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A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine

NCT03483116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 711

Last updated 2023-07-10

Study results available
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Summary

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

Conditions

  • Rotavirus Infections

Interventions

BIOLOGICAL

RV3-BB

Oral administration

BIOLOGICAL

Placebo

Oral administration

Sponsors & Collaborators

  • Murdoch Childrens Research Institute

    lead OTHER

Principal Investigators

  • Desiree Witte, MD MTropPaed · Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
18 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-15
Primary Completion
2020-01-27
Completion
2020-01-27
FDA Drug
Yes

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483116 on ClinicalTrials.gov