EUCTR2015-005354-35-Outside-EU/EEAActive, not recruitingNot Applicable
Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™), Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18 to 19 Months of Age in Healthy Infants in South Africa.All Infants Receiving Hepatitis B Monovalent Vaccine at 6, 10 and 14 Weeks of Age.
SANOFI PASTEUR INTERNATIONA0 sites212 target enrollmentStarted: December 4, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 212
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) At Visit 01 (screening)
- •1) Aged < 24 hours on the day of inclusion
- •2) Born at full term pregnancy (>37 weeks) with a birth weight = 2.5 kg
- •3) Informed consent form signed by the parent(s) or other legal representative
- •4) Able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 212
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •At visit 01( screening):
- •1) Illness at a stage that could interfere with trial conduct or completion.
- •2) Any vaccination preceding the trial participation (except BCG)
- •3) Acute illness on the day of screening.
- •At visit 01 and visit 02 (screening & first study vaccination):
- •4) Planned participation in another clinical trial during the present trial period
- •5) Blood or blood–derived products received since birth.
- •6) Mother known as seropositive to HIV or Hepatitis B.
- •7) Known thrombocytopenia or a bleeding disorder contraindicating intramuscular
- •vaccination
- •8) History of/current seizures
- •At visit 02 (first study vaccination):
- •9) Participation in another clinical trial preceding the first trial vaccination
- •10) Congenital or acquired immunodeficiency, immunosuppressive therapy such as
- •long-term systemic corticosteroids therapy
- •11) Systemic hypersensitivity to any of the vaccine components or history of a lifethreatening
- •reaction to the trial vaccine or a vaccine containing the same substances
- •12) Chronic illness at a stage that could interfere with trial conduct or completion.
- •13) Any vaccination preceding the first trial vaccination (except BCG)
- •14) History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae
- •type b and hepatitis B infection (confirmed either clinically, serologically or
- •microbiologically).
- •15) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis
- •Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or
- •another vaccine.
- •16) Febrile illness (rectal temperature = 38.0°C or axillary temperature = 37.4°C) or
- •acute illness on the day of first vaccination
Investigators
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