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Trial record 1 of 1 for:    A3L02
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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

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ClinicalTrials.gov Identifier: NCT00831311
Recruitment Status : Completed
First Posted : January 28, 2009
Results First Posted : November 21, 2013
Last Update Posted : December 17, 2013
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type b
Poliomyelitis
Interventions Biological: DTaP-IPV-HB-PRP~T
Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
Enrollment 624
Recruitment Details Participants were enrolled and treated from 26 October 2004 to 10 November 2005 in 1 clinical center in Argentina.
Pre-assignment Details A total of 624 participants who met the inclusion but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age. Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Period Title: Overall Study
Started 312 312
Completed 300 304
Not Completed 12 8
Reason Not Completed
Definitive Contraindication             3             3
Lost to Follow-up             3             0
Physician Decision             0             1
Withdrawal by Subject             6             4
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B® Total
Hide Arm/Group Description Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age. Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age. Total of all reporting groups
Overall Number of Baseline Participants 312 312 624
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 312 participants 312 participants 624 participants
<=18 years
312
 100.0%
312
 100.0%
624
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 312 participants 312 participants 624 participants
1.76  (0.12) 1.77  (0.11) 1.76  (0.11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 312 participants 312 participants 624 participants
Female
148
  47.4%
147
  47.1%
295
  47.3%
Male
164
  52.6%
165
  52.9%
329
  52.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Argentina Number Analyzed 312 participants 312 participants 624 participants
312 312 624
1.Primary Outcome
Title Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Hide Description Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Time Frame 1 month post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 260 271
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Pertussis toxoid (N = 233, 241) 92 93
Anti-Filamentous hemagglutinin (N = 250, 249) 93 90
2.Primary Outcome
Title Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Hide Description

Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.

Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.

Time Frame Day 150 (1 month post-vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection to the vaccine antigens was assessed in the per-protocol population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 260 271
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Hepatitis B (N = 258, 271) 99 100
Anti-PRP (N = 260, 270) 95 97
Anti-Tetanus (N = 260, 271) 100 100
Anti-Diphtheria (N = 260, 271) 100 100
Anti-Polio Type 1 (N = 259, 268) 100 100
Anti-Polio Type 2 (N = 257, 269) 100 100
Anti-Polio Type 3 (N = 257, 263) 100 100
3.Primary Outcome
Title Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Hide Description Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Time Frame Day 150 (1 month post-vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to the vaccine antigens were assessed in the per-protocol population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 260 271
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0 (N = 256, 267)
1.14
(0.960 to 1.36)
1.16
(0.989 to 1.37)
Day 150 (N = 260, 271)
2.29
(2.09 to 2.51)
1.79
(1.66 to 1.92)
4.Primary Outcome
Title Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Hide Description Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Time Frame Day 150 (1 month post-vaccination 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers to the Polio Antigens were assessed in the per-protocol population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 260 271
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio Type 1 Day 0 (N = 250, 258)
7.41
(6.34 to 8.65)
7.04
(6.08 to 8.15)
Anti-Polio Type 1 Day 150 (N = 259, 268)
4091
(3452 to 4848)
4198
(3595 to 4901)
Anti-Polio Type 2 Day 0 (N = 249, 261)
11.5
(9.72 to 13.7)
10.5
(9.02 to 12.1)
Anti-Polio Type 2 Day 150 (N = 257, 269)
3244
(2757 to 3817)
3223
(2753 to 3773)
Anti-Polio Type 3 Day 0 (N = 246, 254)
6.89
(6.09 to 7.81)
6.77
(6.04 to 7.60)
Anti-Polio Type 3 Day 150 (N = 257, 263)
3839
(3197 to 4610)
5502
(4608 to 6570)
5.Secondary Outcome
Title Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Hide Description Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intent-to- treat) population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 311 312
Measure Type: Number
Unit of Measure: Participants
Any Injection site Erythema Post-vaccination 1 120 89
Grade 3 Erythema (≥ 5 cm) Post-vaccination 1 6 2
Any Injection site Erythema Post-vaccination 2 138 107
Grade 3 Erythema (≥ 5 cm) Post-vaccination 2 6 0
Any Injection site Erythema Post-vaccination 3 143 115
Grade 3 Erythema (≥ 5 cm) Post-vaccination 3 7 4
Any Injection site Edema Post-vaccination 1 97 62
Grade 3 Edema (≥ 5 cm) Post-vaccination 1 10 0
Any Injection site Edema Post-vaccination 2 88 72
Grade 3 Edema (≥ 5 cm) Post-vaccination 2 4 1
Any Injection site Edema Post-vaccination 3 100 73
Grade 3 Edema (≥ 5 cm) Post-vaccination 3 3 3
Any Injection site Induration Post-vaccination 1 140 100
Grade 3 Induration (≥ 5 cm) Post-vaccination 1 6 0
Any Injection site Induration Post-vaccination 2 123 99
Grade 3 Induration (≥ 5 cm) Post-vaccination 2 3 1
Any Injection site Induration Post-vaccination 3 125 106
Grade 3 Induration (≥ 5 cm) Post-vaccination 3 2 4
Any Injection site Pain Post-vaccination 1 195 138
Grade 3 Pain (Cries when moved) Post-vaccination 1 83 34
Any Injection site Pain Post-vaccination 2 139 115
Grade 3 Pain (Cries when moved) Post-vaccination 2 36 13
Any Injection site Pain Post-vaccination 3 126 105
Grade 3 Pain (Cries when moved) Post-vaccination 3 15 8
6.Secondary Outcome
Title Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Hide Description Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intend-to-treat) population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 311 312
Measure Type: Number
Unit of Measure: Participants
Any Injection site Erythema Post-vaccination 1 120 59
Grade 3 Erythema (≥5 cm) Post-vaccination 1 6 0
Any Injection site Erythema Post-vaccination 2 138 56
Grade 3 Erythema (≥5 cm) Post-vaccination 2 6 1
Any Injection site Erythema Post-vaccination 3 143 67
Grade 3 Erythema (≥5 cm) Post-vaccination 3 7 0
Any Injection site Edema Post-vaccination 1 97 43
Grade 3 Edema (≥ 5 cm) Post-vaccination 1 10 0
Any Injection site Edema Post-vaccination 2 88 37
Grade 3 Edema (≥5 cm) Post-vaccination 2 4 0
Any Injection site Edema Post-vaccination 3 100 42
Grade 3 Edema (≥ 5 cm) Post-vaccination 3 3 0
Any Injection site Induration Post-vaccination 1 140 45
Grade 3 Induration (≥ 5 cm) Post-vaccination 1 6 0
Any Injection site Induration Post-vaccination 2 123 41
Grade 3 Induration (≥ 5 cm) Post-vaccination 2 3 0
Any Injection site Induration Post-vaccination 3 125 51
Grade 3 Induration (≥5 cm) Post-vaccination 3 2 0
Any Injection site Pain Post-vaccination 1 195 123
Grade 3 Pain (Cries when moved) Post-vaccination 1 83 26
Any Injection site Pain Post-vaccination 2 139 88
Grade 3 Pain (Cries when moved) Post-vaccination 2 36 11
Any Injection site Pain Post-vaccination 3 126 84
Grade 3 Pain (Cries when moved) Post-vaccination 3 15 6
7.Secondary Outcome
Title Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Hide Description

Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.

Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intent-to- treat) population.
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
Overall Number of Participants Analyzed 311 312
Measure Type: Number
Unit of Measure: Participants
Any Pyrexia Post-vaccination 1 (N = 311, 312) 116 71
Grade 3 Pyrexia Post-vaccination 1 (N = 311, 312) 0 0
Any Pyrexia Post-vaccination 2 (N = 302, 307) 95 84
Grade 3 Pyrexia Post-vaccination 2 (N = 302, 307) 1 1
Any Pyrexia Post-vaccination 3 (N = 300, 304) 99 83
Grade 3 Pyrexia Post-vaccination 3 (N = 300, 304) 3 2
Any Somnolence Post-vaccination 1 (N = 311, 312) 143 109
Grade 3 Somnolence Post-vaccination 1 (N=311, 312) 63 48
Any Somnolence Post-vaccination 2 (N = 302, 307) 87 73
Grade 3 Somnolence Post-vaccination 2 (N=302, 307) 18 13
Any Somnolence Post-vaccination 3 (N = 300, 304) 85 65
Grade 3 Somnolence Post-vaccination 3 (N=300, 304) 22 14
Any Irritability Post-vaccination 1 (N = 311, 312) 161 134
Grade 3 Irritability Post-vaccination 1; N=311,312 0 0
Any Irritability Post-vaccination 2 (N = 302, 307) 129 112
Grade 3 Irritability Post-vaccination 2; N=302,307 13 7
Any Irritability Post-vaccination 3 (N = 300, 304) 115 97
Grade 3 Irritability Post-vaccination 3; N=300,304 11 6
Any Anorexia Post-vaccination 1 (N = 311, 312) 78 72
Grade 3 Anorexia Post-vaccination 1 (N = 311, 312) 4 2
Any Anorexia Post-vaccination 2 (N = 302, 307) 68 52
Grade 3 Anorexia Post-vaccination 2 (N = 302, 307) 5 4
Any Anorexia Post-vaccination 3 (N = 300, 304) 80 53
Grade 3 Anorexia Post-vaccination 3 (N = 300, 304) 12 2
Any Vomiting NOS Post-vaccination 1 (N = 311, 312) 56 61
Grade 3 Vomiting NOS Post-vaccination 1: N=311,312 2 3
Any Vomiting NOS Post-vaccination 2 (N = 302, 307) 34 41
Grade 3 Vomiting NOS Post-vaccination 2: N=302,307 2 1
Any Vomiting NOS Post-vaccination 3 (N = 300, 304) 42 23
Grade 3 Vomiting NOS Post-vaccination 3: N=300,304 2 0
Any Diarrhea NOS Post-vaccination 1 (N = 311, 312) 68 60
Grade 3 Diarrhea NOS Post-vaccination 1: N=311,312 10 6
Any Diarrhea NOS Post-vaccination 2 (N = 302, 307) 51 43
Grade 3 Diarrhea NOS Post-vaccination 2: N=302,307 2 2
Any Diarrhea NOS Post-vaccination 3 (N = 300, 304) 33 31
Grade 3 Diarrhea NOS Post-vaccination 3: N=300,304 3 2
Crying Post-vaccination 1 (N = 311, 312) 152 113
Grade 3 Crying Post-vaccination 1 (N = 311, 312) 9 1
Any Crying Post-vaccination 2 (N = 302, 307) 104 89
Grade 3 Crying Post-vaccination 2 (N = 302, 307) 1 2
Any Crying Post-vaccination 3 (N = 300, 304) 78 71
Grade 3 Crying Post-vaccination 3 (N = 300, 304) 2 1
Time Frame Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Hide Arm/Group Description Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age. Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
All-Cause Mortality
Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   19/311 (6.11%)      22/312 (7.05%)    
General disorders     
Pyrexia * 1  1/311 (0.32%)  1 1/312 (0.32%)  1
Infections and infestations     
Bronchiolitis * 1  9/311 (2.89%)  9 6/312 (1.92%)  6
Bronchitis * 1  0/311 (0.00%)  0 3/312 (0.96%)  3
Gastroenteritis * 1  3/311 (0.96%)  3 3/312 (0.96%)  3
Pneumonia * 1  4/311 (1.29%)  4 3/312 (0.96%)  3
Pneumonia viral * 1  0/311 (0.00%)  0 1/312 (0.32%)  1
Urinary Tract Infection * 1  0/311 (0.00%)  0 3/312 (0.96%)  3
Injury, poisoning and procedural complications     
Head Injury * 1  1/311 (0.32%)  1 1/312 (0.32%)  1
Skull Fracture * 1  1/311 (0.32%)  1 0/312 (0.00%)  0
Nervous system disorders     
Convulsion * 1  0/311 (0.00%)  0 2/312 (0.64%)  2
Encephalitis * 1  1/311 (0.32%)  1 0/312 (0.00%)  0
Febrile Convulsion * 1  0/311 (0.00%)  0 1/312 (0.32%)  1
Reproductive system and breast disorders     
Apnea * 1  1/311 (0.32%)  1 0/312 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: DTaP-IPV-Hep B-PRP~T Group 2: PENTAXIM™ and ENGERIX B®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   305/311 (98.07%)      307/312 (98.40%)    
Gastrointestinal disorders     
Diarrhea Not Otherwise Specified  1  119/311 (38.26%)  119 119/312 (38.14%)  119
Vomiting Not Otherwise Specified  1  112/311 (36.01%)  112 110/312 (35.26%)  110
General disorders     
Injection Site Erythemia  1  213/311 (68.49%)  213 194/312 (62.18%)  194
Injection Site Induration  1  215/311 (69.13%)  215 186/312 (59.62%)  186
Injection Site Edema  1  172/311 (55.31%)  172 140/312 (44.87%)  140
Injection Site Pain  1  242/311 (77.81%)  242 202/312 (64.74%)  202
Pyrexia  1  209/311 (67.20%)  209 177/312 (56.73%)  177
Bronchiolitis * 1  24/311 (7.72%)  24 27/312 (8.65%)  27
Infections and infestations     
Pharyngitis * 1  23/311 (7.40%)  23 20/312 (6.41%)  20
Metabolism and nutrition disorders     
Anorexia  1  146/311 (46.95%)  146 138/312 (44.23%)  138
Nervous system disorders     
Somnolence  1  195/311 (62.70%)  195 156/312 (50.00%)  156
Psychiatric disorders     
Crying  1  197/311 (63.34%)  197 178/312 (57.05%)  178
Irritability  1  218/311 (70.10%)  218 193/312 (61.86%)  193
Respiratory, thoracic and mediastinal disorders     
Bronchitis Not Otherwise Specified * 1  33/311 (10.61%)  33 42/312 (13.46%)  42
Rhinitis Not Otherwise Specified * 1  29/311 (9.32%)  29 28/312 (8.97%)  28
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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 ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00831311     History of Changes
Other Study ID Numbers: A3L02
First Submitted: January 27, 2009
First Posted: January 28, 2009
Results First Submitted: September 19, 2013
Results First Posted: November 21, 2013
Last Update Posted: December 17, 2013