Brief Title
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.
Official Title
Immunogenicity and Safety of Sanofi Pasteur's Tdap Combined Vaccine (ADACEL) as a Booster Dose, Versus Local DT Vaccine in Healthy Children or Versus Local Td Vaccine in Healthy Adolescents and Adults in China
Brief Summary
The aim of the study is to assess the immunogenicity and safety profile of ADACEL compared to
local adsorbed diphtheria and tetanus combined vaccine (local DT or local Td vaccine in
participants in China.
Primary objective:
- To describe diphtheria and tetanus seroprotection rates and pertussis booster response
rates induced by each of the study vaccines: ADACEL vaccine (in all study age groups),
local DT vaccine (in children), and local Td vaccine (in adolescents and adults).
Secondary Objectives:
- To further describe in each group the immunogenicity of the study vaccines at baseline
and 1 month after vaccination.
- To describe the safety of the study vaccines
Detailed Description
Study participants will receive a single booster dose of ADACEL (Tdap vaccine) or a single
booster dose of local DT or local Td vaccine, depending on the age subgroup.
Immunogenicity will be assessed before and 28 days post-vaccination; safety profile will be
assessed in all subjects up to Day 35 post vaccination.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Percentage of participants with anti-diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL
Secondary Outcome
Percentage of participants with anti diphtheria antibody concentrations ≥ 0.1 international unit (IU)/mL at baseline
Condition
Diphtheria
Intervention
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL)
Study Arms / Comparison Groups
ADACEL Vaccine Group
Description: Children, adolescents and adults randomized to receive a single booster dose of ADACEL (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
1440
Start Date
November 2013
Completion Date
April 2015
Primary Completion Date
February 2014
Eligibility Criteria
Inclusion Criteria:
- Aged 4 through 64 years on day of inclusion
- For children and adolescents (4 through 17 years): Informed consent form has been
signed and dated by the parent(s) or another legally acceptable representative and
assent form has been signed and dated by the subject if aged 8 through 17 years
For adults (18 years and over): Informed consent form has been signed and dated by the
subject
- Subject and parent / legally acceptable representative (for subjects up to 17 years)
are able to attend all schedule visits and to comply with all trial procedures
- According to China National Immunization Recommendations, written documentation of
complete primary series and fourth dose of diphtheria, tetanus, pertussis (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
Exclusion Criteria:
- 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.
- 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.
- 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.
- Previous fifth vaccination against pertussis disease.
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
- 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.
- Known (laboratory-confirmed / self-reported) Human Immunodeficiency Virus (HIV) or
Hepatitis C seropositivity.
- History of diphtheria, tetanus, or pertussis infection (confirmed either clinically,
serologically or microbiologically).
- 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.
- Laboratory-confirmed / self-reported thrombocytopenia, contraindicating intramuscular
vaccination.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might
interfere with trial conduct or completion.
- 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
should not be included in the study until the condition has resolved or the febrile
event has subsided.
- History of contra-indication to vaccination with pertussis containing vaccine,
including:
- Encephalopathy (e.g, coma, decreased level of consciousness, prolonged seizures)
within 7 days of a previous dose of a pertussis containing vaccine that is 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.
- Prior personal history of Guillain-Barré syndrome.
- 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.
- Subject is 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 effective method of contraception or
abstinence from at least 4 weeks prior to the vaccination and until at least 4 weeks
after the vaccination.
Gender
All
Ages
4 Years - 64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01993173
Organization ID
Td528
Secondary IDs
U1111-1127-7835
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
May 2015