Status:
COMPLETED
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
Lead Sponsor:
Murdoch Childrens Research Institute
Conditions:
Rotavirus Infections
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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 infa...
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 neonat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
711 Patients enrolled
Trial Details
Trial ID
NCT03483116
Start Date
June 15 2018
End Date
January 27 2020
Last Update
July 10 2023
Active Locations (1)
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1
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre, Malawi