Diphtheria, Haemophilus Infections, Pertussis, Polio, Tetanus
Conditions
Keywords
Diphteria, Tetanus, Polio, Acellular Pertussis, Hib, Haemophilus influenzae type B
Brief summary
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP\ T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life. Safety: This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
Interventions
BIOLOGICALDiphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
42 Days to 56 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 42 to 56 days inclusive on the day of inclusion * Born at full term pregnancy (\> 37 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 (first) trial vaccination * 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 preceding the trial vaccination (except BCG and hepatitis B) * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically). * Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine. * Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * History of/current seizures * Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine | 19 months |
Countries
India
Outcome results
None listed