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Immunogenicity and Safety of Adacel Polio Vaccine

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ClinicalTrials.gov Identifier: NCT00797511
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : November 26, 2012
Last Update Posted : November 26, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE November 24, 2008
First Posted Date  ICMJE November 25, 2008
Results First Submitted Date  ICMJE October 24, 2012
Results First Posted Date  ICMJE November 26, 2012
Last Update Posted Date November 26, 2012
Study Start Date  ICMJE November 2008
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
  • Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine. [ Time Frame: Day 28 post-vaccination ]
    Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
  • Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine. [ Time Frame: Day 28 post-vaccination ]
    The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
  • Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination [ Time Frame: Day 28 post-vaccination ]
    Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
  • Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
Original Primary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
To provide information concerning the immunogenicity of Adacel Polio after booster vaccination. [ Time Frame: one month after vaccination ]
Change History Complete list of historical versions of study NCT00797511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2012)
Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine [ Time Frame: Day 0 up to Day 7 post-vaccination ]
Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 24, 2008)
To provide information concerning the safety of Adacel Polio after booster administration. [ Time Frame: one month after vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of Adacel Polio Vaccine
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
Intervention  ICMJE Biological: TdcP-IPV vaccine
0.5 mL, Intramuscular
Other Name: ADACEL POLIO
Study Arms  ICMJE Experimental: Study Group
Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
Intervention: Biological: TdcP-IPV vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2008)
132
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00797511
Other Study ID Numbers  ICMJE TD525
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP