Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00258908
First received: November 24, 2005
Last updated: November 18, 2009
Last verified: November 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis |
Biological: Diphteria, tetanus, and Acellular Pertussis vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Reponses Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 Post-vaccination ] [ Designated as safety issue: No ]
- Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 post-vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination [ Time Frame: Within 8 days of vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 115 |
| Study Start Date: | November 2005 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
0.5 mL, Intramuscular
Other Name: ADACEL™
Eligibility| Ages Eligible for Study: | 6 Years to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
- 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
- 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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Sanofi Pasteur, Inc. |
| ClinicalTrials.gov Identifier: | NCT00258908 History of Changes |
| Other Study ID Numbers: | TD521 |
| Study First Received: | November 24, 2005 |
| Results First Received: | April 7, 2009 |
| Last Updated: | November 18, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Sanofi:
|
ADACEL™ Tetanus Diphteria Acellular pertussis |
Additional relevant MeSH terms:
|
Diphtheria Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bordetella Infections Gram-Negative Bacterial Infections Respiratory Tract Infections |
Infection Respiratory Tract Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Hypocalcemia Calcium Metabolism Disorders Metabolic Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013