A Phase 2 interventional study of RV3-BB and Placebo in Rotavirus Infections, sponsored by Murdoch Childrens Research Institute. Completed at 1 site in Malawi. Open to participants aged 0 Days to 18 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Murdoch Childrens Research Institute · Phase 2, Interventional, and Prevention
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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.
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.
104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 711 is above the median of 403 across 69 interventional studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Biological: RV3-BB · Biological: Placebo
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)
Biological: RV3-BB · Biological: Placebo
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)
Biological: RV3-BB · Biological: Placebo
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)
Biological: RV3-BB · Biological: Placebo
Oral administration
Oral administration
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
Time frame: At serum collection at approximately 14 weeks of age
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
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
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.
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.
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
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
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
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
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
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
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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: First dose of Investigational product to Study End at approximately 18 weeks of age
A two-stage consent process was followed: * Pregnant women were invited to provide preliminary consent during the third trimester and prior to going into labour. * Post birth, the parents/guardians were invited to provide consent for their baby to participate in the study.
| Milestone | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Started | 178 | 179 | 175 | 179 |
| Completed | 150 | 156 | 149 | 148 |
| Not completed | 28 | 23 | 26 | 31 |
| Withdrew: Adverse event | 0 | 1 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 7 |
| Withdrew: Lost to follow-up | 9 | 4 | 9 | 5 |
| Withdrew: Death | 1 | 0 | 2 | 1 |
| Withdrew: Withdrawal by subject | 14 | 16 | 14 | 16 |
| Withdrew: Unknown other reason | 3 | 2 | 1 | 1 |
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
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule |
|---|---|---|---|
| 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 | 79 | 80 | 57 |
Defined as a ≥3 fold increase from baseline to 4 weeks after 3 doses of RV3-BB at 18 weeks of age
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| 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 | 100 | 96 | 86 | 82 |
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.
| geometric mean titres | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Serum Anti Rotavirus IgA Titres in Participants Receiving RV3-BB in a Neonatal or Infant Schedule | 48.4 ± 22339.87 | 39.9 ± 21758.64 | 28.0 ± 7724.19 | 77.7 ± 25020.69 |
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
| participants | High Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|
| Vaccine take | 118 | 120 |
| Serum IgA | 79 | 82 |
| Shedding RV3-BB vaccine virus | 85 | 90 |
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
| participants | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule |
|---|---|---|
| Vaccine take | 114 | 94 |
| Serum IgA | 80 | 57 |
| RV3-BB Vaccine Shedding | 71 | 62 |
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
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Vaccine take | 98 | 89 | 68 | 98 |
| Serum IgA | 56 | 55 | 31 | 58 |
| RV3-BB vaccine shedding | 69 | 52 | 46 | 70 |
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
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Vaccine take | 51 | 45 | 23 | 64 |
| Serum IgA | 31 | 31 | 12 | 26 |
| RV3-BB vaccine shedding | 29 | 15 | 12 | 48 |
Number of Participants with Adverse Events
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Occurrence of Adverse Events (AE) | 67 | 68 | 69 | 60 |
Number of participants with Serious Adverse Events (SAEs)
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Occurrence of Serious Adverse Events (SAEs) | 11 | 7 | 8 | 5 |
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
| participants | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Occurrence of Diarrhea. Severe | 1 | 2 | 2 | 0 |
Collected over 18 weeks. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose RV3-BB Neonatal Schedule | 1/170 (0.6%) | 11/170 (6.5%) | 67/170 (39.4%) |
| Mid Dose RV3-BB Neonatal Schedule | 0/172 (0%) | 7/172 (4.1%) | 68/172 (39.5%) |
| Low Dose RV3-BB Neonatal Schedule | 2/169 (1.2%) | 8/169 (4.7%) | 69/169 (40.8%) |
| High Dose RV3-BB Infant Schedule | 1/173 (0.6%) | 5/173 (2.9%) | 59/173 (34.1%) |
| Event | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| BronchiolitisInfections and infestations | 3/170 | 3/172 | 2/169 | 1/173 |
| Sepsis NeonatalInfections and infestations | 3/170 | 1/172 | 1/169 | 1/173 |
| SepsisInfections and infestations | 1/170 | 0/172 | 2/169 | 0/173 |
| Jaundice NeonatalPregnancy, puerperium and perinatal conditions | 2/170 | 0/172 | 0/169 | 0/173 |
| GastroenteritisInfections and infestations | 1/170 | 0/172 | 1/169 | 0/173 |
| PneumoniaInfections and infestations | 1/170 | 0/172 | 1/169 | 0/173 |
| Femur FractureInjury, poisoning and procedural complications | 0/170 | 0/172 | 1/169 | 0/173 |
| AsphyxiaRespiratory, thoracic and mediastinal disorders | 1/170 | 0/172 | 1/169 | 0/173 |
| Breast AbscessInfections and infestations | 0/170 | 1/172 | 0/169 | 0/173 |
| ConstipationGastrointestinal disorders | 0/170 | 1/172 | 0/169 | 0/173 |
| Event | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule |
|---|---|---|---|---|
| Upper Respiratory tract infectionInfections and infestations | 15/170 | 16/172 | 16/169 | 11/173 |
| NasopharyngitisInfections and infestations | 11/170 | 7/172 | 5/169 | 5/173 |
| Respiratory tract infectionInfections and infestations | 6/170 | 4/172 | 10/169 | 4/173 |
| DiarrhoeaGastrointestinal disorders | 7/170 | 10/172 | 9/169 | 4/173 |
| BronchiolitisInfections and infestations | 8/170 | 10/172 | 6/169 | 5/173 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/170 | 6/172 | 8/169 | 2/173 |
| GastroenteritisInfections and infestations | 3/170 | 8/172 | 5/169 | 7/173 |
| Opthalmia NeonatorumInfections and infestations | 4/170 | 6/172 | 3/169 | 8/173 |
| PyrexiaGeneral disorders | 5/170 | 6/172 | 5/169 | 4/173 |
| PneumoniaInfections and infestations | 4/170 | 5/172 | 4/169 | 1/173 |
| Age, Categorical(Participants) | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule | Total |
|---|---|---|---|---|---|
| <=18 years | 178 | 179 | 175 | 179 | 711 |
| Between 18 and 65 years | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(Days) | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule | Total |
|---|---|---|---|---|---|
| Mean | 1.4 ± 1.5 | 1.4 ± 1.42 | 1.4 ± 1.45 | 1.5 ± 1.39 | 1.5 ± 1.43 |
| Sex: Female, Male(Participants) | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule | Total |
|---|---|---|---|---|---|
| Female | 101 | 84 | 88 | 96 | 369 |
| Male | 77 | 95 | 87 | 83 | 342 |
| Race (NIH/OMB)(Participants) | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 178 | 179 | 175 | 179 | 711 |
| White | 0 | 0 | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | High Dose RV3-BB Neonatal Schedule | Mid Dose RV3-BB Neonatal Schedule | Low Dose RV3-BB Neonatal Schedule | High Dose RV3-BB Infant Schedule | Total |
|---|---|---|---|---|---|
| Malawi | 178 | 179 | 175 | 179 | 711 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: For 24 months from publication of the primary outcome.
Access criteria: Data access agreement Approval by local Ethics committee
Ran from Jun 2018 to primary completion in Jan 2020, 19 months.
Results were first posted in Jul 2023, 3 years 5 months after primary completion.
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Murdoch Childrens Research Institute