Clinical trial NCT00797511: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Keywords: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-11-25
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
timeFrame: Day 28 post-vaccination
measure: Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
timeFrame: Day 28 post-vaccination
measure: Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
timeFrame: Day 28 post-vaccination
measure: Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
timeFrame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Secondary outcomes:
measure: Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
timeFrame: Day 0 up to Day 7 post-vaccination
Other outcomes:
Locations:
city: Taipei
country: Taiwan
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References: