Evaluate Protective Efficacy of Diff Strengths of Human Rotavirus Vaccine After Admn of 2 Doses to Infants Aged 2 Months

Phase 2

Completed

• Conditions: Infections, Rotavirus

• Registration Number: NCT00385320
• Lead Sponsor: GlaxoSmithKline

Brief Summary

The purpose of this study is to test how infants respond to different strengths of the human rotavirus vaccine.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-05-31
• Primary Completion: 2003-04-30
• Study Completion: 2003-04-30
• Study First Submitted: 2006-10-06
• Study First Submitted QC: 2006-10-06
• Study First Posted: 2006-10-09
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2640

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of RV GE

Secondary Outcome Measures

Name	Time	Method
Serum RV IgA antibody titre, Viral shedding, Seroprotection/seropositivity status for DTPwHBVHib antigens, Solicited, unsolicited & SAE