Assess Efficacy, Immune Response & Safety of 2 Doses of Oral Live Attenuated HRV Vaccine at Different Viral Concentrations in Healthy Infants

Phase 2

Completed

• Conditions: Hepatitis B

• Registration Number: NCT00429481
• Lead Sponsor: GlaxoSmithKline

Brief Summary

To assess the efficacy, immune response and safety of 2 doses of HRV vaccine (at different concentrations) in healthy infants aged approximately 3 months previously uninfected with human rotavirus.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-01
• Primary Completion: 2003-04
• Study Completion: 2003-04
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-30
• Study First Posted: 2007-01-31
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2464

Inclusion Criteria

• Healthy infants 11 and 17 weeks of age at the time of the first vaccination, born after a normal gestation period (between 36 and 42 weeks).
• Written informed consent obtained from the parents or guardians of the subject.

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Exclusion Criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Previous vaccination against or history of or intercurrent diphtheria, tetanus, pertussis, polio and/or Hib.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. (Topical steroids are allowed.)
• Use of antibiotics during the period starting from 7 days before each dose of vaccine(s) and ending 7 days after.
• 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 HIV infection.
• History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
• GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
• Household contact with an immunosuppressed individual or pregnant woman.
• Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
• Previous confirmed occurrence of RV GE.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of any RV GE

Secondary Outcome Measures

Name	Time	Method
Occurrence of severe RV GE, rotavirus IgA antibody titres, solicited symptoms (Day 0-15), unsolicited Adverse Events (D0-42), Serious Adverse Events (full study),