Status:
COMPLETED
Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Hepatitis B
Polio
Eligibility:
All Genders
50-71 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with Prevnar, ...
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Two month old infant (50 to 71 days old) on the day of inclusion, of either gender.
- Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg.
- Hepatitis B vaccination since birth.
- Informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate.
- 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.
- 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.
- Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy.
- Chronic illness at a stage that could interfere with trial conduct or completion.
- Blood or blood-derived products received since birth.
- Any vaccination in the 4 weeks preceding the first trial vaccination.
- Any planned vaccination (except trial vaccinations) during the trial.
- Documented history of pertussis, T, D, polio, Hib, hepatitis B or Streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically).
- Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b infection(s) or Streptococcus pneumoniae.
- Known personal or maternal history of HIV, HB (HbsAg carrier) or hepatitis C seropositivity.
- Known thrombocytopenia or bleeding disorder contraindicating IM vaccination.
- History of seizures.
- Febrile (rectal equivalent temperature \>= 38.0°C) or acute illness on the day of inclusion.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
412 Patients enrolled
Trial Details
Trial ID
NCT00401531
Start Date
October 1 2006
End Date
August 1 2008
Last Update
April 1 2014
Active Locations (2)
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1
Bangkok, Thailand
2
Khonkaen, Thailand