Diphtheria, Haemophilus Infections, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphteria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, acellular
Brief summary
The present clinical study will assess the immunogenicity and reactogenicity of Sanofi Pasteur's DTacP-IPV// PRP\ T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 2, 4, and 6 months of age followed by a booster dose during the second year of life and concomitant hepatitis B vaccine at 2 and 6 months of age in infants in Thailand.
Interventions
BIOLOGICALDiphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
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
2 Months to 2 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 53 to 70 days inclusive on the day of inclusion
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 corticosteroid 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. * Mother known as seropositive to HIV or hepatitis B * Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin \[BCG\]) * History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically). * 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 (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 |
|---|---|
| Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine | 1 month post-vaccination |
Countries
Thailand
Outcome results
None listed