Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
- 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.
|Diphtheria Tetanus Pertussis Polio Haemophilus Infection||Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)||Phase 4|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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)|
- 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 ]
|Study Start Date:||February 2004|
|Study Completion Date:||September 2005|
|Primary Completion Date:||June 2005 (Final data collection date for primary outcome measure)|
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®
Please refer to this study by its ClinicalTrials.gov identifier: 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.|