Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Haemophilus Influenzae Type b; Diphtheria; Pertussis; Tetanus

Treatments: Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib; Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00453570

E2I42

Details and patient eligibility

About

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.

Enrollment: 792 patients

Sex: All

Ages: 60 to 74 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Aged 2 months (60 to 74 days) inclusive on the day of inclusion
• Born at full term pregnancy (³36 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by the parent(s) or other legal representative
• Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

• Participation in another clinical trial in the 4 weeks preceding the trial inclusion
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
• Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received in the past
• Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
• Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
• History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
• Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
• Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of/current seizures
• Febrile illness (axillary temperature ≥ 37.1°C) or acute illness on the day of inclusion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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792 participants in 3 patient groups

1

Experimental group

Description:

DTacP IPV// PRP\~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.

Treatment:

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

2

Experimental group

Description:

DTacP-IPV// PRP\~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.

Treatment:

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib

3

Active Comparator group

Description:

Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age

Treatment:

Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed