0 to 1307.5)
1344.4
(1146.1 to 1577.1)
Serogroup B Pre-vaccination
5.3
(4.9 to 5.8)
5.4
(5.0 to 5.9)
8.3
(7.1 to 9.7)
6.8
(6.0 to 7.7)
Serogroup B Post-vaccination 1
7.4
(4.4 to 12.5)
9.7
(4.2 to 22.1)
46.6
(23.3 to 93.3)
28.8
(16.0 to 52.0)
Serogroup B Post-vaccination 2
31.1
(23.7 to 40.8)
18.2
(13.9 to 24.0)
56.4
(43.8 to 72.7)
51.6
(40.8 to 65.2)
2.Secondary Outcome
Title Percentage of Participants That Achieved A 4-Fold Rise in Serum HAI Antibody Titer Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Hide Description Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
4-Fold Rise in Serum HAI Antibody Titers were determined in the per-protocol population
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 69 68 115 120
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A/H1N1 Post-vaccination 1 52 75 65 74
Serogroup A/H1N1 Post-vaccination 2 91 88 70 78
Serogroup A/H3N2 Post-vaccination 1 81 80 44 63
Serogroup A/H3N2 Post-vaccination 2 88 91 50 62
Serogroup B Post-vaccination 1 5 10 44 40
Serogroup B Post-vaccination 2 44 21 55 53
3.Secondary Outcome
Title Percentage of Participants That Achieved Seroprotection Before and Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Hide Description

Seroprotection was defined as participants achieving a post-dose antibody titers ≥40.

Antibody titers against each strain of influenza hemagglutinin were measured in the sera using the hemagglutination inhibition (HI) technique.

Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to vaccine antigens were determined in the per-protocol population
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 69 68 115 120
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A/H1N1 Pre-vaccination 9 12 33 40
Serogroup A/H1N1 Post-vaccination 1 52 75 79 95
Serogroup A/H1N1 Post-vaccination 2 91 93 92 99
Serogroup A/H3N2 Pre-vaccination 32 29 86 80
Serogroup A/H3N2 Post-vaccination 1 85 95 97 100
Serogroup A/H3N2 Post-vaccination 2 100 100 99 100
Serogroup B Pre-vaccination 2 2 9 3
Serogroup B Post-vaccination 1 5 10 47 42
Serogroup B Post-vaccination 2 44 21 63 58
4.Secondary Outcome
Title Percentage of Participants That Achieved Seroconversion Post-vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine
Hide Description Seroconversion was defined as the conversion to a post-vaccination titer of ≥ 40 for subjects with pre-vaccination titer < 10, or at least a 4-fold increase in post vaccination titer for subjects with pre vaccination titer ≥ 10.
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion to vaccine antigens were determined in the per-protocol population
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 69 97 160 120
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A/H1N1 Post-vaccination 1 52 75 65 74
Serogroup A/H1N1 Post-vaccination 2 91 88 70 78
Serogroup A/H3N2 Post-vaccination 1 81 80 44 63
Serogroup A/H3N2 Post-vaccination 2 88 91 50 62
Serogroup B Post-vaccination 1 5 10 44 40
Serogroup B Post-vaccination 2 44 21 55 53
5.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 6 to 35 Months.
Hide Description Solicited injection site reactions: Tenderness, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability.
Time Frame Day 0 to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety parameters were determined post-vaccination in the safety, intend-to-treat population.
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 97 97 0 0
Measure Type: Number
Unit of Measure: Participants
Any injection site tenderness Injection 1 51 43
Grade 3 Tenderness (Reduced movement) 0 0
Any Injection site redness Injection 1 48 27
Grade 3 redness ( ≥ 5 cm) 0 0
Any Injection site swelling Injection 1 23 15
Grade 3 swelling ( ≥ 5 cm) 0 0
Any Injection site induration Injection 1 24 13
Grade 3 induration ( ≥ 5 cm) 0 0
Any Injection site ecchymosis Injection 1 12 13
Grade 3 ecchymosis ( ≥ 5 cm) 1 0
Any injection site tenderness Injection 2 48 49
Grade 3 Tenderness (Reduced movement) 1 1
Any Injection site redness Injection 2 48 28
Grade 3 redness ( ≥ 5 cm) 1 0
Any Injection site swelling Injection 2 18 13
Grade 3 swelling ( ≥ 5 cm) 1 0
Any Injection site induration Injection 2 18 14
Grade 3 induration ( ≥ 5 cm) 0 0
Any Injection site ecchymosis Injection 2 23 13
Grade 3 ecchymosis ( ≥ 5 cm) 1 0
Any Solicited Fever Injection 1 10 10
Grade 3 Fever > 103.1°F 1 0
Any Solicited Vomiting Injection 1 5 6
Grade 3 Vomiting ≥ 6 episodes per 24 hours 0 0
Any Solicited Crying Abnormal Injection 1 17 29
Grade 3 Crying Abnormal >3 hours 3 0
Any Solicited Drowsiness Injection 1 21 24
Grade 3 Drowsiness Sleeping most of the time 3 0
Any Solicited Appetite Lost Injection 1 20 21
Grade 3 Appetite Lost refuses most feeds 3 0
Any Solicited Irritability Injection 1 37 39
Grade 3 Irritability inconsolable 2 1
Any Solicited Fever Injection 2 6 9
Grade 3 Fever > 103.1°F 0 1
Any Solicited Vomiting Injection 2 4 7
Grade 3 Vomiting ≥ 6 episodes per 24 hours 0 0
Any Solicited Crying Abnormal Injection 2 19 16
Grade 3 Crying Abnormal >3 hours 1 2
Any Solicited Drowsiness Injection 2 13 23
Grade 3 Drowsiness Sleeping most of the time 0 0
Any Solicited Appetite Lost Injection 2 18 17
Grade 3 Appetite Lost refuses most feeds 1 1
Any Solicited Irritability Injection 2 30 30
Grade 3 Irritability inconsolable 3 4
6.Secondary Outcome
Title Number of Participants Reporting a Solicited Injection Site or Systemic Reactions After Each Vaccination With Either a Fluzone Intradermal or a Fluzone Intramuscular Vaccine - Age 3 to 8 Year Olds
Hide Description Solicited injection site reactions: Pain, Redness, Swelling, Induration and Ecchymosis. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia.
Time Frame Day 0 to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety parameters were determined post-vaccination in the safety, intend-to-treat population.
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description:
Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
Overall Number of Participants Analyzed 0 0 160 163
Measure Type: Number
Unit of Measure: Participants
Any injection site Pain Injection 1 93 89
Grade 3 Pain (Reduced movement) 0 0
Any Injection site Redness Injection 1 98 42
Grade 3 Redness ( ≥ 5 cm) 2 1
Any Injection site Swelling Injection 1 59 30
Grade 3 Swelling ( ≥ 5 cm) 1 0
Any Injection site Induration Injection 1 56 25
Grade 3 Induration ( ≥ 5 cm) 1 0
Any Injection site Ecchymosis Injection 1 18 19
Grade 3 Ecchymosis ( ≥ 5 cm) 0 1
Any Solicited Pruritus Injection 1 23 11
Any injection site pain Injection 2 98 90
Grade 3 Pain (Reduced movement) 0 1
Any Injection site Redness Injection 2 94 40
Grade 3 Redness (≥ 5 cm) 1 1
Any Injection site Swelling Injection 2 61 21
Grade 3 swelling ( ≥ 5 cm) 1 0
Any Injection site Induration Injection 2 50 17
Grade 3 Induration (≥ 5 cm) 1 0
Any Injection site Ecchymosis Injection 2 18 22
Grade 3 Ecchymosis (≥ 5 cm) 0 0
Any Solicited Pruritus Injection 2 15 19
Any Solicited Fever Injection 1 10 18
Grade 3 Fever > 102.2°F 2 3
Any Solicited Headache Injection 1 22 25
Grade 3 Headache Prevents daily activities 1 1
Any Solicited Malaise Injection 1 21 30
Grade 3 Malaise Prevents daily activities 1 2
Any Solicited Myalgia Injection 1 24 42
Grade 3 Myalgia Prevents daily activities 0 0
Any Solicited Fever Injection 2 16 14
Grade 3 Fever > 102.2°F 0 2
Any Solicited Headache Injection 2 15 17
Grade 3 Headache Prevents daily activities 2 2
Any Solicited Malaise Injection 2 24 21
Grade 3 Malaise Prevents daily activities 1 1
Any Solicited Myalgia Injection 2 24 25
Grade 3 Myalgia Prevents daily activities 2 0
Time Frame Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination 2
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Hide Arm/Group Description Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
All-Cause Mortality
Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/97 (1.03%)      1/97 (1.03%)      1/160 (0.63%)      1/163 (0.61%)    
Infections and infestations         
Gastroenteritis viral * 1  0/97 (0.00%)  0 1/97 (1.03%)  1 0/160 (0.00%)  0 0/163 (0.00%)  0
Viral infection * 1  0/97 (0.00%)  0 0/97 (0.00%)  0 1/160 (0.63%)  1 0/163 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration * 1  1/97 (1.03%)  1 0/97 (0.00%)  0 0/160 (0.00%)  0 0/163 (0.00%)  0
Nervous system disorders         
Autism * 1  0/97 (0.00%)  0 0/97 (0.00%)  0 0/160 (0.00%)  0 1/163 (0.61%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Group 1: Fluzone ID at Age 6 to 35 Months Group 2: Fluzone IM 6 to 35 Months Age Group Group 3: Fluzone ID at 3 to 8 Years Age Group 4: Fluzone IM 3 to 8 Years Age
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/97 (52.58%)      49/97 (50.52%)      98/160 (61.25%)      90/163 (55.21%)    
Eye disorders         
Conjunctivitis * 1  5/97 (5.15%)  5 6/97 (6.19%)  6 0/160 (0.00%)  0 0/163 (0.00%)  0
Gastrointestinal disorders         
Diarrhoea * 1  7/97 (7.22%)  8 9/97 (9.28%)  9 15/160 (9.38%)  15 3/163 (1.84%)  3
Teething * 1  7/97 (7.22%)  8 6/97 (6.19%)  11 0/160 (0.00%)  0 0/163 (0.00%)  0
Vomiting * 1  3/97 (3.09%)  3 6/97 (6.19%)  6 14/160 (8.75%)  14 12/163 (7.36%)  13
Vomiting  1  5/93 (5.38%)  5 7/86 (8.14%)  7 0/160 (0.00%)  0/163 (0.00%) 
Appetite lost  1  20/93 (21.51%)  20 21/91 (23.08%)  21 0/160 (0.00%)  0/163 (0.00%) 
General disorders         
Pyrexia * 1  8/97 (8.25%)  9 22/97 (22.68%)  27 13/160 (8.13%)  13 14/163 (8.59%)  14
Vessel puncture site bruise * 1  11/97 (11.34%)  12 15/97 (15.46%)  17 11/160 (6.88%)  11 16/163 (9.82%)  19
Injection site Tenderness  1  51/93 (54.84%)  51 49/87 (56.32%)  49 98/137 (71.53%)  98 90/145 (62.07%)  90
Injection site Redness  1  48/93 (51.61%)  48 28/87 (32.18%)  28 98/143 (68.53%)  98 42/151 (27.81%)  42
Injection site Swelling  1  23/88 (26.14%)  23 15/90 (16.67%)  15 61/137 (44.53%)  61 30/151 (19.87%)  30
Injection site Induration  1  24/93 (25.81%)  24 14/87 (16.09%)  14 56/143 (39.16%)  56 25/151 (16.56%)  25
Injection site Ecchymosis  1  23/88 (26.14%)  23 13/87 (14.94%)  13 18/143 (12.59%)  18 22/145 (15.17%)  22
Malaise  1  0/97 (0.00%)  0/97 (0.00%)  24/136 (17.65%)  24 30/150 (20.00%)  30
Myalgia  1  0/97 (0.00%)  0/97 (0.00%)  24/141 (17.02%)  24 42/150 (28.00%)  42
Infections and infestations         
Bronchitis * 1  0/97 (0.00%)  0 5/97 (5.15%)  5 0/160 (0.00%)  0 0/163 (0.00%)  0
Croup infections * 1  4/97 (4.12%)  4 5/97 (5.15%)  5 4/160 (2.50%)  4 3/163 (1.84%)  4
Gastroenteritis * 1  5/97 (5.15%)  5 0/97 (0.00%)  0 4/160 (2.50%)  4 2/163 (1.23%)  2
Nasopharyngitis * 1  14/97 (14.43%)  16 9/97 (9.28%)  11 4/160 (2.50%)  5 18/163 (11.04%)  20
Otitis media * 1  17/97 (17.53%)  19 23/97 (23.71%)  27 8/160 (5.00%)  9 8/163 (4.91%)  8
Sinusitis * 1  4/97 (4.12%)  4 7/97 (7.22%)  7 5/160 (3.13%)  5 4/163 (2.45%)  4
Upper respiratory tract infection * 1  15/97 (15.46%)  17 18/97 (18.56%)  23 9/160 (5.63%)  10 7/163 (4.29%)  10
Viral infection * 1  2/97 (2.06%)  2 5/97 (5.15%)  5 5/160 (3.13%)  5 0/163 (0.00%)  0
Nervous system disorders         
Drowsiness  1  21/93 (22.58%)  21 24/91 (26.37%)  24 0/160 (0.00%)  0/163 (0.00%) 
Irritability  1  37/93 (39.78%)  37 39/91 (42.86%)  39 0/160 (0.00%)  0/163 (0.00%) 
Headache  1  0/97 (0.00%)  0/97 (0.00%)  22/141 (15.60%)  22 25/150 (16.67%)  25
Psychiatric disorders         
Crying abnormal  1  17/93 (18.28%)  17 29/91 (31.87%)  29 0/160 (0.00%)  0/163 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  33/97 (34.02%)  44 32/97 (32.99%)  39 46/160 (28.75%)  60 42/163 (25.77%)  55
Nasal congestion * 1  7/97 (7.22%)  11 4/97 (4.12%)  6 4/160 (2.50%)  5 9/163 (5.52%)  11
Pharyngolaryngeal pain * 1  0/97 (0.00%)  0 2/97 (2.06%)  2 7/160 (4.38%)  8 12/163 (7.36%)  15
Rhinorrhoea * 1  18/97 (18.56%)  24 19/97 (19.59%)  26 19/160 (11.88%)  30 20/163 (12.27%)  26
Skin and subcutaneous tissue disorders         
Pruritus  1  0/97 (0.00%)  0/97 (0.00%)  23/139 (16.55%)  23 19/144 (13.19%)  19
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00391391     History of Changes
Other Study ID Numbers: FID07
First Submitted: October 23, 2006
First Posted: October 24, 2006
Results First Submitted: October 12, 2011
Results First Posted: November 22, 2011
Last Update Posted: December 1, 2011