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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RV3-BB | Biological | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At serum collection at approximately 14 weeks of age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At serum collection visit approximately 18 weeks of age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Desiree Witte, MD MTropPaed | Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Malawi-Liverpool-Wellcome Trust Clinical Research Programme | Blantyre | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35065683 | Background | 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. | |
| 39339964 |
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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.
For 24 months from publication of the primary outcome.
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A two-stage consent process was followed:
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| FG001 | Mid Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| FG002 | Low Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| FG003 | High Dose RV3-BB Infant Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Per protocol population | Posted | Number | participants | At serum collection at approximately 14 weeks of age |
|
18 weeks
Adverse events were reported for the safety analysis set. The safety analysis set includes all randomised participants who received at least one dose of investigational product. Participants will be analysed according to the treatment received. Conditions identified as a congenital anomaly or birth defect, regardless of when the condition is identified, were not be recorded as SAEs unless the condition progressed/worsened or was fatal. These conditions were recorded as medical history.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Julie Bines | Murdoch Children's Research Institute | +61 3 9345 5522 | julie.bines@mcri.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2019 | May 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 28, 2020 | May 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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This is a Phase II, randomised, double-blind, placebo-controlled, four-arm parallel group study of two different dosing schedules of oral RV3-BB
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| Placebo | Biological | Oral administration |
|
| 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. |
| 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 | 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 | 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 | 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 | 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 | 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) | 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 | First dose of Investigational product to Study End at approximately 18 weeks of age |
| Derived |
| Morgan 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. |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Death |
|
| Withdrawal by Subject |
|
| Unknown other reason |
|
| Mid Dose RV3-BB Neonatal Schedule |
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) RV3-BB: Oral administration Placebo: Oral administration |
| BG002 | Low Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| BG003 | High Dose RV3-BB Infant Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age at first dose of investigational product | Full analysis Set (27 missing) | Mean | Standard Deviation | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Mid Dose RV3-BB Neonatal Schedule |
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) RV3-BB: Oral administration Placebo: Oral administration |
| OG002 | Low Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration |
|
|
|
| Secondary | 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 | Per protocol population | Posted | Number | participants | At serum collection visit approximately 18 weeks of age |
|
|
|
| Secondary | 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. | Per protocol | Posted | Geometric Mean | Standard Deviation | geometric mean titres | At serum collection time points at approximately 14 and 18 weeks of age |
|
|
|
| Secondary | 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 | Per protocol analysis | Posted | Number | participants | Sample collections at Week 0 through to approximately 14 and 18 weeks of age |
|
|
|
| Secondary | 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 | Per protocol analysis | Posted | Number | participants | Sample collections at Week 0 through to approximately 14 and 18 weeks of age |
|
|
|
| Secondary | 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 | Per protocol population | Posted | Number | participants | Sample collections at Week 0 through to approximately 10 and 14 weeks of age |
|
|
|
| Secondary | 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 | Per protocol population | Posted | Number | participants | Sample collections at Week 0 through to approximately 6 and 10 weeks of age |
|
|
|
| Secondary | Occurrence of Adverse Events (AE) | Number of Participants with Adverse Events | Safety Analysis Set | Posted | Number | participants | First dose of investigational product to Study End at approximately 18 weeks of age |
|
|
|
| Secondary | Occurrence of Serious Adverse Events (SAEs) | Number of participants with Serious Adverse Events (SAEs) | Safety analysis set | Posted | Number | participants | First dose of investigational product to Study End at approximately 18 weeks of age |
|
|
|
| Secondary | 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 | Full analysis Set | Posted | Number | participants | First dose of Investigational product to Study End at approximately 18 weeks of age |
|
|
|
| 1 |
| 170 |
| 11 |
| 170 |
| 67 |
| 170 |
| EG001 | Mid Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration | 0 | 172 | 7 | 172 | 68 | 172 |
| EG002 | Low Dose RV3-BB Neonatal Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration | 2 | 169 | 8 | 169 | 69 | 169 |
| EG003 | High Dose RV3-BB Infant Schedule | 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) RV3-BB: Oral administration Placebo: Oral administration | 1 | 173 | 5 | 173 | 59 | 173 |
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sepsis Neonatal | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Breast Abscess | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Septic Shock | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Omphalitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Infantile Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
|
| Jaundice Neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA 20.0 | Systematic Assessment |
|
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Opthalmia Neonatorum | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Otitis Media | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Sepsis Neonatal | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
The Principal Investigator must not Publish or present any aspect of the Study without the prior written approval of the Sponsor such approval will not to be unreasonably withheld
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Shedding RV3-BB vaccine virus |
|
| RV3-BB Vaccine Shedding |
|
| Serum IgA |
|
| RV3-BB vaccine shedding |
|
| Serum IgA |
|
| RV3-BB vaccine shedding |
|