Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258908
• Other study ID #: TD521
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2005
• Last updated: April 12, 2016
• Start date: November 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• Aged from 6 to 8 years on the day of inclusion

• 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)

• Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire

Exclusion Criteria:

• 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

1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose

2. temperature of > 40.5 °C within 48 hours not due to another identifiable cause

3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours

4. persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours

5. 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

• Clinical or serological evidence of systemic illness including Hepatitis B, C or Human Immunodeficiency Virus (HIV)

• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination

• History of/current seizures

• Febrile illness (axillary temperature = 37.4 °C) or acute illness on the day of inclusion

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus

Intervention

Biological:
• Diphteria, tetanus, and Acellular Pertussis vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination	The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose	Within 8 days of vaccination	Yes

External Links

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