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Trial registered on ANZCTR


Registration number
ACTRN12611001212943
Ethics application status
Approved
Date submitted
21/11/2011
Date registered
24/11/2011
Date last updated
7/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
RV3-BB Rotavirus Vaccine Phase IIa Clinical Trial of immunogenicity and safety.
Scientific title
A Phase IIa double-blind, randomised, placebo controlled study of the immunogenicity, safety, tolerability and reactogenicity of three doses of oral RV3-BB Rotavirus Vaccine, with the first dose of vaccine administered either at birth (0-5 days of age) or in infancy.
Secondary ID [1] 273411 0
Nil
Universal Trial Number (UTN)
U1111-1122-6381
Trial acronym
MCRI-RV3-BB-002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotavirus Gastroenteritis 279204 0
Condition category
Condition code
Infection 279406 279406 0 0
Other infectious diseases
Oral and Gastrointestinal 279407 279407 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 279408 279408 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each dose of RV3-BB rotavirus vaccine is 1ml sterile cell-free aqueous solution for oral administration, containing RV3-BB live naturally attenuated human rotavirus particles (at a concentration of 8.3E6 FFU/ml), in cell culture medium containing 10% sucrose.

Neonatal Schedule Arm participants will receive three 1ml doses of RV3-BB rotavirus vaccine, with the 1st dose administered at 0-5 days of age, followed by doses at approximately 9 weeks of age and approximately 15 weeks of age. To maintain blinding with the infant schedule arm, the participants in this arm will receive a 1ml dose of placebo at the end of the treatment period (approximately 23 weeks of age).

Infant Schedule Arm participants will receive three 1ml doses of RV3-BB rotavirus vaccine, with the 1st dose administered at approximately 9 weeks of age, followed by doses at approximately 15 weeks of age and approximately 23 weeks of age. To maintain blinding with the neonatal schedule arm, participants in this arm will receive a 1ml dose of placebo at 0-5 days of age.
Intervention code [1] 283746 0
Prevention
Intervention code [2] 283781 0
Treatment: Drugs
Comparator / control treatment
Placebo.
Each placebo dose is 1ml cell culture medium with 10% sucrose. Sterile aqueous cell-free solution for oral administration.

Participants in the Placebo Arm will receive 4 doses of placebo, with the 1st dose administered at 0-5 days of age, followed by doses at approximately 9 weeks of age, approximately 15 weeks of age and approximately 23 weeks of age.
Control group
Placebo

Outcomes
Primary outcome [1] 285981 0
Vaccine Take (defined as serum immune response or evidence of vaccine shedding in stool)
Timepoint [1] 285981 0
Serology assessments will be done on serum collected at baseline, and 28 days after dose 1, dose 3 (full neonatal vaccine schedule) and dose 4 (full infant vaccine schedule).
Shedding will be assessed in stool collected in the week after each dose.
Secondary outcome [1] 294892 0
Solicited adverse events
Timepoint [1] 294892 0
Solicited Systemic and Gastrointestinal adverse event data will be collected on diary cards in the days 0-7 following each dose. Events will be recorded as they occur.
Secondary outcome [2] 294893 0
Serious Adverse Events (SAE) and unsolicited adverse events
Timepoint [2] 294893 0
Unsolicited adverse event data, including and SAE, will be collected through observation and participant follow-up up from randomisation up to 28 days following the last dose of investigational product. Events will be recorded as they occur.

