Study of Adacel® Vaccine Administered to Persons 10 Years of Age.
- Conditions
- Active immunization against tetanus, diphtheria and pertussisMedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005627-84-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1300
1) Age is > 10 to < 12 years of age at the time of vaccination.
2) Assent form has been signed and dated by the subject, and informed consent has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations).
3) Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
4) For a female of childbearing potential, abstinence or use of an effective method of contraception from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.
5) Documented vaccination history of receiving 5 previous doses of DTaP vaccine (consisting of 3 infant doses in the first year of life, a 4th dose in the 2nd year of life, and a 5th dose at 4 through 6 years of age).
Are the trial subjects under 18? yes
Number of subjects for this age range: 1300
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1) Any condition which, in the opinion of the Investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.
2) Serious, acute, or chronic disease that is unstable or that, in the opinion of the Investigator, might:
• interfere with the ability to participate fully in the study; or
• interfere with evaluation of the vaccine.
3) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
4) Prior receipt of pertussis, diphtheria, or tetanus containing vaccines within the past 5 years.
5) A personal history of physician-diagnosed or laboratory confirmed pertussis disease within the last 2 years.
6) A previous severe reaction to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days or seizure within 3 days of receiving the vaccine.
7) Receipt of blood or blood-derived products in the past 3 months, which might interfere with the assessment of the immune response.
8) Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances.
9) Receipt of any vaccine within 30 days of receiving study vaccine, or plans to receive another vaccine before the 2nd visit; except that influenza vaccine may have been received between 30 and 15 days (but no fewer than 15 days) before receiving study vaccine.
10) Participation in another interventional clinical trial in the 30 days preceding enrollment or planning to participate in another interventional clinical trial during the planned period of this study (between Visit 1 and Visit 2).
11) Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as reported by the parent/guardian.
12) Thrombocytopenia, bleeding disorders, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination.
13) Known pregnancy, or a positive urine or serum pregnancy test.
14) Prior personal history of Guillain-Barré syndrome.
15) Identified as employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Temporary Contraindications:
A prospective subject must not be included in the study until the following condition(s) and/or symptoms are resolved:
• Febrile illness (temperature =100.4°F) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method