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| ID | Type | Description | Link |
|---|---|---|---|
| OPP1017334 | Other Grant/Funding Number | Bill and Melinda Gates Foundation |
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| Name | Class |
|---|---|
| Noguchi Memorial Institute for Medical Research | OTHER |
| Navrongo Health Research Centre, Ghana | OTHER |
| Centers for Disease Control and Prevention | FED |
The purpose of this study is to determine whether giving the Human Rotavirus Vaccine on alternate dosing schedules will enhance the immune response to the vaccine in a low-resource, high-burden country in Africa. Alternate dosing schedules studied include giving the 2-dose vaccine schedule at a slightly older age and giving an additional dose of the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rotavirus Vaccine at age 6 & 10 weeks | Active Comparator | Participants are provided with the Human Rotavirus Vaccine (HRV) at 6 & 10 weeks of age. |
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| Rotavirus vaccine at age 10 & 14 weeks | Experimental | Participants are provided with the Human Rotavirus Vaccine (HRV) at 10 & 14 weeks of age. |
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| Rotavirus vaccine at age 6,10,&14 weeks | Experimental | Participants are provided with the Human Rotavirus Vaccine (HRV) at 6, 10, & 14 weeks of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Rotavirus Vaccine | Biological | Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age, 10 & 14 weeks of age, or 6, 10, & 14 weeks of age, depending on study arm assignment. |
| Measure | Description | Time Frame |
|---|---|---|
| Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA). | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
| Measure | Description | Time Frame |
|---|---|---|
| IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules | Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA. | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Armah, PhD | Noguchi Memorial Institute for Medical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Navrongo Health Research Center | Navrongo | Upper East Region | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26823335 | Derived | Armah G, Lewis KD, Cortese MM, Parashar UD, Ansah A, Gazley L, Victor JC, McNeal MM, Binka F, Steele AD. A Randomized, Controlled Trial of the Impact of Alternative Dosing Schedules on the Immune Response to Human Rotavirus Vaccine in Rural Ghanaian Infants. J Infect Dis. 2016 Jun 1;213(11):1678-85. doi: 10.1093/infdis/jiw023. Epub 2016 Jan 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotavirus Vaccine at Age 6 & 10 Weeks | Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age. |
| FG001 | Rotavirus Vaccine at Age 10 & 14 Weeks | Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age. |
| FG002 | Rotavirus Vaccine at Age 6,10,&14 Weeks | Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled subjects who received at least one rotavirus vaccine dose and are IgA seronegative (< 20 U/mL) at 6 (Groups 1 and 3) or 10 (Group 2) weeks of age at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotavirus Vaccine at Age 6 & 10 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age. |
| BG001 | Rotavirus Vaccine at Age 10 & 14 Weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Immunoglobulin A (IgA) Seroconversion: 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre-vaccination as measured by Enzyme Immunoassay (EIA). | Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and oral polio vaccine (OPV) according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results. | Posted | Number | 95% Confidence Interval | percentage of participants | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
|
Adverse events: 1 month following each study vaccination; serious adverse events: throughout study period, up to 5 months
Any participant receiving one or more doses of rotavirus vaccine was included in this analysis.
