Clinical trial NCT00254969: Immunogenicity and Safety of Pentaxim in South African Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Haemophilus Infections
Pertussis
Poliomyelitis
Keywords: Diphteria
tetanus
haemophilus influenzae type b
poliomyelitis
pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 212
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The present clinical study will assess the immunogenicity and reactogenicity 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 in order to meet the requirements for application for the use of the product in the Expanded Program on Immunization (EPI) in South Africa.


Eligibility criteria: Inclusion Criteria:

* Aged \< 24 hours on the day of inclusion

Exclusion Criteria:

* At visit 01 (screening)
* Illness at a stage that could interfere with trial conduct or completion.
* Any vaccination preceding the trial participation (except Bacille Calmette-Guerin \[BCG\])
* Acute illness on the day of screening. At visit 01 and visit 02 (screening and first study vaccination).
* Planned participation in another clinical trial during the present trial period
* Blood or blood-derived products received since birth.
* Mother known as seropositive to HIV or hepatitis B.
* Known thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures at visit 02 (first study vaccination)
* Participation in another clinical trial preceding the first trial vaccination
* 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.
* Any vaccination preceding the first trial vaccination (except BCG)
* History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection (confirmed either clinically, serologically or microbiologically).
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B infection with the trial vaccine or another vaccine.
* Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of first vaccination

Primary outcomes:
measure: To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine.
timeFrame: 1 month post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Soweto
country: South Africa
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Madhi SA, Cutland C, Jones S, Groome M, Ortiz E. One-year post-primary antibody persistence and booster immune response to a DTaP-IPV//PRP~T vaccine (Pentaxim) given at 18 - 19 months of age in South African children primed at 6, 10 and 14 weeks of age with the same vaccine. S Afr Med J. 2011 Nov 28;101(12):879-83.