Status:
COMPLETED
Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.
Eligibility Criteria
Inclusion
- Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks or a birth weight of \>2000g.
- Written informed consent obtained from the parent or guardian of the subject.
Exclusion
- Planned administration of oral polio vaccine during the period starting from 2 weeks before each dose of study vaccine(s) and ending 2 weeks after.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- History of diphtheria, tetanus, pertussis, Hib disease and/ or hepatitis B.
- Previous vaccination against diphtheria, tetanus, pertussis, and/or Haemophilus influenzae type b.
- History of allergic disease
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of the vaccination)
- Previous confirmed occurrence of RV GE.
- Household contact with an immunosuppressed individual or pregnant women.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period
Key Trial Info
Start Date :
May 31 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2003
Estimated Enrollment :
2640 Patients enrolled
Trial Details
Trial ID
NCT00385320
Start Date
May 31 2001
End Date
April 30 2003
Last Update
December 27 2019
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