Brief Title
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Official Title
Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents
Brief Summary
The aim of this study is to describe immunogenicity of a single booster dose of Adacel
vaccine versus Boostrix vaccine among approximately 420 adolescents 11 to <13 years of age.
Primary objective:
- To describe seroprotection rates against tetanus and diphtheria in subjects randomized
to receive either Adacel or Boostrix vaccine.
Observational objectives:
- To describe pre- and post-vaccination tetanus, diphtheria, and pertussis geometric mean
antibody concentrations (GMCs) in subjects randomized to receive either Adacel or
Boostrix vaccine.
- To describe booster response rates against tetanus, diphtheria, and pertussis in
subjects randomized to receive either Adacel or Boostrix vaccine.
- To describe the rates of adverse events (AEs) immediately post-vaccination, and the
rates of unsolicited AEs and serious adverse events (SAEs) following vaccination with
Adacel or Boostrix vaccine from Visit 1 through Visit 2.
Detailed Description
Participants will be randomized in a 1:1 ratio to receive either Adacel or Boostrix vaccine.
Subjects will be monitored for immediate reactions for 15 minutes post-vaccination.
Unsolicited adverse events and serious adverse events will be collected from Visit 1 through
Visit 2.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Number of Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Secondary Outcome
Geometric Mean Concentrations of Tetanus and Diphtheria Antibodies Following Vaccination With Either Adacel® or BOOSTRIX® Vaccine
Condition
Tetanus
Intervention
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Study Arms / Comparison Groups
Adacel® Vaccine Group
Description: Participants randomized to receive a single dose of Adacel® 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
423
Start Date
June 2012
Completion Date
June 2013
Primary Completion Date
March 2013
Eligibility Criteria
Inclusion Criteria:
- Subject is 11 to < 13 years of age at the time of vaccination
- Received exactly 5 doses of pertussis vaccine at < 7 years of age
- Informed consent and assent forms have been signed and dated
- Subject is able to attend all scheduled visits and to comply with all trial
procedures.
Exclusion Criteria:
- Subject is pregnant, or lactating, or of child bearing potential without using an
effective method of contraception or not practicing abstinence for at least 4 weeks
prior to vaccination and until at least 4 weeks after vaccination
- Any condition that, in the opinion of the Investigator, would pose a health risk to
the participant or interfere with the evaluation of the vaccine
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might
interfere with trial conduct or completion
- 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)
- Known or suspected receipt of any whole-cell pertussis-containing vaccine
- A personal history of physician-diagnosed or laboratory-confirmed pertussis disease
within the last 2 years
- 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
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- 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
- Receipt of any vaccine within 30 days before 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 less than 15 days) before receiving study
vaccine
- Participation in another interventional clinical trial investigating a vaccine, drug,
medical device, or medical procedure in the 30 days preceding the first study
vaccination or during the course of the study, at the discretion of the Sponsor
- Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C, as
reported by the subject's parent/guardian
- Laboratory-confirmed thrombocytopenia, which may be a contraindication for
intramuscular (IM) vaccination, at the discretion of the Investigator
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,
which may be a contraindication for IM vaccination, at the discretion of the
Investigator
- Personal history of Guillain-Barré syndrome
- Moderate or severe acute illness/infection (according to Investigator judgment) or
febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. (A
prospective subject should not be enrolled in the study until the condition has
resolved or the febrile event has subsided.)
- 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
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily
- Current alcohol or drug use that, in the opinion of the Investigator, might interfere
with the ability to comply with trial procedures.
Gender
All
Ages
11 Years - 12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01629589
Organization ID
Td551
Secondary IDs
U1111-1127-6774
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
February 2016