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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Charles H. Hood Foundation | OTHER |
| Thrasher Research Fund | OTHER |
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Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh.
Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotarix, single dose | Active Comparator | Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life |
|
| Rotarix, double dose | Experimental | Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotarix, dose 1 | Biological | Rotarix, dose 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination | This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding. | Measured through week 12 of life |
| Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination | This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration <=20 U/mL pre-vaccination and >20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure. | Measured at week 14 of life |
| Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination | Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take. | Measured at week 14 of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Lee, M.D. | University of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Center for Diarrhoeal Disease Research, Bangladesh (icddr,b) | Dhaka | Bangladesh |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31607603 | Derived | Lee B, Dickson DM, Alam M, Afreen S, Kader A, Afrin F, Ferdousi T, Damon CF, Gullickson SK, McNeal MM, Bak DM, Tolba M, Carmolli MP, Taniuchi M, Haque R, Kirkpatrick BD. The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial. Vaccine. 2020 Jan 3;38(1):90-99. doi: 10.1016/j.vaccine.2019.09.088. Epub 2019 Oct 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotarix, Single Dose | Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix |
| FG001 | Rotarix, Double Dose | Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Rotarix, dose 2: Rotarix, dose 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The a priori primary analysis was designed to evaluate study outcomes among those who completed the study per-protocol. Due to anticipated levels of attrition, the per-protocol population differs from the total numbers of initial enrollees. Data presented are for the per protocol population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotarix, Single Dose | Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix |
| 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 (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination | This will be an aggregate measure demonstrating a change from baseline. Infants will have stool collected immediately prior to Rotarix vaccination at weeks 6 and 10 of life, then 4, 7, and 14 days following each dose (i.e. last assessment at week 12 of life). Each specimen will be assessed for vaccine-strain virus (i.e. fecal vaccine shedding) at each time point by polymerase chain reaction. Any child who has a change in fecal vaccine shedding status, from negative at baseline (6 weeks) to positive at any subsequent time point, will be categorized as having met the outcome measure for positive fecal vaccine shedding. | Posted | Count of Participants | Participants | Measured through week 12 of life |
|
Enrollment (<7 days of life) through week 14 study visit (4 months) for serious adverse events; week 6 visit (first vaccine dose) through Week 14 visit + 3 days (end of participation) for all other AEs (2 months)
Serious adverse events were recorded from study enrollment (<7 days of life) but all other adverse events were only recorded starting from the first study intervention (at the week 6 clinic visit), the total numbers of children evaluated for serious adverse events (which is based on study enrollment) differs from those evaluated for adverse events (which is based on the number of children dosed starting at week 6 of life, and is less due to attrition between enrollment and first dosing).
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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 | Rotarix, Single Dose | Rotarix 1.5 mL (standard single dose) and 1.5 mL of placebo by mouth (sterile, pharmacy-grade water) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Placebo (for Rotarix dose 2): Sterile water to provide volume equivalent as a second dose of Rotarix |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Lee | The University of Vermont College of Medicine | 8026567748 | blee7@uvm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2019 | Jun 30, 2020 | Prot_SAP_000.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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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
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| Rotarix, dose 2 |
| Biological |
Rotarix, dose 2 |
|
| Placebo (for Rotarix dose 2) | Drug | Sterile water to provide volume equivalent as a second dose of Rotarix |
|
| Rotarix, Double Dose |
Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Rotarix, dose 2: Rotarix, dose 2 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Birth place | Count of Participants | Participants |
|
| Mode of delivery | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Length | Mean | Standard Deviation | cm |
|
| Head circumference | Mean | Standard Deviation | cm |
|
| Water treatment | Count of Participants | Participants |
|
| Type of toilet | Count of Participants | Participants |
|
| Family demographics | Count of Participants | Participants |
|
| Monthly household income in Taka | Median | Inter-Quartile Range | Taka |
|
| OG001 | Rotarix, Double Dose | Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Rotarix, dose 2: Rotarix, dose 2 |
|
|
| Primary | Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination | This outcome will measure seroconversion, i.e. the change in plasma rotavirus-specific IgA concentration at week 14 of life compared to week 6 of life (baseline). Blood will be collected from infants prior to the first dose of Rotarix at week 6 of life and again at week 14 of life (4 weeks following the second dose) for measurement of plasma rotavirus-specific IgA by enzyme immunoassay. Infants will be assessed for seroconversion (IgA concentration <=20 U/mL pre-vaccination and >20 post-vaccination). Infants who demonstrate rotavirus-specific IgA seroconversion will be categorized as having met the outcome measure. | Posted | Count of Participants | Participants | Measured at week 14 of life |
|
|
|
| Primary | Number (or Percentage) of Infants in Each Study Arm With Successful Vaccine Take, Defined as Positive Fecal Vaccine Shedding Post-vaccination OR Rotavirus-specific Plasma IgA Seroconversion Post-vaccination | Vaccine take is an aggregate, dichotomous immunogenicity measure (successful vaccine take vs no vaccine take). Infants positive for either fecal vaccine shedding OR plasma rotavirus-specific IgA seroconversion (as described in Outcomes 1 and 2, respectively) will be categorized as having met the outcome measure of successful vaccine take. Those who met neither outcome will be categorized as no vaccine take. | Posted | Count of Participants | Participants | Measured at week 14 of life |
|
|
|
| 0 |
| 110 |
| 2 |
| 110 |
| 28 |
| 107 |
| EG001 | Rotarix, Double Dose | Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life Rotarix, dose 1: Rotarix, dose 1 Rotarix, dose 2: Rotarix, dose 2 | 0 | 110 | 4 | 110 | 31 | 106 |
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Subacute intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diaphragmatic hernia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough or runny nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastroenteritis (vomiting and/or diarrhea) | Gastrointestinal disorders | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
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