Status:
COMPLETED
Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
6-19 years
Phase:
PHASE4
Brief Summary
The present clinical study will assess the immunogenicity and reactogenicity of the subsequent administration of Aventis Pasteur's DTacP-IPV//PRP\~T combined vaccine (PENTAVAC™/PENTAXIM), as a three-d...
Detailed Description
Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows: Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 1...
Eligibility Criteria
Inclusion
- Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
- Healthy male or female newborn
- Age ranging from birth to 48 hours of life (included)
- Birth weight \>2.5 kg and gestational age \>37 weeks
- Born to HBs antigen-negative mother
Exclusion
- Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
- Infant presently enrolled or scheduled to be enrolled in another clinical trial
- Infant with moderate or severe illness, mainly infectious diseases
- Infant with fever (rectal temperature \> 38°C or axillary temperature \> 37.5°C)
- Infant with severe congenital defects or abnormalities
- Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Known immunological deficiency (including a known HIV seropositive mother)
- Administration of vaccine since birth (other than BCG)
- Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
387 Patients enrolled
Trial Details
Trial ID
NCT00254917
Start Date
October 1 2003
End Date
February 1 2006
Last Update
April 16 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Manila, Philippines