Immunogenicity and Safety of Adacel Polio Vaccine

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Pertussis; Tetanus

Treatments: Biological: TdcP-IPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00797511

TD525

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

Study Group

Experimental group

Description:

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

Treatment:

Biological: TdcP-IPV vaccine