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Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™

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ClinicalTrials.gov Identifier: NCT00802867
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : January 12, 2010
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: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Diphtheria
Tetanus
Pertussis
Polio
Haemophilus Infection
Intervention Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
Enrollment 989
Recruitment Details Participants were enrolled from 05 February through 30 November 2004 at 19 US sites.
Pre-assignment Details A total of 989 participants were enrolled and vaccinated with DAPTACEL as the fifth dose after receiving 4 doses of Pentacel vaccine in previous studies.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Period Title: Overall Study
Started 989
Completed 976
Not Completed 13
Reason Not Completed
Lost to Follow-up             6
Protocol Violation             6
Withdrawal by Subject             1
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Baseline Participants 989
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 989 participants
<=18 years
989
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 989 participants
4.2  (0.15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 989 participants
Female
514
  52.0%
Male
475
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 989 participants
989
1.Primary Outcome
Title Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel®
Hide Description

Solicited local reactions: Redness, swelling, tenderness at injection site, change in limb circumference, and limb function.

Systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.
Time Frame 0 to 3 days post-dose 5 vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants intend-to-treat population.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description:
Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Participants Analyzed 982
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Systemic Reaction Post-dose 5 62
Any Redness (> 5 mm) 20
Grade 3 Redness (> 50 mm) 7
Any Swelling (> 5 mm) 12
Grade 3 Swelling (> 50 mm) 3
Any Tenderness 50
Grade 3 Tenderness (Incapacitating) 0
Any Change in Limb Circumference (> 5 mm) 29
Grade 3 Change in Limb Circumference (> 40 mm) 1
Any Functional Impairment 9
Grade 3 Functional Impairment (Incapacitating) 0
Any Solicited Systemic Reaction Post-dose 5 37
Any Fever (≥ 38 ºC) 5
Grade 3 Fever (> 39.5 ºC) 0
Any Irritability 23
Grade 3 Irritability (Incapacitating) 1
Any Crying 7
Grade 3 Crying (Incapacitating) 0
Any Lethargy 13
Grade 3 Lethargy (Incapacitating) 0
Any Anorexia 11
Grade 3 Anorexia (Skips 2 meals) 1
Any Vomiting 3
Grade 3 Vomiting (≥ 3 episodes) 1
Any Diarrhea 4
Grade 3 Diarrhea (> 5 diarrhea stools) 0
Rash Present 5
2.Other Pre-specified Outcome
Title Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose.
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 vaccine antibody responses were evaluated in a subset of the per-protocol population for immunogenicity.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description:
Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Pertussis (EU/mL) ≥ 4-Fold Rise 94
Anti-Filamentous Haemagglutinin ≥ 4-Fold Rise 91
Anti-Fimbriae Types 2 and 3 ≥ 4-Fold Rise 91
Anti-Pertactin (EU/mL) ≥ 4-Fold Rise 90
3.Other Pre-specified Outcome
Title Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose
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 evaluated in a subset of the per-protocol population for immunogenicity.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description:
Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-Pertussis (EU/mL) 98
Anti-Filamentous Haemagglutinin 97
Anti-Fimbriae Types 2 and 3 96
Anti-Pertactin (EU/mL) 95
4.Other Pre-specified Outcome
Title Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Hide Description Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination
Time Frame Day 28 to 48 Post-dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
The anti-Diphtheria and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description:
Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Participants Analyzed 228
Measure Type: Number
Unit of Measure: Percentage of Participants
Anti-Diphtheria (IU/mL) ≥0.01 Pre-dose 5 100
Anti-Diphtheria (IU/mL) ≥0.1 Pre-dose 5 77
Anti-Diphtheria (IU/mL) ≥1.0 Pre-dose 5 9
Anti-Diphtheria (IU/mL) ≥0.1 Post-dose 5 100
Anti-Diphtheria (IU/mL) ≥1.0 Post-dose 5 100
Anti-Tetanus (IU/mL) ≥0.01 Pre-dose 5 100
Anti-Tetanus (IU/mL) ≥0.1 Pre-dose 5 92
Anti-Tetanus (IU/mL) ≥1.0 Pre-dose 5 13
Anti-Tetanus (IU/mL) ≥0.1 Post-dose 5 100
Anti-Tetanus (IU/mL) ≥1.0 Post-dose 5 96
5.Other Pre-specified Outcome
Title Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose
Hide Description [Not Specified]
Time Frame Pre-dose 5 and Day 28 to 48 Post-dose 5
Hide Outcome Measure Data
Hide Analysis Population Description
The GMTs of anti-Pertussis, anti-Diphtheria, and anti-Tetanus Toxoids Responses were evaluated in a subset of the per-protocol population for immunogenicity.
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description:
Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
Overall Number of Participants Analyzed 228
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Pertussis (EU/mL) - Pre-dose 5
12.73
(10.85 to 14.94)
Anti-Pertussis (EU/mL) - Post-dose 5
309.64
(276.16 to 347.18)
Anti-Filamentous Haemagglutinin (EU/mL) Pre-dose 5
9.90
(8.49 to 11.55)
Anti-Filamentous Haemagglutinin (EU/mL) Post-dose5
158.27
(144.26 to 173.63)
Anti-Fimbriae Types 2 and 3 (EU/mL) Pre-dose 5
40.62
(35.13 to 46.98)
Anti-Fimbriae Types 2 and 3 (EU/mL) Post-dose 5
659.28
(595.32 to 730.12)
Anti-Pertactin (EU/mL) Pre-dose 5
10.36
(8.92 to 12.02)
Anti-Pertactin (EU/mL) Post-dose 5
140.86
(122.24 to 162.31)
Anti-Diphtheria (IU/mL) Pre-dose 5
0.25
(0.22 to 0.28)
Anti-Diphtheria (IU/mL) Post-dose 5
18.98
(17.10 to 21.07)
Anti-Tetanus (IU/mL) Pre-dose 5
0.38
(0.33 to 0.42)
Anti-Tetanus (IU/mL) Post-dose 5
4.30
(3.86 to 4.79)
Time Frame Adverse event data were collected for 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DAPTACEL® Vaccine Group
Hide Arm/Group Description Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
All-Cause Mortality
DAPTACEL® Vaccine Group
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
DAPTACEL® Vaccine Group
Affected / at Risk (%) # Events
Total   10/989 (1.01%)    
Blood and lymphatic system disorders   
Idiopathic thrombocytopenic purpura * 1  1/989 (0.10%)  1
Infections and infestations   
Appendicitis * 1  1/989 (0.10%)  1
Cellulitis * 1  1/989 (0.10%)  1
Gastroenteritis nos * 1  1/989 (0.10%)  1
Pneumonia nos * 1  1/989 (0.10%)  1
Metabolism and nutrition disorders   
Dehydration * 1  2/989 (0.20%)  2
Nervous system disorders   
Febrile convulsion * 1  1/989 (0.10%)  1
Obstructive sleep apnoea syndrome * 1  1/989 (0.10%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma nos * 1  2/989 (0.20%)  2
Tonsillar hypertrophy * 1  1/989 (0.10%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAPTACEL® Vaccine Group
Affected / at Risk (%) # Events
Total   49/989 (4.95%)    
Infections and infestations   
Upper respiratory tract infection NOS * 1  49/989 (4.95%)  49
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
[Not Specified]
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: NCT00802867    
Other Study ID Numbers: P3T10
First Submitted: December 4, 2008
First Posted: December 5, 2008
Results First Submitted: September 24, 2009
Results First Posted: January 12, 2010
Last Update Posted: April 14, 2016