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Trial record 1 of 1 for:    A3L17
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Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants

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ClinicalTrials.gov Identifier: NCT00831753
Recruitment Status : Completed
First Posted : January 29, 2009
Results First Posted : April 2, 2014
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type b
Hepatitis B
Interventions Biological: DTaP IPV HB PRP~T vaccine
Biological: DTaP-HB-IPV and Haemophilus influenzae type b
Enrollment 263
Recruitment Details Participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru.
Pre-assignment Details A total of 263 participants who met the inclusion and exclusion criteria were randomized and vaccinated in the study.
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
Period Title: Overall Study
Started 132 131
Completed 132 131
Not Completed 0 0
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group Total
Hide Arm/Group Description All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively. Total of all reporting groups
Overall Number of Baseline Participants 132 131 263
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 131 participants 263 participants
<=18 years
132
 100.0%
131
 100.0%
263
 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 132 participants 131 participants 263 participants
1.75  (0.132) 1.72  (0.123) 1.74  (0.128)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 131 participants 263 participants
Female
58
  43.9%
74
  56.5%
132
  50.2%
Male
74
  56.1%
57
  43.5%
131
  49.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Peru Number Analyzed 132 participants 131 participants 263 participants
132 131 263
1.Primary Outcome
Title Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
Hide Description Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Time Frame Day 150 (1 month after dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description:
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
Overall Number of Participants Analyzed 132 130
Measure Type: Number
Unit of Measure: Participants
131 130
2.Primary Outcome
Title Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Hide Description

Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as:

Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL.

Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.

Time Frame Day 150 (1 month after dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description:
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
Overall Number of Participants Analyzed 132 130
Measure Type: Number
Unit of Measure: Participants
Anti-Hep B (Criteria 1) 131 130
Anti-Hep B (Criteria 2) 124 129
Anti-PRP (Criteria 1) 132 129
Anti-PRP (Criteria 2) 112 109
Anti-Diphtheria (Criteria 1) 126 130
Anti-Diphtheria (Criteria 2) 77 85
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Hide Description Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
Time Frame Day 150 (1 month after dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description:
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
Overall Number of Participants Analyzed 132 130
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers (1/dilutions)
Anti Hep B
986
(764 to 1270)
1139
(961 to 1350)
Anti PRP
5.22
(4.04 to 6.73)
3.93
(3.17 to 4.89)
Anti Diphtheria
0.156
(0.119 to 0.204)
0.192
(0.154 to 0.239)
4.Secondary Outcome
Title Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Hide Description

Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.

Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia > 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable.

Time Frame Day 0 up to Day 7 after each injection
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description:
All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
Overall Number of Participants Analyzed 132 131
Measure Type: Number
Unit of Measure: Participants
Pain Post Injection 1 82 71
Pain Post Injection 2 68 68
Pain Post Injection 3 53 55
Grade 3 Pain Post Any Injection 10 6
Erythema Post Injection 1 32 16
Erythema Post Injection 2 48 30
ErythemaPost Injection 3 45 46
Grade 3 Erythema Post Any Injection 3 5
Swelling Post Injection 1 34 12
Swelling Post Injection 2 26 24
Swelling Post Injection 3 28 32
Grade 3 Swelling Post Any Injection 3 2
Pyrexia Post Injection 1 11 11
Pyrexia Post Injection 2 21 17
Pyrexia Post Injection 3 18 18
Gade 3 Pyrexia Post Any Injection 0 3
Any Vomiting Post Injection 1 20 24
Any Vomiting Post Injection 2 8 6
Vomiting Post Injection 3 6 10
Grade 3 Vomiting Post Any Injection 0 0
Crying Post Injection 1 81 68
Crying Post Injection 2 57 52
Crying Post Injection 3 43 47
Grade 3 Crying Post Any Injection 1 1
Somnolence Post Injection 1 55 65
Somnolence Post Injection 2 41 37
Somnolence Post Injection 3 23 28
Grade 3 Somnolence Post Any Injection 2 2
Any Anorexia Post Injection 1 35 42
Anorexia Post Injection 2 24 22
Anorexia Post Injection 3 24 25
Grade 3 Anorexia Post Any Injection 0 1
Irritability Post Injection 1 85 81
Irritability Post Injection 2 63 65
Irritability Post Injection 3 40 55
Grade 3 Irritability Post Any Injection 2 1
Time Frame Adverse events data were collected from Day 0 after the first injection to up to 30 days after each injection.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Hide Arm/Group Description All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
All-Cause Mortality
DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/132 (2.27%)      2/131 (1.53%)    
Hepatobiliary disorders     
Hepatic Cyst * 1  0/132 (0.00%)  0 1/131 (0.76%)  1
Infections and infestations     
Cellulitis * 1  1/132 (0.76%)  1 0/131 (0.00%)  0
Pneumonia Viral * 1  1/132 (0.76%)  1 0/131 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchial Obstruction * 1  1/132 (0.76%)  1 1/131 (0.76%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
DTaP-IPV-Hep B-PRP~T Group Infanrix Hexa™ Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   102/132 (77.27%)      106/131 (80.92%)    
Gastrointestinal disorders     
Abdominal Pain * 1  38/132 (28.79%)  61 44/131 (33.59%)  65
Diarrhea * 1  17/132 (12.88%)  19 18/131 (13.74%)  21
Vomiting  1  29/132 (21.97%)  29 32/131 (24.43%)  32
General disorders     
Injection Site Hemorrhage * 1  8/132 (6.06%)  9 4/131 (3.05%)  4
Injection Site Pain  1  102/132 (77.27%)  102 101/131 (77.10%)  101
Injection Site Erythema  1  78/132 (59.09%)  78 66/131 (50.38%)  66
Injection Site Swelling  1  54/132 (40.91%)  54 52/131 (39.69%)  52
Irritability  1  100/132 (75.76%)  100 98/131 (74.81%)  98
Pyrexia  1  37/132 (28.03%)  37 36/131 (27.48%)  36
Pyrexia * 1  11/132 (8.33%)  13 7/131 (5.34%)  7
Infections and infestations     
Nasopharyngitis * 1  62/132 (46.97%)  78 80/131 (61.07%)  118
Pharyngitis * 1  11/132 (8.33%)  11 15/131 (11.45%)  15
Anorexia  1  54/132 (40.91%)  54 58/131 (44.27%)  58
Nervous system disorders     
Somnolence  1  73/132 (55.30%)  73 82/131 (62.60%)  82
Psychiatric disorders     
Crying  1  100/132 (75.76%)  100 93/131 (70.99%)  93
Respiratory, thoracic and mediastinal disorders     
Bronchospasm * 1  13/132 (9.85%)  14 12/131 (9.16%)  14
Cough * 1  14/132 (10.61%)  16 18/131 (13.74%)  24
Skin and subcutaneous tissue disorders     
Dermatitis * 1  9/132 (6.82%)  9 6/131 (4.58%)  6
Dermatitis Diaper * 1  14/132 (10.61%)  15 10/131 (7.63%)  10
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00831753     History of Changes
Other Study ID Numbers: A3L17
First Submitted: January 27, 2009
First Posted: January 29, 2009
Results First Submitted: February 14, 2014
Results First Posted: April 2, 2014
Last Update Posted: May 13, 2016