Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00802867|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : January 12, 2010
Last Update Posted : April 14, 2016
- To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- To present immunogenicity before and after a single dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis Polio Haemophilus Infection||Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||989 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Immunogenicity of DAPTACEL® (CP10/5/5/3DT Aventis Pasteur 5-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™ (HCP20/20/5/3DT-mIPV//PRP-T)|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||September 2005|
Subjects in Study 494-01 and Study 494-03 who had received 4 doses of Pentacel™ vaccine.
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
0.5 mL, Intramuscular
Other Name: DAPTACEL®
- Percentage of Participants With Solicited Local or Systemic Reactions Post-vaccination With DAPTACEL® as the Fifth Dose After 4 Doses of Pentacel® [ Time Frame: 0 to 3 days post-dose 5 vaccination ]
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.
- Percentage of Participants With 4-Fold Rises in Anti-Pertussis Post-vaccination With DAPTACEL® as a Fifth Dose. [ Time Frame: Day 28 to 48 Post-dose 5 ]
Anti-pertussis (anti-Pertussis, anti-Filamentous Haemagglutinin, anti-Fimbriae, and anti-Pertactin).
Fold-rise is calculated as Post-Dose 5/Pre-Dose 5 titer.
- Percentage of Participants With Anti-Pertussis Booster Response Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Day 28 to 48 Post-dose 5 ]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.
- Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Seroprotection Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Day 28 to 48 Post-dose 5 ]Seroprotection is defined as a titer of ≥ 0.01 IU/mL for both Diphtheria and Tetanus before the fifth dose booster vaccination
- Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-vaccination With DAPTACEL® as a Fifth Dose [ Time Frame: Pre-dose 5 and Day 28 to 48 Post-dose 5 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00802867
|United States, Arkansas|
|Jonesboro, Arkansas, United States, 72401|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|Oakland, California, United States, 94612|
|Torrance, California, United States, 90502|
|United States, Florida|
|Orlando, Florida, United States, 32806|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Woburn, Massachusetts, United States, 01801|
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|United States, New York|
|Albany, New York, United States, 12208|
|Rochester, New York, United States, 14620|
|United States, North Carolina|
|Chapel Hill, North Carolina, United States, 27514|
|Sylva, North Carolina, United States, 28779|
|United States, Pennsylvania|
|Pittsburgh, Pennsylvania, United States, 15241|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|San Antonio, Texas, United States, 78205|
|United States, Utah|
|Layton, Utah, United States, 84041|
|United States, Washington|
|Vancouver, Washington, United States, 98664|
|United States, Wisconsin|
|Marshfield, Wisconsin, United States, 54449|
|Study Director:||Medical Monitor||Sanofi Pasteur Inc.|