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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

711 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2020-01-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

NCT04658914

Diarrhea Diarrhea Rotavirus

COMPLETED PHASE2

Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants

NCT00280111

Rotavirus Infections

COMPLETED PHASE1

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates

NCT04185545

Rotavirus Gastroenteritis

COMPLETED PHASE3

Development of a Live Attenuated Rotavirus Vaccine as a Human Infection Challenge Model

NCT04123119

Diarrhoeal Disease

COMPLETED NA

Reactogenicity, Safety and Immunological Efficacy of the Live, Pentavalent Rotavirus Vaccine in Childhood Immunization

NCT05032391

Rotavirus Infection

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective of this study is to assess the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in a neonatal schedule at a High, Mid or low vaccine titre. In addition the cumulative anti-rotavirus serum IgA response (defined as a ≥3 fold increase from baseline) 4 weeks after 3 doses of RV3-BB administered in an infant schedule at a high dose of vaccine will be assessed along with cumulative vaccine take and components of vaccine take after 3 doses of RV3-BB administered in a neonatal or infant schedule.

The safety and tolerability of RV3-BB when administered as an infant or as a neonatal schedule will be described.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotavirus Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High dose RV3-BB neonatal schedule

High dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)

Group Type EXPERIMENTAL

RV3-BB

Intervention Type BIOLOGICAL

Oral administration

Placebo

Intervention Type BIOLOGICAL

Oral administration

Mid dose RV3-BB neonatal schedule

Mid dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)

Group Type EXPERIMENTAL

RV3-BB

Intervention Type BIOLOGICAL

Oral administration

Placebo

Intervention Type BIOLOGICAL

Oral administration

Low dose RV3-BB neonatal schedule

Low dose neonatal RV3-BB vaccine schedule. RV3-BB Vaccine for Investigational product doses 1 (0-5 days), 2 (week 6) and 3 (week 10) and placebo for Investigational product dose 4 (week 14)

Group Type EXPERIMENTAL

RV3-BB

Intervention Type BIOLOGICAL

Oral administration

Placebo

Intervention Type BIOLOGICAL

Oral administration

High dose RV3-BB infant schedule

High dose infant RV3-BB vaccine schedule. Placebo for Investigational product dose 1 (0-5 days) and RV3-BB Vaccine for Investigational product doses 2 (week 6) 3 (week 10) and dose 4 (week 14)

Group Type EXPERIMENTAL

RV3-BB

Intervention Type BIOLOGICAL

Oral administration

Placebo

Intervention Type BIOLOGICAL

Oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

RV3-BB

Oral administration

Intervention Type BIOLOGICAL

Placebo

Oral administration

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neonate is less than 6 days (≤144 hours) of age at the time of first dose.
* Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator.
* Neonate birth weight 2500-4000g inclusive.
* Neonate's parents/guardians expect to be available for the duration of the study, and agree to adhere to all protocol requirements.
* Neonate's parents/guardians have provided written informed consent prior to study-related procedures being performed.

Exclusion Criteria

* Any medical, psychiatric, or social condition of a parent/guardian that in the opinion of the investigator would prevent the neonate's parents/guardians from giving proper informed consent or from complying with the study protocol.
* Neonates with known or suspected major congenital malformations or genetically determined disease.
* Neonates with intussusception.
* Neonates with a known or suspected bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
* Neonates who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of the study is anticipated.
* Neonates in whom Essential Programme Immunisation (EPI) vaccines or components are contraindicated.
* Neonates who have received or who expect to receive during the study period, any rotavirus vaccine other than those which will be administered as part of this study.
* Neonates who have ever received, or who are anticipated to receive during the study period, any investigational agent other than those which will be administered as part of this study.
* Neonates with a previous anaphylactic reaction to any drug, vaccine or vaccine component.
* Neonates with a significant evolving neurological disorder.
* Neonates whose parents/guardians are site team employees with direct involvement with the investigators, or who are working on the study.
* Neonates who have been exposed to immunosuppressive courses of glucocorticosteroids, cytotoxic drugs or blood products through prenatal exposure and/or breast milk in the four weeks prior to randomization.
* Neonates with diarrhoea or vomiting in the 24 hours preceding randomisation.
* Neonates with any moderate or severe illness, and/or who have a temperature of ≥37.5˚C axillary/oral or ≥38˚C rectal/tympanic within the 48 hours preceding randomization.

Minimum Eligible Age

0 Days

Maximum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes