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Trial record 1 of 1 for:    AL201
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Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

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ClinicalTrials.gov Identifier: NCT00348881
Recruitment Status : Completed
First Posted : July 6, 2006
Results First Posted : October 22, 2013
Last Update Posted : October 22, 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Hepatitis B
Influenza
Interventions Biological: DTaP-HB-PRP~T combined vaccine
Biological: Tritanrix-HepB/Hib™ vaccine
Biological: Oral poliomyelitis vaccine (OPV)
Enrollment 2133
Recruitment Details Participants were enrolled and treated from 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines.
Pre-assignment Details A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
Period Title: Overall Study
Started 1424 709
Completed 1407 697
Not Completed 17 12
Reason Not Completed
Lost to Follow-up             12             6
Withdrawal by Subject             3             4
Adverse Event             2             0
Serious Adverse Event             0             2
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV Total
Hide Arm/Group Description Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. Total of all reporting groups
Overall Number of Baseline Participants 1424 709 2133
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1424 participants 709 participants 2133 participants
<=18 years
1424
 100.0%
709
 100.0%
2133
 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:  Weeks
Number Analyzed 1424 participants 709 participants 2133 participants
6.27  (0.280) 6.30  (0.310) 6.28  (0.291)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1424 participants 709 participants 2133 participants
Female
718
  50.4%
356
  50.2%
1074
  50.4%
Male
706
  49.6%
353
  49.8%
1059
  49.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Philippines Number Analyzed 1424 participants 709 participants 2133 participants
1424 709 2133
1.Primary Outcome
Title Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description

Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria.

Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.

Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 246 123
Measure Type: Number
Unit of Measure: Participants
Anti-Hep Bs (N = 246, 122) 239 119
Anti-PRP (N = 218, 122) 210 121
Anti-Diphtheria (N = 246, 123) 217 109
Anti-Tetanus (N = 246,123) 246 123
2.Primary Outcome
Title Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Hide Description Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Time Frame Day 0 to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 1425 708
Measure Type: Number
Unit of Measure: Participants
Post-any Vaccination (N = 1419, 705) 5 8
Post-vaccination 1 (N = 1419, 705) 3 1
Post-vaccination 2 (N = 1408, 698) 1 3
Post-vaccination 3 (N = 1405, 698) 1 4
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description Immunogenicity was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
Time Frame 1 month post third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed in a subset of the participants available for the endpoint, the per-protocol population.
Arm/Group Title Group 1: DTaP-Hep B-PRP-T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
Overall Number of Participants Analyzed 246 123
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hep Bs (N = 246, 122)
464
(380 to 567)
343
(265 to 444)
Anti-PRP (N = 218, 121)
3.02
(2.47 to 3.69)
10.3
(8.30 to 12.8)
Anti-Diphtheria (N = 246, 123)
0.025
(0.022 to 0.028)
0.023
(0.019 to 0.028)
Anti-Tetanus (N = 246, 123)
1.05
(0.958 to 1.14)
1.31
(1.14 to 1.49)
Anti-Pertusiss (N = 245, 108)
139
(127 to 152)
81.5
(57.3 to 116)
Anti-Filamentous Hemagglutinin (N = 205, 94)
86.7
(80.0 to 93.9)
9.17
(7.33 to 11.5)
4.Secondary Outcome
Title Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Hide Description

Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability.

Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.

Time Frame Day 0 to Day 7 after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description:
Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
Overall Number of Participants Analyzed 1425 708
Measure Type: Number
Unit of Measure: Participants
Injection site Pain post any vaccination 1092 636
Grade 3 Injection site Pain post any vaccination 344 295
Injection site Pain Post-vaccination 1 958 573
Injection site Pain Post-vaccination 2 751 463
Injection site Pain Post-vaccination 3 616 407
Injection site Erythema Post any vaccination 794 497
Grade 3 Inject. site Erythema Post any vaccination 16 16
Injection site Erythema Post-vaccination 1 543 353
Injection site Erythema Post-vaccination 2 448 320
Injection site Erythema Post-vaccination 3 408 283
Injection site Swelling Post any vaccination 719 503
Grade 3 Inject. site Swelling Post any vaccination 15 35
Injection site Swelling Post-vaccination 1 576 423
Injection site Swelling Post-vaccination 2 438 343
Injection site Swelling Post-vaccination 3 365 288
Fever Post any vaccination 523 394
Grade 3 Fever Post any vaccination 5 8
Fever Post-vaccination 1 282 248
Fever Post-vaccination 2 222 165
Fever Post-vaccination 3 187 156
Vomiting Post any vaccination 266 172
Grade 3 Vomiting Post any vaccination 2 3
Vomiting Post-vaccination 1 193 118
Vomiting Post-vaccination 2 105 83
Vomiting Post-vaccination 3 72 52
Crying post any vaccination 567 381
Grade 3 Crying post any vaccination 5 0
Crying post-vaccination 1 431 301
Crying post-vaccination 2 275 193
Crying post-vaccination 3 205 152
Somnolence post any vaccination 673 360
Grade 3 Somnolence post any vaccination 43 35
Somnolence post-vaccination 1 527 282
Somnolence post-vaccination 2 368 216
Somnolence post-vaccination 3 255 150
Anorexia post any vaccination 396 250
Grade 3 Anorexia post any vaccination 10 8
Anorexia post-vaccination 1 235 159
Anorexia post-vaccination 2 201 118
Anorexia post-vaccination 3 130 97
Irritability post any vaccination 945 539
Grade 3 Irritability post any vaccination 33 32
Irritability post-vaccination 1 823 471
Irritability post-vaccination 2 499 331
Irritability post-vaccination 3 369 266
Time Frame Adverse event data were collected from Day 0 (post-vaccination) up to Day 238 post-vaccination.
Adverse Event Reporting Description Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The safety data were analyzed and presented according to the actual treatment received.
 
Arm/Group Title Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Hide Arm/Group Description Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
All-Cause Mortality
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   31/1425 (2.18%)      12/708 (1.69%)    
Blood and lymphatic system disorders     
Idiopathic thrombocytopenia purpura * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Cardiac disorders     
Cardiac disorder * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
General disorders     
Pyrexia * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Infections and infestations     
Amoebic dysentery * 1  2/1425 (0.14%)  2 0/708 (0.00%)  0
Bronchitis * 1  2/1425 (0.14%)  2 0/708 (0.00%)  0
Bronchopneumonia * 1  1/1425 (0.07%)  1 2/708 (0.28%)  2
Diarrhoea infectious * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Gastroenteritis * 1  9/1425 (0.63%)  9 3/708 (0.42%)  3
Meningitis * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Pneumonia * 1  13/1425 (0.91%)  13 5/708 (0.71%)  5
Pneumonia primary atypical * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Sepsis * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Sepsis neonatal * 1  0/1425 (0.00%)  0 1/708 (0.14%)  1
Urinary tract infection * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Injury, poisoning and procedural complications     
Thermal burn * 1  1/1425 (0.07%)  1 0/708 (0.00%)  0
Nervous system disorders     
Convlusion * 1  0/1425 (0.00%)  0 1/708 (0.14%)  1
Febrile convulsion * 1  0/1425 (0.00%)  0 1/708 (0.14%)  1
*
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 5.00%
Group 1: DTaP-Hep B-PRP~T + OPV Group 2: Tritanrix-Hep B/ Hib™ + OPV
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1092/1425 (76.63%)      636/708 (89.83%)    
Gastrointestinal disorders     
Vomiting * 1  193/1425 (13.54%)  118/708 (16.67%) 
General disorders     
Solicited injection site Pain  1  958/1425 (67.23%)  573/708 (80.93%) 
Solicited injection site Erythema  1  543/1425 (38.11%)  353/708 (49.86%) 
Solicited injection site Swelling  1  576/1425 (40.42%)  423/708 (59.75%) 
Pyrexia  1  282/1425 (19.79%)  248/708 (35.03%) 
Infections and infestations     
Upper respiratory tract infection * 1  481/1425 (33.75%)  210/708 (29.66%) 
Rhinitis * 1  93/1425 (6.53%)  44/708 (6.21%) 
Metabolism and nutrition disorders     
Anorexia  1  235/1425 (16.49%)  159/708 (22.46%) 
Nervous system disorders     
Somnolence  1  527/1425 (36.98%)  282/708 (39.83%) 
Psychiatric disorders     
Crying  1  431/1425 (30.25%)  301/708 (42.51%) 
Irritability  2  823/1425 (57.75%)  471/708 (66.53%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
2
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: NCT00348881     History of Changes
Other Study ID Numbers: AL201
First Submitted: July 5, 2006
First Posted: July 6, 2006
Results First Submitted: June 10, 2013
Results First Posted: October 22, 2013
Last Update Posted: October 22, 2013