Status:
COMPLETED
Study of Two Doses of GSK Biologicals' Live Attenuated HRV Vaccine (Two Different Formulations) in Healthy Infants.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 mo...
Detailed Description
All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset). The third dose of IPV vaccine (IPOL) may...
Eligibility Criteria
Inclusion
- A male or female child between, and including 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the parents or guardians of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine or placebo or planned use during the study period.
- Planned administration of a vaccine (including routine pediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of vaccine(s) and ending 14 days after. Hepatitis B vaccine given concomitantly or within 14 days before and after vaccination is not an exclusion criteria.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- History of diphtheria, tetanus, pertussis, polio, Hib disease and/or invasive pneumococcal infection. History of invasive pneumococcal infection is not an exclusion criteria for Canadian subjects.
- Previous vaccination against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, and/or Streptococcus pneumoniae. Previous vaccination against Streptococcus pneumoniae is not an exclusion criteria for Canadian subjects.
- Use of antibiotics within 7 days preceding dose 1.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrollment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- 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.
- Previous confirmed occurrence of rotavirus gastroenteritis.
- Inability to contact parents/guardians of the subject by telephone.
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2002
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT00729001
Start Date
November 1 2000
End Date
September 1 2002
Last Update
September 16 2016
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