A Phase 4 interventional study of Rotarix, dose 1 and Rotarix, dose 2 in Rotavirus Infection, Vaccine Response Impaired and Vaccine Virus Shedding, sponsored by University of Vermont. Completed at 1 site in Bangladesh. Open to participants aged Up to 15 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-04.
Sponsored by University of Vermont · Phase 4, Interventional, and Prevention
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.
101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 220 is below the median of 402 across 68 interventional studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →University of Vermont is the lead sponsor of 215 studies on the registry; 28 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Biological: Rotarix, dose 1 · Drug: Placebo (for Rotarix dose 2)
Rotarix 3 mL by mouth (two standard doses administered simultaneously) at both 6 and 10 weeks of life
Biological: Rotarix, dose 1 · Biological: Rotarix, dose 2
Rotarix, dose 1
Rotarix, dose 2
Sterile water to provide volume equivalent as a second dose of Rotarix
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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at week 14 of life
| Milestone | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| Started | 110 | 110 |
| Completed | 99 | 103 |
| Not completed | 11 | 7 |
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.
| Participants | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| Number (or Percentage) of Infants in Each Study Arm Who Test Positive for Fecal Rotavirus Vaccine-strain Virus Shedding Post-vaccination | 63 | 55 |
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.
| Participants | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| Number (or Percentage) of Infants in Each Study Arm With Rotavirus-specific Plasma Immunoglobulin A (IgA) Seroconversion Post-vaccination | 41 | 42 |
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.
| Participants | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| 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 | 69 | 62 |
Collected over 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). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rotarix, Single Dose | 0/110 (0%) | 2/110 (1.8%) | 28/107 (26.2%) |
| Rotarix, Double Dose | 0/110 (0%) | 4/110 (3.6%) | 31/106 (29.2%) |
| Event | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| DiarrheaGastrointestinal disorders | 1/110 | 2/110 |
| SepsisInfections and infestations | 1/110 | 0/110 |
| Subacute intestinal obstructionGastrointestinal disorders | 0/110 | 1/110 |
| Diaphragmatic herniaRespiratory, thoracic and mediastinal disorders | 0/110 | 1/110 |
| Event | Rotarix, Single Dose | Rotarix, Double Dose |
|---|---|---|
| Respiratory tract infectionInfections and infestations | 22/107 | 21/106 |
| Gastroenteritis (vomiting and/or diarrhea)Gastrointestinal disorders | 19/107 | 18/106 |
| Cough or runny noseRespiratory, thoracic and mediastinal disorders | 12/107 | 18/106 |
| DiarrheaGastrointestinal disorders | 18/107 | 16/106 |
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.
| Age, Categorical(Participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| <=18 years | 97 | 92 | 189 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(days) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Mean | 4.8 ± 1.8 | 5.0 ± 1.8 | 4.9 ± 1.8 |
| Sex: Female, Male(Participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Female | 51 | 41 | 92 |
| Male | 46 | 51 | 97 |
| Race and Ethnicity Not Collected(Participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Bangladesh | 97 | 92 | 189 |
| Birth place(Participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Home birth | 19 | 25 | 44 |
| Hospital/clinic birth | 78 | 67 | 145 |
| Mode of delivery(Participants) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Vaginal | 55 | 50 | 105 |
| Caesarean section | 42 | 42 | 84 |
| Weight(kg) | Rotarix, Single Dose | Rotarix, Double Dose | Total |
|---|---|---|---|
| Mean | 2.81 ± 0.44 | 2.86 ± 0.38 | 2.83 ± 0.42 |
6 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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