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Trial record 1 of 1 for:    M5A10
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Safety and Immune Response of Different Pediatric Combination Vaccines.

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ClinicalTrials.gov Identifier: NCT00255047
Recruitment Status : Completed
First Posted : November 17, 2005
Results First Posted : November 10, 2010
Last Update Posted : February 14, 2014
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
Polio
Pertussis
Interventions Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
Biological: Pentacel®: DTaP-IPV/Hib combined
Biological: DTaP-IPV and ActHIB®
Enrollment 2167
Recruitment Details Participants were enrolled from 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.
Pre-assignment Details A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Period Title: Overall Study
Started 538 535 546 548
Completed 490 487 496 502
Not Completed 48 48 50 46
Reason Not Completed
Serious Adverse Events             2             1             2             1
Adverse Event             0             3             2             1
Protocol Violation             13             13             16             20
Lost to Follow-up             9             8             5             6
Withdrawal by Subject             24             23             25             18
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel® Total
Hide Arm/Group Description Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. Total of all reporting groups
Overall Number of Baseline Participants 538 535 546 548 2167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 538 participants 535 participants 546 participants 548 participants 2167 participants
<=18 years
538
 100.0%
535
 100.0%
546
 100.0%
548
 100.0%
2167
 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 538 participants 535 participants 546 participants 548 participants 2167 participants
2.2  (0.27) 2.1  (0.27) 2.2  (0.27) 2.1  (0.28) 2.1  (0.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 538 participants 535 participants 546 participants 548 participants 2167 participants
Female
251
  46.7%
242
  45.2%
249
  45.6%
274
  50.0%
1016
  46.9%
Male
287
  53.3%
293
  54.8%
297
  54.4%
274
  50.0%
1151
  53.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 538 participants 535 participants 546 participants 548 participants 2167 participants
538 535 546 548 2167
1.Primary Outcome
Title Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Hide Description Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer > LLOQ; or a pre-dose 1 titer > LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Time Frame 30 Days post-dose 3 vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The vaccine response to pertussis antigens were determined in the per-protocol population.
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description:
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Overall Number of Participants Analyzed 419 405 411 424
Measure Type: Number
Unit of Measure: Percentage of Participants
Pertussis Toxoid (PT) 98 99 99 99
Filamentous Haemagglutinin (FHA) 86 96 95 96
Pertactin (PRN) 94 92 94 92
Fimbriae Types 2 and 3 (FIM) 97 96 99 97
2.Primary Outcome
Title Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Hide Description [Not Specified]
Time Frame 30 Days post-dose 3 vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Four-fold rise titers (seroconversion) were evaluated in the per-protocol population
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description:
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Overall Number of Participants Analyzed 419 405 411 424
Measure Type: Number
Unit of Measure: Percentage of participants
Pertussis Toxoid (PT) 89 92 92 92
Filamentous Haemagglutinin (FHA) 54 75 77 77
Pertactin (PRN) 71 67 76 68
Fimbriae Types 2 and 3 (FIM) 86 85 94 90
3.Primary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Hide Description [Not Specified]
Time Frame 30 Days post-dose 3 vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were evaluated in the per-protocol immunogenicity population
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description:
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Overall Number of Participants Analyzed 422 406 414 425
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Pertussis Toxoid (EU/mL)
66.48
(62.54 to 70.67)
96.8
(91.4 to 102.4)
116.86
(110.60 to 123.47)
97.8
(92.5 to 103.3)
Filamentous Haemagglutinin (EU/mL)
22.51
(20.94 to 24.20)
53.0
(49.7 to 56.6)
56.88
(53.26 to 60.74)
54.1
(50.9 to 57.4)
Pertactin (EU/mL)
33.63
(30.92 to 36.58)
32.5
(29.5 to 35.9)
44.70
(40.95 to 48.80)
32.5
(29.5 to 35.8)
Fimbriae Types 2 and 3 (EU/mL)
181.66
(166.62 to 198.06)
188.5
(173.9 to 204.3)
273.10
(254.83 to 292.67)
199.0
(184.3 to 214.8)
Polyribosylribitol Phosphate-Tetanus Toxoid; μg/mL
2.38
(2.01 to 2.81)
2.5
(2.2 to 2.9)
3.76
(3.25 to 4.34)
2.5
(2.2 to 2.9)
Diphtheria (IU/mL)
0.32
(0.29 to 0.36)
0.3
(0.3 to 0.4)
0.37
(0.33 to 0.41)
0.3
(0.3 to 0.3)
Tetanus toxoid (IU/mL, ≥ 0.01)
0.97
(0.91 to 1.04)
0.8
(0.7 to 0.8)
1.09
(1.02 to 1.17)
0.8
(0.7 to 0.8)
Poliovirus Types 1 (≥ 1:8 dil)
719.83
(645.73 to 802.42)
397.7
(342.8 to 461.5)
776.44
(676.85 to 890.68)
468.3
(406.3 to 539.8)
Poliovirus Types 2 (≥ 1:8 dil)
734.50
(668.28 to 807.28)
699.5
(623.6 to 784.6)
1203.20
(1082.31 to 1337.60)
812.5
(727.3 to 907.7)
Poliovirus Types 3 (≥ 1:8 dil)
916.90
(829.15 to 1013.92)
666.6
(584.7 to 760.0)
1115.00
(976.11 to 1273.65)
819.9
(715.8 to 939.0)
4.Other Pre-specified Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3
Hide Description Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Time Frame 7 days post-vaccination 3
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were evaluated in the intend-to-treat (ITT) population
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description:
Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Overall Number of Participants Analyzed 538 535 546 548
Measure Type: Number
Unit of Measure: Participants
Any Solicited Injection Site Reaction 203 160 164 160
Any Erythema 34 28 21 18
Grade 3 Erythema Any dose (>50 mm) 0 1 0 0
Any Swelling 12 18 10 14
Grade 3 Swelling Any dose (>50 mm) 0 1 0 0
Any Tenderness 186 152 150 148
Grd 3 Tenderness (cries when inj. limb is moved) 11 4 6 4
Any Solicited Systemic Reaction 311 303 328 309
Any Fever 102 102 124 94
Grade 3 Fever (> 39.5 C) 3 4 7 1
Any Vomitting 49 40 41 42
Grade 3 Vomitting (≥3 episodes) 9 3 3 7
Any Anormal crying 144 114 125 133
Grade 3 Abnormal crying (Inconsolable > 3 hrs) 3 1 2 4
Any Lethargy 114 97 100 91
Grade 3 Lethargy (disabling) 4 0 4 0
Any Appetite decreased 84 72 85 65
Grade 3 Appetite decreased (skips ≥ 2 meals) 4 0 3 1
Any Irritability 242 239 254 242
Grade 3 Irritability (continuously for >3 hours) 5 12 11 11
Time Frame Adverse events data were collected for 4 months post-vaccination 1 (Stage I)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Hide Arm/Group Description Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively. Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively. Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
All-Cause Mortality
Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/538 (3.35%)      18/535 (3.36%)      21/546 (3.85%)      11/548 (2.01%)    
Congenital, familial and genetic disorders         
Congenital aortic anomaly * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Congenital ventricular septal defect * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Hepatic arteriovenous malformation * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
Gastrointestinal disorders         
Acquired pyloric stenosis * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Intussusception * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
General disorders         
Pyrexia * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 1/548 (0.18%)  1
Sudden infant death syndrome * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Upper extremity mass * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Infections and infestations         
Abscess limb * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Bronchiolitis * 1  7/538 (1.30%)  7 4/535 (0.75%)  4 6/546 (1.10%)  6 3/548 (0.55%)  3
Croup infectious * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 0/546 (0.00%)  0 2/548 (0.36%)  2
Gastroenteritis * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 3/546 (0.55%)  3 1/548 (0.18%)  1
Gastroenteritis rotavirus * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Gastroenteritis viral * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
Hand-foot-and-mouth disease * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Influenza * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Kawasaki´s disease * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Lobar pneumonia * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 1/546 (0.18%)  1 0/548 (0.00%)  0
Meningitis viral * 1  2/538 (0.37%)  2 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Otitis media * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Pneumonia * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Pyelonephritis * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Sepsis * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
Urinary tract infection * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Viral infection * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 2/546 (0.37%)  2 1/548 (0.18%)  1
Injury, poisoning and procedural complications         
Subdural haematoma * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Metabolism and nutrition disorders         
Dehydration * 1  1/538 (0.19%)  1 2/535 (0.37%)  2 2/546 (0.37%)  2 1/548 (0.18%)  1
Failure to thrive * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
General nutrition disorder * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Hyponatraemia * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Nervous system disorders         
Convulsion * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 3/546 (0.55%)  4 1/548 (0.18%)  3
Dyskinesia * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Hypotonia * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Hypotonic-hyporesponsive episode * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 1/546 (0.18%)  1 0/548 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Apnoea * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
Asthma * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Choking * 1  1/538 (0.19%)  1 0/535 (0.00%)  0 0/546 (0.00%)  0 0/548 (0.00%)  0
Laryngeal stenosis * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
Respiratory distress * 1  2/538 (0.37%)  2 1/535 (0.19%)  1 1/546 (0.18%)  1 0/548 (0.00%)  0
Respiratory failure * 1  0/538 (0.00%)  0 0/535 (0.00%)  0 0/546 (0.00%)  0 1/548 (0.18%)  1
Skin and subcutaneous tissue disorders         
Eczema * 1  0/538 (0.00%)  0 1/535 (0.19%)  1 0/546 (0.00%)  0 0/548 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Study Group 1: DAPTACEL®, IPOL®, and ActHIB® Study Group 2: Pentacel® Study Group 3: DTaP-IPV and ActHIB® Study Group 4: Pentacel®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   399/538 (74.16%)      394/535 (73.64%)      421/546 (77.11%)      414/548 (75.55%)    
Gastrointestinal disorders         
Diarrhoea * 1  39/538 (7.25%)  44 34/535 (6.36%)  37 41/546 (7.51%)  43 41/548 (7.48%)  43
Teething * 1  35/538 (6.51%)  44 33/535 (6.17%)  43 30/546 (5.49%)  40 34/548 (6.20%)  48
Vomiting  1  128/532 (24.06%)  169 119/533 (22.33%)  153 131/538 (24.35%)  174 119/543 (21.92%)  150
General disorders         
Pyrexia * 1  27/538 (5.02%)  35 33/535 (6.17%)  34 22/546 (4.03%)  25 25/548 (4.56%)  27
Injection site erythema  1  90/532 (16.92%)  174 65/533 (12.20%)  83 64/538 (11.90%)  107 66/543 (12.15%)  82
Injection site swelling  1  49/532 (9.21%)  102 50/533 (9.38%)  59 43/538 (7.99%)  77 49/543 (9.02%)  71
Injection site pain  1  342/532 (64.29%)  1406 310/533 (58.16%)  545 301/538 (55.95%)  967 310/543 (57.09%)  542
Fever  1  219/531 (41.24%)  300 199/533 (37.34%)  254 221/537 (41.15%)  304 208/543 (38.31%)  268
Lethargy  1  271/532 (50.94%)  456 275/533 (51.59%)  415 262/538 (48.70%)  415 239/543 (44.01%)  369
Infections and infestations         
Bronchiolitis * 1  24/538 (4.46%)  27 34/535 (6.36%)  37 28/546 (5.13%)  30 16/548 (2.92%)  17
Otitis media * 1  72/538 (13.38%)  86 97/535 (18.13%)  117 93/546 (17.03%)  109 75/548 (13.69%)  94
Upper respiratory tract infection * 1  143/538 (26.58%)  164 141/535 (26.36%)  167 134/546 (24.54%)  162 141/548 (25.73%)  167
Viral infection * 1  16/538 (2.97%)  17 31/535 (5.79%)  32 20/546 (3.66%)  22 23/548 (4.20%)  23
Metabolism and nutrition disorders         
Appetite Decreased  1  214/532 (40.23%)  295 191/533 (35.83%)  253 192/538 (35.69%)  267 174/543 (32.04%)  251
Psychiatric disorders         
Anbormal crying  1  287/532 (53.95%)  495 282/533 (52.91%)  446 275/539 (51.02%)  452 285/543 (52.49%)  442
Irritability  1  399/532 (75.00%)  820 394/533 (73.92%)  795 421/539 (78.11%)  820 414/543 (76.24%)  800
Respiratory, thoracic and mediastinal disorders         
Cough * 1  37/538 (6.88%)  42 49/535 (9.16%)  54 45/546 (8.24%)  51 44/548 (8.03%)  47
Nasal congestion * 1  51/538 (9.48%)  59 49/535 (9.16%)  57 50/546 (9.16%)  59 42/548 (7.66%)  46
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00255047     History of Changes
Other Study ID Numbers: M5A10
First Submitted: November 15, 2005
First Posted: November 17, 2005
Results First Submitted: September 14, 2010
Results First Posted: November 10, 2010
Last Update Posted: February 14, 2014