Diphtheria, Haemophilus Influenzae Type b, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphteria, Tetanus, Haemophilus influenzae type b, Poliomyelitis, Pertussis
Brief summary
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.
Interventions
0.5 mL, IM
BIOLOGICALDiphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
0.5 mL, IM
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 74 Days
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine | 1 Month post-dose 3 |
Secondary
| Measure | Time frame |
|---|---|
| To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine | 19 months post-dose 1 |
Countries
China
Outcome results
None listed