Rotavirus InfectionsPhase 2NCT03483116
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
A Phase 2 study testing RV3-BB in people with Rotavirus Infections, run by Murdoch Childrens Research Institute at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections
- What is being tested?
- RV3-BB
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 711 participants
- Where
- 1 siteMalawi
- Study dates
- 15 Jun 2018to 27 Jan 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 18 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Blantyre
About this study
Official title: 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.
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.
Read the 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.
- Conditions
- Rotavirus Infections
- Being tested
- RV3-BB, Placebo
- Keywords
- Dose ranging, Neonatal vaccine, RV3-BB vaccine
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RV3-BBBiological
Oral administration
PlaceboBiological
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| High dose RV3-BB neonatal schedule | Experimental | 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) Receives: Biological: RV3-BB; Biological: Placebo |
| Mid dose RV3-BB neonatal schedule | Experimental | 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) Receives: Biological: RV3-BB; Biological: Placebo |
| Low dose RV3-BB neonatal schedule | Experimental | 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) Receives: Biological: RV3-BB; Biological: Placebo |
| High dose RV3-BB infant schedule | Experimental | 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) Receives: Biological: RV3-BB; Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB
Cumulative anti rotavirus serum Immunoglobulin A (IgA) response is defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB
Measured: At serum collection at approximately 14 weeks of age
Secondary outcomes (9)
Number of Participants With a Cumulative Anti Rotavirus Serum IgA Response (≥3 Fold Increase From Baseline) After 3 Doses in an Infant RV3-BB Schedule
Defined as a ≥3 fold increase from baseline to 4 weeks after 3 doses of RV3-BB at 18 weeks of age
Measured: At serum collection visit approximately 18 weeks of age
Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule
Expressed as geometric mean titres (GMTs) from baseline to post dose 3 of RV3-BB Minimum 10 Maximum 250,000 Higher score considered to be immunogenic.
Measured: At serum collection time points at approximately 14 and 18 weeks of age
Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB.
Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose
Measured: Sample collections at Week 0 through to approximately 14 and 18 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB
Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational Product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose
Measured: Sample collections at Week 0 through to approximately 14 and 18 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB
Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose
Measured: Sample collections at Week 0 through to approximately 10 and 14 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB
Vaccine take is defined as at least a threefold increase in serum anti-rotavirus immunoglobulin A (IgA) from baseline to post Investigational product dosing, or detectable RV3 shedding in stools (by ELISA or PCR) any day from day three to day five following administration of Investigational product. Cumulative vaccine take is defined as Vaccine take observed at the current assessment time point or following any previous dose
Measured: Sample collections at Week 0 through to approximately 6 and 10 weeks of age
Occurrence of Adverse Events (AE)
Number of Participants with Adverse Events
Measured: First dose of investigational product to Study End at approximately 18 weeks of age
Occurrence of Serious Adverse Events (SAEs)
Number of participants with Serious Adverse Events (SAEs)
Measured: First dose of investigational product to Study End at approximately 18 weeks of age
Occurrence of Diarrhea. Severe
Diarrhea will be described according to severity and detection of wild type rotavirus in diarrhea samples collected. Severity defined using a modified version of the Vesikari clinical score for gastroenteritis. Severed is modified Vesikari score of greater than or equal to 11.
The Vesikari scale is a 20-point scale based on duration and peak frequency of diarrhea and vomiting, degree of temperature, severity of dehydration, and treatment provided to the patient (i.e., rehydration or hospitalization). This scale is divided into three ranges: mild <7, moderate 7-10, and severe ≥11
Measured: First dose of Investigational product to Study End at approximately 18 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start15 Jun 2018
- Primary completion27 Jan 2020
- Study completion27 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Desiree Witte, MD MTropPaed, Principal investigator, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483116
- Sponsor's protocol ID
- MCRI-RV3-BB-004
- Status last verified
- Jul 2023
- First submitted
- 23 Mar 2018
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified group data may be available for sharing on application to the Sponsor. This application must include the relevant proposal detailing the intended use of the data, the Ethics approval for this proposal and requires a signed data sharing agreement. Additional study documents including the study protocol, statistical analysis plan and informed consent are available on application to the Sponsor.
Publications
Witte D, Handley A, Jere KC, Bogandovic-Sakran N, Mpakiza A, Turner A, Pavlic D, Boniface K, Mandolo J, Ong DS, Bonnici R, Justice F, Bar-Zeev N, Iturriza-Gomara M, Ackland J, Donato CM, Cowley D, Barnes G, Cunliffe NA, Bines JE. Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study. Lancet Infect Dis. 2022 May;22(5):668-678. doi: 10.1016/S1473-3099(21)00473-4. Epub 2022 Jan 20.
PubMed 35065683Morgan B, Lyons EA, Handley A, Bogdanovic-Sakran N, Pavlic D, Witte D, Mandolo J, Turner A, Jere KC, Justice F, Ong DS, Bonnici R, Boniface K, Donato CM, Mpakiza A, Meyer A, Bar-Zeev N, Iturriza-Gomara M, Cunliffe NA, Danchin M, Bines JE. Rotavirus-Specific Maternal Serum Antibodies and Vaccine Responses to RV3-BB Rotavirus Vaccine Administered in a Neonatal or Infant Schedule in Malawi. Viruses. 2024 Sep 19;16(9):1488. doi: 10.3390/v16091488.
PubMed 39339964
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03483116
- Acronym / sponsor ID
- MCRI-RV3-BB-004
- Conditions
- Rotavirus Infections
- Keywords
- Dose ranging, Neonatal vaccine, RV3-BB vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 27 Jan 2020 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
| Arm | Type | Receives |
|---|---|---|
| High dose RV3-BB neonatal schedule | Experimental | Biological: RV3-BB, Biological: PlaceboHigh 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) |
| Mid dose RV3-BB neonatal schedule | Experimental | Biological: RV3-BB, Biological: PlaceboMid 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) |
| Low dose RV3-BB neonatal schedule | Experimental | Biological: RV3-BB, Biological: PlaceboLow 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) |
| High dose RV3-BB infant schedule | Experimental | Biological: RV3-BB, Biological: PlaceboHigh 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) |
Who may qualify
- Ages
- 0 days to 18 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RV3-BBOral administration | Biological | High dose RV3-BB infant schedule, High dose RV3-BB neonatal schedule, Low dose RV3-BB neonatal schedule, Mid dose RV3-BB neonatal schedule |
| PlaceboOral administration | Biological | High dose RV3-BB infant schedule, High dose RV3-BB neonatal schedule, Low dose RV3-BB neonatal schedule, Mid dose RV3-BB neonatal schedule |
Primary outcome
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB
Time frame: At serum collection at approximately 14 weeks of age
Cumulative anti rotavirus serum Immunoglobulin A (IgA) response is defined as a ≥3 fold increase from baseline at each serum collection time point to 4 weeks after 3 doses of RV3-BB
9 secondary outcomes
Number of Participants With a Cumulative Anti Rotavirus Serum IgA Response (≥3 Fold Increase From Baseline) After 3 Doses in an Infant RV3-BB Schedule
Time frame: At serum collection visit approximately 18 weeks of age
Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule
Time frame: At serum collection time points at approximately 14 and 18 weeks of age
Number of Participants With a Cumulative "Vaccine Take" (Serum Anti Rotavirus IgA Response or Shedding of RV3-BB Vaccine Virus) and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High Dose of RV3-BB.
Time frame: Sample collections at Week 0 through to approximately 14 and 18 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 3 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a Mid or Low Dose of RV3-BB
Time frame: Sample collections at Week 0 through to approximately 14 and 18 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 2 Doses of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB
Time frame: Sample collections at Week 0 through to approximately 10 and 14 weeks of age
Number of Participants With Cumulative Vaccine Take and Components of Vaccine Take After 1 Dose of RV3-BB Administered in a Neonatal or Infant Schedule at a High, Mid or Low Dose of RV3-BB
Time frame: Sample collections at Week 0 through to approximately 6 and 10 weeks of age
Occurrence of Adverse Events (AE)
Time frame: First dose of investigational product to Study End at approximately 18 weeks of age
Occurrence of Serious Adverse Events (SAEs)
Time frame: First dose of investigational product to Study End at approximately 18 weeks of age
Occurrence of Diarrhea. Severe
Time frame: First dose of Investigational product to Study End at approximately 18 weeks of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35065683Witte D, Handley A, Jere KC, Bogandovic-Sakran N, Mpakiza A, Turner A, Pavlic D, Boniface K, Mandolo J, Ong DS, Bonnici R, Justice F, Bar-Zeev N, Iturriza-Gomara M, Ackland J, Donato CM, Cowley D, Barnes G, Cunliffe NA, Bines JE. Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study. Lancet Infect Dis. 2022 May;22(5):668-678. doi: 10.1016/S1473-3099(21)00473-4. Epub 2022 Jan 20.
- Derived from this study: PubMed 39339964Morgan B, Lyons EA, Handley A, Bogdanovic-Sakran N, Pavlic D, Witte D, Mandolo J, Turner A, Jere KC, Justice F, Ong DS, Bonnici R, Boniface K, Donato CM, Mpakiza A, Meyer A, Bar-Zeev N, Iturriza-Gomara M, Cunliffe NA, Danchin M, Bines JE. Rotavirus-Specific Maternal Serum Antibodies and Vaccine Responses to RV3-BB Rotavirus Vaccine Administered in a Neonatal or Infant Schedule in Malawi. Viruses. 2024 Sep 19;16(9):1488. doi: 10.3390/v16091488.
- Individual participant dataSharing planned: Yes. Deidentified group data may be available for sharing on application to the Sponsor. This application must include the relevant proposal detailing the intended use of the data, the Ethics approval for this proposal and requires a signed data sharing agreement. Additional study documents including the study protocol, statistical analysis plan and informed consent are available on application to the Sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Desiree Witte, MD MTropPaed principal investigator
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RV3-BB in people with Rotavirus Infections, run by Murdoch Childrens Research Institute at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Cumulative Anti Rotavirus Serum Immunoglobulin A (IgA) Response (≥3 Fold Increase From Baseline) in Neonatal Vaccine Schedule at High Mid and Low Dose of RV3-BB (time frame: At serum collection at approximately 14 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483116, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.