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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 | Rotavirus Vaccine at Age 6 & 10 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Scientist | PATH | 206-285-3500 | klewis@path.org |
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| ID | Term |
|---|---|
| C492457 | RIX4414 vaccine |
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| IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison. | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
| IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule | IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison. | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
| Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination | The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution. | Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
| Vaccine-type Rotavirus Shedding in Stool | Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer's specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take. | Days 4 and 7 post each study vaccination |
| SAE Assessment | Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor. | Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Protocol Violation |
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Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
| BG002 | Rotavirus Vaccine at Age 6,10,&14 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age. |
| BG003 | Total | Total of all reporting groups |
| weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Rotavirus Vaccine at Age 6,10,&14 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age. |
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| Secondary | IgA Seroconversion: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedules | Anti-rotavirus IgA seroconversion will be defined as the detection of anti-rotavirus IgA antibodies at a concentration ≥20 U/mL post-vaccination in infants seronegative for anti-rotavirus IgA pre- vaccination as measured by EIA. | Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results. | Posted | Number | 95% Confidence Interval | percentage of participants | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
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| Secondary | IgA Geometric Mean Titers (GMTs): 6 & 10 Week vs. 6, 10, & 14 Week Vaccination Schedules | IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 6, 10, and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison. | Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results. | Posted | Geometric Mean | 95% Confidence Interval | titers | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
|
|
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| Secondary | IgA GMTs: 6 & 10 Week vs. 10 & 14 Week Vaccination Schedule | IgA GMTs measured by EIA will be compared post-vaccination between participants receiving Rotarix at 6 and 10 weeks of age and those receiving Rotarix at 10 and 14 weeks of age. For participants in Group 1, where post-vaccination response was measured at both 14 and 18 weeks of age, the highest response between these two visits was used as the final response for comparison. | Per-protocol analysis population--participants who (1) meet inclusion/exclusion criteria; (2) seronegative pre- vaccination; (3) concomitant administration of HRV and OPV according to Group schedule, (4) study visits in window periods (vaccination visits 4 weeks + 2 weeks), and (5) valid serology results. | Posted | Geometric Mean | 95% Confidence Interval | titers | 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
|
|
|
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| Secondary | Baseline Immunoglobulin G (IgG) Levels: Impact on IgA Seroconversion Post-vaccination | The number and percentage of participants demonstrating IgA seroconversion post-vaccination as defined above in infants seronegative for anti-rotavirus IgA pre- vaccination using the EIA assay) by EIA pre- and post-vaccination will be compared between participants in each group who had low as compared to high rotavirus immunoglobulin G (IgG) antibody levels pre-vaccination (i.e., at 6 weeks in Groups 1 and 3 and at 10 weeks in Group 2) as measured by Enzyme linked immunosorbent assay (ELISA). Low and high IgG categories will be determined based on the IgG antibody level distribution. | Not Posted | Baseline, 4-weeks post-vaccination (All Groups) and 8 weeks post-vaccination (6 & 10 week Group) |
| Secondary | Vaccine-type Rotavirus Shedding in Stool | Vaccine-type rotavirus shedding in the stool at 4 (±1 day) and 7 days (±1 day) following each Rotarix vaccination will be identified using EIA for rotavirus antigens and compared to baseline levels obtained just prior to each study vaccination. If shedding in stool is detected at either time point (per manufacturer's specifications) following each Rotarix vaccination, this will be considered evidence of vaccine take. | Not Posted | Days 4 and 7 post each study vaccination |
| Secondary | SAE Assessment | Serious adverse events (SAEs) occurring at anytime during the study will be measured as observed by study staff and/or reported by parent at any time. SAEs will be subcategorized according to treatment group as those deemed related to vaccination or not by an independent study monitor. | Not Posted | Throughout study period; Group 1: from enrollment through approximately 8 weeks of study participation, Groups 2 & 3: from enrollment through approximately 12 weeks of study participation |
| 1 |
| 152 |
| 78 |
| 152 |
| EG001 | Rotavirus Vaccine at Age 10 & 14 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age. | 4 | 152 | 76 | 152 |
| EG002 | Rotavirus Vaccine at Age 6,10,&14 Weeks | Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age. | 3 | 151 | 71 | 151 |
| Abscess of the Left Jaw | Infections and infestations | Systematic Assessment |
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| Acute Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Congenital Hydrocephalus | Congenital, familial and genetic disorders | Systematic Assessment |
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| Gluteal Abscess/ Sepsis | Infections and infestations | Systematic Assessment |
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| Infection/Abscess/Boil/Sepsis | Infections and infestations | Systematic Assessment |
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| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fever | Infections and infestations | Systematic Assessment |
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| Malaria | Infections and infestations | Systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | Systematic Assessment |
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| Irritable/refusing to feed | Infections and infestations | Systematic Assessment |
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