Study of Tdap Combined Vaccine (ADACEL) as a Booster Dose in Healthy Adults and Children in China.
- 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
- EUCTR2015-003914-25-Outside-EU/EEA
- Lead Sponsor
- SANOFI PASTEUR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 40
An individual had to fulfill all of the following criteria in order to be eligible for trial
enrollment:
1) Group 1: Aged 18 through 64 years on the day of inclusion
Group 2: Aged 4 through 8 years on the day of inclusion
2) Informed consent form (ICF) signed by the subject (Group 1) or by the parent(s) or legal representative (Group 2)
3) Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend all scheduled visits and to comply with all trial procedures
4) Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination
5) Group 2 only: Written documentation of complete primary series and fourth dose of DTP vaccine as per China National Immunization Recommendations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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
An individual fulfilling any of the following criteria had to be excluded from trial enrollment:
1) Group 1 only: For a woman of child-bearing potential, known pregnancy or positive serum or urine pregnancy test
2) Group 1 only: Currently breast-feeding a child
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
4) Planned participation in another clinical trial during the present trial period
5) 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
6) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine or to a vaccine containing any of the same substances
7) Chronic illness that, in the opinion of the Investigator, is at a stage that could interfere with trial conduct or completion
8) Group 1 only: Current alcohol abuse or drug addiction that may interfere with the ability to comply with trial procedures
9) Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
10) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C
11) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)
12) Previous fifth vaccination against pertussis disease and/or previous sixth vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except Tetanus-prone wound management in Group 1)
13) Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial, including persons who have exposure (e.g., member of a household with
another infected member, travelers to or residents of areas where one of this disease is hyperendemic or epidemic, or microbiologists routinely working with one of these pathogens)
14) Self-reported thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
15) Group 1 only: Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
16) History of contra-indication to vaccination with pertussis containing vaccine, including:
- Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that was not attributable to another identifiable cause
17) 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 immediate family members (i.e. husband, wife and their children, adopted or natural) of the employees or the Investigator.
Temporary Contraindications:
A prospective subject had not to be included in the study until the following conditions
and/or symptoms were resolved:
18) Febrile illness (axillary temperature =37.1°C) or moderate or severe acute illness/infection on the da
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: Vaccination:<br>Visit 1(Day 0): 1 dose of Adacel <br><br>Post-vaccination<br>Visit 2(Visit 1 + 8-10 days): staff reviewed the Day 0 to Day 7 safety data with subjects.<br>Visit 3 (Visit 1 + 28-35 days): staff reviewed the Day 8 to Day 28 safety datea with subjects.;Primary end point(s): The occurrence of any serious adverse reaction and Grade 3 adverse reaction occurring throughout the trial in each study group.;Main Objective: To describe the safety in terms of occurrence of serious adverse reactions and Grade 3 adverse<br>reactions after administration of Sanofi Pasteur’s Tdap vaccine (ADACEL) given as a single dose<br>in 20 adults and 20 children.;Secondary Objective: To describe the full reactogenicity profile after administration of Sanofi Pasteur’s Tdap vaccine<br>(ADACEL) given as a single dose in 20 adults and 20 children.
- Secondary Outcome Measures
Name Time Method