Sanofi Pasteur’s Tdap Combined Vaccine as a Booster versus Local DT Vaccine in Children or versus Local Td Vaccine in Adolescents and Adults 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] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-003941-24-Outside-EU/EEA
- Lead Sponsor
- SANOFI PASTEUR SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 1200
An individual had to fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 4 through 64 years on the day of inclusion
2) For children and adolescents (4 through 17 years): Informed consent form (ICF) signed and dated by the parent(s) or another legally acceptable representative and assent form signed and dated by the subject if aged 8 through 17 years
For adults (18 years and over): ICF signed and dated by the subject
3) Subject and parent / legally acceptable representative (for subjects up to 17 years) able to attend all schedule visits and to comply with all trial procedures
4) According to China National Immunization Recommendations, written documentation of complete primary series and fourth dose of DTP vaccine for subjects aged 4 through 7 years and a written documentation or oral confirmation of complete primary series and fourth dose of DTP vaccine for subjects aged 8 through 64 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 720
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
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 was to be excluded from trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination
3) Previous vaccination against diphtheria and tetanus disease with either the trial vaccine or another vaccine (except tetanus-prone wound management for adults) in the past 12 months
4) Previous fifth vaccination against pertussis disease
5) Receipt of immune globulins, blood or blood-derived products in the past 3 months
6) 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
7) Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or Hepatitis C seropositivity
8) History of diphtheria, tetanus, or pertussis infection (confirmed either clinically, serologically or microbiologically)
9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
10) Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular vaccination
11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
12) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
13) Chronic illness that, in the opinion of the Investigator, was at a stage where it could interfere with trial conduct or completion
14) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 37.1°C). A prospective subject could not be included in the study until the condition had resolved or the febrile event had subsided.
15) 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
• Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy
• Axillary temperature >39.4°C within 48 hours not attributable to another identifiable cause
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
16) Prior personal history of Guillain-Barré syndrome
17) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
18) Subject was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post menopausal for at least 1 year, surgically sterile, or using an effectiv
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