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Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

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ClinicalTrials.gov Identifier: NCT00315055
Recruitment Status : Completed
First Posted : April 17, 2006
Results First Posted : February 4, 2014
Last Update Posted : September 12, 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 Hepatitis B
Polio
Diphtheria
Pertussis
Interventions Biological: DTaP-IPV-HB-PRP~T vaccine
Biological: DTaP-IPV//PRP~T combined
Biological: Hepatitis B vaccine
Enrollment 310
Recruitment Details Participants were enrolled and treated from 01 June 2006 to 18 June 2007 in 1 clinical center in Turkey.
Pre-assignment Details A total of 310 participants who met the inclusion but non of the exclusion criteria were enrolled and vaccinated.
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Period Title: Overall Study
Started 155 155
Completed 152 150
Not Completed 3 5
Reason Not Completed
Protocol Violation             2             4
Lost to Follow-up             1             1
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX® Total
Hide Arm/Group Description Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). Total of all reporting groups
Overall Number of Baseline Participants 155 155 310
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 310 participants
<=18 years
155
 100.0%
155
 100.0%
310
 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 155 participants 155 participants 310 participants
2.08  (0.090) 2.08  (0.102) 2.08  (0.096)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants 155 participants 310 participants
Female
67
  43.2%
72
  46.5%
139
  44.8%
Male
88
  56.8%
83
  53.5%
171
  55.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Turkey Number Analyzed 155 participants 155 participants 310 participants
155 155 310
1.Primary Outcome
Title Percentage of Participants With Anti HBs Seroprotection After the 3 Dose Primary Vaccination Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B® Vaccines
Hide Description Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Time Frame Day 90 post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Seroprotection against HBs was assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX® PEDIATRIC
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 134 128
Measure Type: Number
Unit of Measure: Percentage of Participants
94 96
2.Secondary Outcome
Title Percentage of Participants With Seroprotection Against Hepatitis B Surface Antigen, Polyribosyl Ribitol Phosphate, Diptheria, and Tetanus After the 3 Dose Primary Series With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ + ENGERIX B®
Hide Description Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to Polyribosyl ribitol phosphate and tetanus were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet. Seroprotection was defined as: titers ≥ 100 mIU/mL for HBs; ≥ 0.01 and ≥ 0.1 IU/mL for anti-Tetanus and anti-diphtheria, and ≥ 0.15 µg/mL and ≥ 1.0 µg/mL for anti-PRP.
Time Frame Day 90 post first dose
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 the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 145 141
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-HBs (≥ 100 mIU/mL; N = 134, 128) 65 78
Anti-PRP (≥ 0.15 µg/mL; N = 140, 138) 91 98
Anti-PRP (≥ 1.0 µg/mL; N = 140, 138) 73 77
Anti-Diphtheria (≥0.01 IU/mL; N = 144, 138) 99 97
Anti-Diphtheria (≥0.1 IU/mL; N=144, 138) 34 44
Anti-Tetanus (≥0.01 IU/mL; N = 145, 139) 100 100
Anti-Tetanus (≥0.1 IU/mL; N = 145, 139) 100 99
3.Secondary Outcome
Title Percentage of Participants With Seroprotection Against Poliovirus Antigens After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Hide Description Antibodies to poliovirus types 1, 2, and 3 were measured by microneutralization on Vero cell culture. Seroprotection was defined as titers ≥8 1/dil.
Time Frame Day 90 post first dose
Hide Outcome Measure Data
Hide Analysis Population Description
Anti poliovirus antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 145 141
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Polio 1 (N = 87, 94) 98 98
Anti-Polio 2 (N = 75, 83) 95 94
Anti-Polio 3 (N = 76, 78) 97 100
4.Secondary Outcome
Title Percentage of Participants With Anti-Pertussis Seroconversion After the 3 Dose Primary Series Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Hide Description Antibodies to pertussis toxoid (PT) and filamentous hemagglutinin (FHA) were measured by means of enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4-fold increase in titer between baseline (Day 0 pre-vaccination and Day 30 post-dose 3 (Day 90).
Time Frame Day 0 (pre-vaccination) and Day 30 post-dose 3
Hide Outcome Measure Data
Hide Analysis Population Description
Anti-pertussis antibodies were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Arm/Group Title DTaP-IPV-HB-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 145 141
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-PT (Pre-dose 1; N = 143, 140) 55 48
Anti-PT (Post-dose 3; N = 143, 140) 100 100
Anti-FHA (Pre-dose 1; N = 145, 140) 65 62
Anti-FHA (Post-dose 3; N = 144, 137) 100 100
5.Secondary Outcome
Title Geometric Mean Titers of Antibodies After the 3 Dose Primary Series With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Hide Description Antibodies to hepatitis B surface antigen (HBs) were measured by means of automated enhanced chemoluminescence assay. Antibodies to PRP, tetanus, pertussis toxoid (PT), and filamentous hemagglutinin (FHA) were measured by enzyme linked immunosorbent assay (ELISA), and antibodies to diphtheria were measured by a neutralization test using crystal violet.
Time Frame Day 90 (30 Days post-dose 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed in all participants who did not have any protocol violation that might have interfered with the primary criteria evaluation (Per-Protocol Population). Totals are number of participants with available data for the endpoint.
Arm/Group Title DTaP-IPV-HB-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 145 141
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-HBs (N = 134, 128)
149
(115 to 191)
265
(205 to 342)
Anti-PRP (N = 140, 138)
2.12
(1.62 to 2.77)
2.37
(1.91 to 2.94)
Anti-Diphtheria (N = 144, 138)
0.071
(0.060 to 0.084)
0.091
(0.075 to 0.110)
Anti-Tetanus (N = 145, 139)
0.839
(0.731 to 0.962)
0.709
(0.625 to 0.804)
Anti-Polio 1 (N = 87, 94)
102
(74.9 to 138)
112
(85.4 to 147)
Anti-Polio 2 (N = 75, 83)
73.5
(52.9 to 102)
78.2
(58.2 to 105)
Anti-Polio 3 (N = 76, 78)
133
(93.0 to 190)
214
(159 to 288)
Anti-PT (N = 143, 140)
123
(109 to 139)
138
(122 to 155)
Anti-FHA (N = 144, 137)
102
(90.4 to 114)
69.3
(62.0 to 77.6)
6.Secondary Outcome
Title Number of Participants With at Least a Solicited Injection Site or Systemic Reaction After Vaccination With Either DTaP-IPV-HB-PRP~T or PENTAXIM™ + ENGERIX B®
Hide Description Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability
Time Frame Day 0 to Day 7 post any dose
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited reactions were assessed in all participants who received at least 1 injection of study vaccine (Safety Analysis Set) according to the vaccine actually received.
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description:
Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
Overall Number of Participants Analyzed 153 152
Measure Type: Number
Unit of Measure: Participants
Injection site Pain Post-dose 1 (N = 153, 152) 70 55
Injection site Pain Post-dose 2 (N = 152, 150) 66 58
Injection site Pain Post-dose 3 (N = 152, 150) 57 48
Injection site Erythema Post-dose 1 (N = 153, 152) 23 17
Injection site Erythema Post-dose 2 (N = 152, 150) 25 17
Injection site Erythema Post-dose 3 (N = 152, 150) 30 17
Injection site Swelling Post-dose 1 (N = 153, 152) 21 16
Injection site Swelling Post Dose 2 (N=152, 150) 21 12
Injection site Sweling Post Dose 3 (N = 152, 150) 17 11
Pyrexia Post-dose 1 (N = 153, 152) 15 12
Pyrexia Post-dose 2 (N = 152, 150) 33 23
Pyrexia Post-dose 3 (N = 152, 150) 41 24
Vomiting Post-dose 1 (N = 153, 152) 57 44
Vomiting Post-dose 2 (N = 152, 150) 55 48
Vomiting Post-dose 3 (N = 152, 150) 44 40
Crying Post-dose 1 (N = 153, 152) 51 41
Crying Post-dose 2 (N = 152, 150) 54 38
Crying Post-dose 3 (N = 152, 150) 45 30
Somnolence Post-dose 1 (N = 153, 152) 51 45
Somnolence Post-dose 2 (N = 152, 150) 35 38
Somnolence Post-dose 3 (N = 152, 150) 26 36
Anorexia Post-dose 1 (N = 153, 152) 43 27
Anorexia Post-dose 2 (N = 152, 150) 48 35
Anorexia Post-dose 3 (N = 152, 150) 42 40
Irritability Post-dose 1 (N = 153, 152) 83 67
Irritability Post-dose 2 (N = 152, 150) 81 74
Irritability Post-dose 3 (N = 152, 150) 71 64
Time Frame Adverse events were assessed following the administration first dose of study vaccine (Day 0) through 6 months after the last dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Hide Arm/Group Description Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60). Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
All-Cause Mortality
DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/153 (1.31%)      3/152 (1.97%)    
Infections and infestations     
Bronchiolitis * 1  0/153 (0.00%)  0 1/152 (0.66%)  1
Bronchopneumonia * 1  1/153 (0.65%)  1 1/152 (0.66%)  1
Upper Respiratory Tract Infection * 1  1/153 (0.65%)  1 0/152 (0.00%)  0
Injury, poisoning and procedural complications     
Road Traffic Accident * 1  0/153 (0.00%)  0 1/152 (0.66%)  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%
DTaP-IPV-Hep B-PRP~T PENTAXIM™ and ENGERIX®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   83/153 (54.25%)      74/152 (48.68%)    
Gastrointestinal disorders     
Vomiting  1  57/153 (37.25%)  57 48/152 (31.58%)  48
General disorders     
Injection Site Pain  1  70/153 (45.75%)  70 58/152 (38.16%)  58
Injection Site Erythema  1  30/153 (19.61%)  30 17/152 (11.18%)  17
Injection Site Swelling  1  21/153 (13.73%)  21 16/152 (10.53%)  16
Irritability  1  83/153 (54.25%)  83 74/152 (48.68%)  74
Pyrexia  1  41/152 (26.97%)  41 24/152 (15.79%)  24
Metabolism and nutrition disorders     
Anorexia  1  48/153 (31.37%)  48 40/152 (26.32%)  40
Nervous system disorders     
Somnolence  1  51/153 (33.33%)  51 45/152 (29.61%)  45
Psychiatric disorders     
Crying  1  54/153 (35.29%)  54 41/152 (26.97%)  41
Indicates events were collected by 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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00315055     History of Changes
Other Study ID Numbers: A3L10
First Submitted: April 13, 2006
First Posted: April 17, 2006
Results First Submitted: September 9, 2013
Results First Posted: February 4, 2014
Last Update Posted: September 12, 2014