RV3-BB Rotavirus Vaccine Phase IIb Clinical Trial of efficacy, safety and immunogenicity

Phase 2

Completed

• Conditions: Rotavirus gastroenteritis; Infection - Other infectious diseases; Public Health - Epidemiology; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612001282875
• Lead Sponsor: Murdoch Children's Research Institute (MCRI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1647

Inclusion Criteria

Healthy full-term baby 0 - 5 days of age.

Exclusion Criteria

Major congenital malformations or genetically determined disease, intussusception,
immune system disease, prior receipt of (or exposure in utero to) immunosuppressive therapy, cytotoxic or hepatotoxic drugs, bleeding diathesis, significant evolving neurological disorder, previous anaphylactic reaction, contraindication of EPI vaccines or components, receipt of any other rotavirus vaccine, vomiting, diarrhoea or fever in 24 hours prior to first dose.

Study & Design

• Study Type: Interventional
• Study Design: Not specified