Brief Title
Study of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed in Healthy Subjects
Official Title
Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (SP0173) in Healthy Adolescents, Adults, and Older Adults
Brief Summary
This was a dose and formulation ranging study to assess the safety and immunogenicity of
SP0173 in healthy adolescents, adults, and older adults in the United States (US).
Primary Objective
- To describe the safety profile of each SP0173 investigational formulation.
Observational Objective:
- To describe the immunogenicity of each SP0173 investigational formulation.
Detailed Description
All participants received a single dose of vaccine, and were assessed for immunogenicity at
baseline (pre-vaccination) and at 30 days post-vaccination. They were also monitored for
safety from day of vaccination up to Day 180 post-vaccination.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Number of Participants With Solicited Injections Site or Systemic Reactions Following Vaccination at Day 0: Aged 10-18 Years
Condition
Tetanus
Intervention
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1
Study Arms / Comparison Groups
Adolescents: SP0173 Formulation 1
Description: Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
1363
Start Date
October 22, 2015
Completion Date
February 21, 2017
Primary Completion Date
February 21, 2017
Eligibility Criteria
Inclusion Criteria:
- Aged 10 to 18 years, 19 to 64 years, or >= 65 years on the day of inclusion.
- Informed consent form had been signed and dated by the participant, or assent form had
been signed and dated by the participant and informed consent form had been signed and
dated by the parent/guardian
- Participant or participant and parent/guardian able to attend all scheduled visits and
to comply with all study procedures.
Exclusion Criteria:
- Participant was pregnant, or lactating, or of childbearing potential, (to be
considered of non-childbearing potential, a female must be premenarche or
post-menopausal for at least 1 year) surgically sterile, or using an effective method
of contraception or abstinence from at least 4 weeks prior to vaccination until at
least 4 weeks after vaccination.
- Participation at the time of study enrollment or planned participation during the
present study period in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure.
- Received any vaccine in the 4 weeks preceding the trial vaccination or planned receipt
of any vaccine between Visit 1 and Visit 2.
- Known or suspected receipt of a tetanus toxoid, reduced diphtheria toxoid, and
Acellular pertussis (Tdap) vaccine or Tdap-containing vaccine at any point in time, or
receipt of a tetanus and diphtheria containing vaccine in the preceding 5 years.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- Known or suspected 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.
- History of diphtheria, tetanus, or pertussis infection (confirmed either serologically
or microbiologically).
- Known or suspected systemic hypersensitivity to any of the vaccine components or
history of life-threatening reaction to the study vaccine or a vaccine containing the
same substances.
- Laboratory-confirmed / self-reported thrombocytopenia or bleeding disorder
contraindicating intramuscular vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination.
- History of encephalopathy (e.g., coma, decreased level of consciousness, or prolonged
seizures) not attributable to another identifiable cause within 7 days of
administration of a previous dose of diphtheria and tetanus toxoids and pertussis
(DTP), or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine.
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- Chronic illness that was at a stage where it might interfere with trial conduct or
completion.
- Moderate or severe acute illness/infection on the day of vaccination or febrile
illness (temperature >= 100.4°F).
- 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.
Gender
All
Ages
10 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02587520
Organization ID
ADC01
Secondary IDs
U1111-1161-3027
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
February 2020