Eligibility
Key inclusion criteria
healthy, full-term infant, 0-5 days of age.
Minimum age
0 Days
Maximum age
5 Days
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Moderate or severe illness, major congenital malformations or genetically determined disease, known or suspected disease of the immune system, household member with severe immunosuppression, exposure to the following in the 4 weeks prior to enrolment (including gestation): glucocorticosteroids, cytotoxic drugs or blood products.
Intent to immunise with an investigational vaccine (during the study), or other rotavirus vaccine.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A computer-generated list of randomization codes will be supplied to the pharmacist involved in the study. At the point of enrolment, the investigator (or delegate) will call the pharmacist and ask for the next randomisation number on the list. That will be the participant number, which will be announced by the pharmacist to the investigator. The investigator and delegates will not be aware of the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be computer generated (by a statistician outside of the study team) using block randomisation, providing allocations for 120 participants in order to accommodate replacement of participants in the event of withdrawal prior to investigational product administration. Randomisation will be stratified by multiple births (single vs multiple).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3959 0
New Zealand
State/province [1] 3959 0
Otago

Funding & Sponsors
Funding source category [1] 284228 0
Government body
Name [1] 284228 0
National Health and Medical Research Council (NHMRC)
Address [1] 284228 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284228 0
Australia
Funding source category [2] 284229 0
Government body
Name [2] 284229 0
Health Research Council (HRC)
Address [2] 284229 0
Level 3 - ProCARE Building,
110 Stanley Street (access via Grafton Mews),
Auckland 1010
Country [2] 284229 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute (MCRI)
Address
Royal Children's Hospital
Flemington Road, Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 269184 0
None
Name [1] 269184 0
Address [1] 269184 0
Country [1] 269184 0
Other collaborator category [1] 260355 0
University
Name [1] 260355 0
University of Otago
Address [1] 260355 0
Clocktower Building
364 Leith Walk
Dunedin 9016
Country [1] 260355 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286191 0
Lower South Regional Ethics Committee
Ethics committee address [1] 286191 0
c/- Ministry of Health
1-3 The Terrace
Level 1
Wellington
6011
Ethics committee country [1] 286191 0
New Zealand
Date submitted for ethics approval [1] 286191 0
Approval date [1] 286191 0
08/11/2011
Ethics approval number [1] 286191 0
LRS/11/07/026
Ethics committee name [2] 286192 0
Royal Children's Hospital Human Research Ethics Committee (RCH HREC)
Ethics committee address [2] 286192 0
Royal Children's Hospital,
Flemington Road, Parkville Vic. 3052, Australia
Ethics committee country [2] 286192 0
Australia
Date submitted for ethics approval [2] 286192 0
Approval date [2] 286192 0
19/10/2011
Ethics approval number [2] 286192 0
31145

Summary
Brief summary
A phase I clinical trial completed in Melbourne in 2011 found the RV3-BB vaccine to be well-tolerated in adults, children and babies 6-8 weeks of age. The aim of this phase IIa trial is to determine the extent of the immune response (or protection) that is created in babies receiving the vaccine. We are including newborn babies in this trial, as we believe receiving this vaccine at birth will offer the earliest and possibly greatest protection. We are inviting 93 Dunedin families, with newborn babies to take part in this trial.

Each of the babies will be randomly assigned to groups, so that two thirds of the babies will receive 3 doses of oral RV3 vaccine and one third of the babies will receive oral doses of placebo. In total each baby’s involvement will include 7 visits, with the first visit in the first 5 days of the baby’s life, and the final visit at approximately 6 months of age.
Trial website
www.mcri.edu.au/rv3
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33409 0
Prof Barry Taylor
Address 33409 0
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 33409 0
New Zealand
Phone 33409 0
+64 3 474 7874
Fax 33409 0
Email 33409 0
barry.taylor@otago.ac.nz
Contact person for public queries
Name 16656 0
Prof Professor Julie Bines
Address 16656 0
Rotavirus Research Group
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country 16656 0
Australia
Phone 16656 0
+61 3 9345 4107
Fax 16656 0
Email 16656 0
jebines@unimelb.edu.au
Contact person for scientific queries
Name 7584 0
A/Prof Associate Professor Carl Kirkwood
Address 7584 0
Rotavirus Research Group
Murdoch Childrens Research Institute
Royal Children's Hospital
Flemington Road Parkville Victoria 3052 Australia
Country 7584 0
Australia
Phone 7584 0
+61 3 8341 6448
Fax 7584 0
Email 7584 0
carl.kirkwood@mcri.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary