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A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.

NCT03483116•Murdoch Childrens Research Institute

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

Locations (1)

Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Blantyre, Malawi

Key Dates

Start Date

June 15, 2018

Primary Completion Date

January 27, 2020

Completion Date

January 27, 2020

Last Updated

July 10, 2023

Enrollment

711

ACTUAL participants

Conditions

Rotavirus Infections

Interventions

RV3-BB

BIOLOGICAL

Placebo

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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