Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

NCT00258908 | Completed Phase 3 Results

• 1 other identifier: TD521
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration. To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.

Conditions

Diphtheria; Tetanus; Pertussis

Keywords

ADACEL™; Tetanus; Diphteria; Acellular pertussis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination

  Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.

  Day 0 and Day 28 Post-vaccination

• Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination

  GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.

  Day 0 and Day 28 post-vaccination

Secondary Outcomes (1)

• Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination

  Within 8 days of vaccination

Interventions

Diphteria, tetanus, and Acellular Pertussis vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: ADACEL™

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent form (ICF) signed by parent(s)/legal representative
• Able to attend all scheduled visits and to comply with all trial procedures
• Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP)

You may not qualify if:

• Participation in another clinical trial in the 4 weeks preceding the trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long term systemic corticosteroids therapy
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, one of the following adverse events
• encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose
• temperature of \> 40.5 °C within 48 hours not due to another identifiable cause
• collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
• persistent, inconsolable crying lasting \> 3 hours, occurring within 48 hours
• seizure with or without fever occurring within 3 days
• Chronic illness at a stage that could interfere with trial conduct or completion.
• Blood or blood-derived products received in the past 3 months
• Any vaccination in the 4 weeks preceding the trial vaccination (except Oral Poliomyelitis Vaccine \[OPV\])
• Any vaccination planned during the present trial period (except OPV)
• History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically)
• Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Unknown Facility

Taipei, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diphtheria; Tetanus; Whooping Cough

Interventions

Tetanus Toxoid; adacel

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2005
• First Posted: November 28, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: April 14, 2016
• Results First Posted: June 8, 2009

Record last verified: 2016-04

Locations

TW (1)