Immunogenicity of Adacel® and BOOSTRIX® Vaccines in Adolescents

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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