Immunogenicity and Safety of Adacel Polio Vaccine

Brief Title

Immunogenicity and Safety of Adacel Polio Vaccine

Official Title

Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan

Brief Summary

      The present study is designed to meet the requirements of the Taiwanese Health Authorities
      for registration of ADACEL POLIO in Taiwan.

      Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples
      will be taken for antibody titration. The expected total duration of follow-up for each
      subject will be 28 days.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.

Secondary Outcome

 Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine

Condition

Diphtheria

Intervention

TdcP-IPV vaccine

Study Arms / Comparison Groups

 Study Group

Description:  Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

132

Start Date

November 2008

Completion Date

July 2009

Primary Completion Date

April 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Aged 6 to 8 years on the day of inclusion

          -  Informed consent form signed by the parent(s) or another legally acceptable
             representative

          -  Subject and parent/guardian able to attend all scheduled visits and comply with all
             trial procedures

          -  Written documentation of complete primary series and fourth dose of diphtheria,
             tetanus, pertussis (DTP) and Polio vaccines

          -  Parent(s)/legal representative present or fully completed pre-inclusion medical
             questionnaire.

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  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

          -  Known systemic hypersensitivity to any of the vaccine components (or residues carried
             over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin
             and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to
             a vaccine containing any of the same substances with specific focus on subjects who
             had, after previous administration of DTP vaccine, one of the pre-listed adverse
             events.

          -  Chronic illness, at a stage that could interfere with trial conduct or completion, in
             the opinion of the investigator

          -  Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy,
             progressive encephalopathy

          -  Receipt of blood or blood-derived products in the past 3 months, that might interfere
             with the assessment of immune response

          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination

          -  Planned receipt of any vaccine in the 4 weeks following the trial vaccination

          -  Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or
             Hepatitis C seropositivity

          -  History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection
             (confirmed either clinically, serologically or microbiologically)

          -  Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or
             poliomyelitis diseases with either the trial vaccine or another vaccine

          -  Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding
             inclusion contraindicating intramuscular (IM) vaccination

          -  Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or
             poliomyelitis infection during the trial

          -  Received oral or injected antibiotic therapy within the 72 hours prior to any blood
             draw

          -  Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection
             on the day of vaccination, according to investigator judgment
      

Gender

All

Ages

6 Years - 8 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Monitor, , 

Location Countries

Taiwan

Location Countries

Taiwan

NCT ID

NCT00797511

Organization ID

TD525

Responsible Party

Sponsor

Study Sponsor

Sanofi

Study Sponsor

Medical Monitor, Study Director, Sanofi Pasteur Inc.

Verification Date

October 2012