Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diphtheria Tetanus Pertussis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Diphteria, tetanus, and Acellular Pertussis vaccine

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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ADACEL™

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes