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Trial record 1 of 1 for:    P3T11
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Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

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ClinicalTrials.gov Identifier: NCT00258895
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : September 28, 2009
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Intervention Biological: DAPTACEL®: DTaP
Enrollment 649
Recruitment Details Participants were enrolled from 30 March 2005 to 02 March 2006 at 22 US sites.
Pre-assignment Details A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Period Title: Overall Study
Started 487 162
Completed 477 159
Not Completed 10 3
Reason Not Completed
Lost to Follow-up             3             1
Protocol Violation             6             2
Withdrawal by Subject             1             0
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed Total
Hide Arm/Group Description Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study. Total of all reporting groups
Overall Number of Baseline Participants 487 162 649
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 487 participants 162 participants 649 participants
<=18 years
487
 100.0%
162
 100.0%
649
 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:  Years
Number Analyzed 487 participants 162 participants 649 participants
4.1  (0.14) 4.1  (0.16) 4.1  (0.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 487 participants 162 participants 649 participants
Female
244
  50.1%
83
  51.2%
327
  50.4%
Male
243
  49.9%
79
  48.8%
322
  49.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 487 participants 162 participants 649 participants
487 162 649
1.Primary Outcome
Title Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination
Hide Description [Not Specified]
Time Frame 0 to 7 days Post-Dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description:
Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Number of Participants Analyzed 485 162
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Local Reaction - Dose 5 75 70
Any Redness (> 5 mm) 36 24
Grade 3 Redness (> 50 mm) 16 9
Any Swelling (> 5 mm) 24 14
Grade 3 Swelling (> 50 mm) 8 1
Any Tenderness 62 55
Grade 3 Tenderness (Incapacitating) 2 0
Any Change in Limb Circumference (> 5 mm) 39 32
Grade 3 Change in Limb Circumference (> 40 mm) 2 0
Any Functional Impairment 20 12
Grade 3 Functional Impairment (Incapacitating) 0 0
Any Solicited Systemic Reaction - Dose 5 55 45
Any Fever (≥ 38.0 ºC) 8 6
Grade 3 Fever (> 39.5 ºC) 0 1
Any Irritability 36 28
Grade 3 Irritability (Incapacitating) 0 0
Any Crying 15 11
Grade 3 Crying (Incapacitating) 0 0
Any Lethargy 22 17
Grade 3 Lethargy (Incapacitating) 1 1
Any Anorexia 16 14
Grade 3 Anorexia (skipped 2 meals) 1 1
Any Vomiting (per 24 hours) 4 4
Grade 3 Vomiting (≥ 3 episodes) 1 0
Any Diarrhea (per 24 hours) 8 6
Grade 3 Diarrhea (> 5 diarrhea stools) 0 0
Any Rash 10 5
2.Primary Outcome
Title Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination
Hide Description Anti-Pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin) Fold-rise is calculated as post-Dose 5/pre-Dose 5 titer.
Time Frame Day 28 to 48 Post-dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-Pertussis 4-fold rises were evaluated in the per-protocol immunology population.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description:
Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Number of Participants Analyzed 251 80
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Pertussis (EU/mL) 92 98
Anti-Filamentous Haemagglutinin (EU/mL) 89 89
Anti-Fimbriae Types 2 and 3 (EU/mL) 90 96
Anti-Pertactin (EU/mL) 94 95
3.Primary Outcome
Title Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination
Hide Description Booster response calculation: If pre-Dose 5 titer < 4x limit of quantitation (LOQ) a 4-fold rise of post-Dose 5/pre-Dose 5. If pre-Dose 5 titer ≥ 4x LOQ a 2-fold rise of post-Dose 5/pre-Dose 5.
Time Frame Day 28 to 48 Post-Dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-pertussis booster response was assessed in the per-protocol immunogenicity population.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description:
Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Number of Participants Analyzed 251 80
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Pertussis (EU/mL) 96 99
Anti-Fillamentous Haemagglutinin (EU/mL) 93 96
Anti-Fimbriae Types 2 and 3 (EU/mL) 96 99
Anti-Pertactin (EU/mL) 97 96
4.Primary Outcome
Title Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination.
Hide Description [Not Specified]
Time Frame Day 0 and between Days 28-48 Post-dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
Antibody responses were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description:
Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Number of Participants Analyzed 251 81
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Diphtheria (IU/mL) ≥ 0.01 Pre-dose 5 99 99
Anti-Diphtheria (IU/mL) ≥ 0.1 Pre-dose 5 47 50
Anti-Diptheria (IU/mL) ≥ 1.0 Pre-dose 5 1 1
Anti-Diphtheria (IU/mL) ≥ 0.1 Post-dose 5 100 100
Anti-Diphtheria (IU/mL) ≥ 1.0 Post-dose 5 100 100
Anti-Tetanus (IU/mL) ≥ 0.01 Pre-dose 5 100 99
Anti-Tetanus (IU/mL) ≥ 0.1 Pre-dose 5 85 82
Anti-Tetanus (IU/mL) ≥ 1.0 Pre-dose 5 20 12
Anti-Tetanus (IU/mL) ≥ 0.1 Post-dose 5 100 100
Anti-Tetanus (IU/mL) ≥ 1.0 Post-dose 5 99 98
5.Primary Outcome
Title Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination
Hide Description [Not Specified]
Time Frame Day 0 and between Days 28-48 post-dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
GMTs were assessed for each of the antigens in DAPTACEL vaccine in the per-protocol immunogenicity population.
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description:
Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
Overall Number of Participants Analyzed 255 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: All units
Anti-Pertussis (EU/mL) Pre-Dose
7.67
(6.66 to 8.84)
9.80
(7.81 to 12.29)
Anti-Pertussis (EU/mL) Post-Dose
154.32
(139.58 to 170.62)
180.77
(150.33 to 217.38)
Anti-Filamentous Haemagglutinin (EU/mL) Pre-Dose
5.03
(4.25 to 5.96)
7.52
(5.45 to 10.39)
Anti-Filamentous Haemagglutinin (EU/mL) Post-Dose
82.11
(73.39 to 91.88)
120.03
(98.10 to 146.86)
Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose
24.45
(21.22 to 28.16)
34.50
(27.00 to 44.09)
Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose
450.56
(407.40 to 498.30)
649.86
(551.73 to 765.45)
Anti-Pertactin (EU/mL) Pre-dose
15.62
(13.72 to 17.78)
9.16
(7.10 to 11.81)
Anti-Pertactin (EU/mL) Post-dose
229.59
(207.45 to 254.08)
148.80
(120.63 to 183.55)
Anti-Diphtheria (IU/mL) Pre-dose
0.11
(0.09 to 0.12)
0.11
(0.08 to 0.14)
Anti-Diphtheria (IU/mL) Post-dose
19.59
(17.06 to 22.51)
22.56
(17.78 to 28.62)
Anti-Tetanus (IU/mL) Pre-dose
0.38
(0.33 to 0.43)
0.27
(0.21 to 0.34)
Anti-Tetanus (IU/mL) Post-dose
6.21
(5.59 to 6.89)
4.47
(3.75 to 5.34)
Time Frame Adverse events data were collected from the day of vaccination for 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DAPTACEL®-Primed Pentacel®-Primed
Hide Arm/Group Description Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study. Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
All-Cause Mortality
DAPTACEL®-Primed Pentacel®-Primed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DAPTACEL®-Primed Pentacel®-Primed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/487 (1.03%)      3/162 (1.85%)    
Blood and lymphatic system disorders     
Thrombocytopenic purpura * 1  0/487 (0.00%)  0 1/162 (0.62%)  1
Cardiac disorders     
Supraventricular tachycardia * 1  0/487 (0.00%)  0 1/162 (0.62%)  1
Infections and infestations     
Gastroenteritis NOS * 1  0/487 (0.00%)  0 2/162 (1.23%)  2
Otitis media NOS * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Pneumonia respiratory syncytial viral * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Injury, poisoning and procedural complications     
Head injury * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Skull fracture NOS * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  0/487 (0.00%)  0 1/162 (0.62%)  1
Psychiatric disorders     
Staring * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Bronchospasm NOS * 1  1/487 (0.21%)  1 0/162 (0.00%)  0
Skin and subcutaneous tissue disorders     
Asthma NOS * 1  2/487 (0.41%)  2 0/162 (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 5.0%
DAPTACEL®-Primed Pentacel®-Primed
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   62/487 (12.73%)      55/162 (33.95%)    
Gastrointestinal disorders     
Lethargy  1  22/487 (4.52%)  17/162 (10.49%) 
General disorders     
Injection site redness  1  36/487 (7.39%)  24/162 (14.81%) 
Injection site swelling  1  24/487 (4.93%)  14/162 (8.64%) 
Injection site tenderness  1  62/487 (12.73%)  55/162 (33.95%) 
Infections and infestations     
Otitis media NOS * 1  24/487 (4.93%)  9/162 (5.56%) 
Upper respiratory tract infection NOS * 1  34/487 (6.98%)  7/162 (4.32%) 
Musculoskeletal and connective tissue disorders     
Anorexia  1  16/487 (3.29%)  14/162 (8.64%) 
Psychiatric disorders     
Irritability  1  36/487 (7.39%)  28/162 (17.28%) 
Crying  1  15/487 (3.08%)  11/162 (6.79%) 
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: NCT00258895     History of Changes
Other Study ID Numbers: P3T11
First Submitted: November 24, 2005
First Posted: November 28, 2005
Results First Submitted: August 18, 2009
Results First Posted: September 28, 2009
Last Update Posted: April 14, 2016