Trial Outcomes & Findings for Effectiveness of Monovalent Rotavirus Vaccine (RV1) (NCT NCT01871038)
NCT ID: NCT01871038
Last Updated: 2026-01-26
Results Overview
RV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 52 days of age. The recommend age for the first dose is 42 days, but children are considered vaccinated if they receive that dose within 4 days of the recommended age, which lowers the acceptable minimum age to 38 days. We added 14 days to enable them to mount an immune response to arrive at a minimum age of 52 days. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
COMPLETED
362 participants
14 days from the date of enrollment
2026-01-26
Participant Flow
Children less than 6 years of age with hospitalizations and emergency department (ED visits due to AGE between 1/1/2008-6/30/2012 were prospectively recruited to participate in the study at Cincinnati Children's Hospital Medical Center (CCHMC) and the Medical University of South Carolina (MUSC).
362 participants were enrolled in the overall study, which is stated in the protocol section. The participant totals in Models One and Two do not equal the overall number enrolled because some participants were included in both models.
Participant milestones
| Measure |
Vaccine Effectiveness Study Population - Rotavirus Positive Cases
Patients eligible for active surveillance based on the recruitment details and eligibility criteria who provided a stool specimen to be tested that had a positive stool sample.
|
Vaccine Effectiveness Study Population - Rotavirus Negative Controls
Patients eligible for active surveillance based on the recruitment details and eligibility criteria who provided a stool specimen to be tested that had a Negative stool sample.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
313
|
|
Overall Study
COMPLETED
|
49
|
313
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Monovalent Rotavirus Vaccine (RV1)
Baseline characteristics by cohort
| Measure |
Rotavirus Positive Cases
n=49 Participants
All stool specimens were tested for rotavirus. Participants with a positive test result are included in this category.
|
Rotavirus Negative Controls
n=313 Participants
All stool specimens were tested for rotavirus. Participants with a negative test result are included in this category.
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
49 Participants
n=41 Participants
|
313 Participants
n=1581 Participants
|
362 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
16.13 months
n=41 Participants
|
14.82 months
n=1581 Participants
|
14.83 months
n=4626 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
149 Participants
n=1581 Participants
|
167 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=41 Participants
|
164 Participants
n=1581 Participants
|
195 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=41 Participants
|
19 Participants
n=1581 Participants
|
21 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
47 Participants
n=41 Participants
|
293 Participants
n=1581 Participants
|
340 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=41 Participants
|
164 Participants
n=1581 Participants
|
188 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=41 Participants
|
110 Participants
n=1581 Participants
|
130 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
30 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
11 Participants
n=1581 Participants
|
12 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=41 Participants
|
313 participants
n=1581 Participants
|
362 participants
n=4626 Participants
|
|
Vaccination Status
Fully Vaccinated with Rotarix only
|
12 Participants
n=41 Participants
|
193 Participants
n=1581 Participants
|
205 Participants
n=4626 Participants
|
|
Vaccination Status
Partially Vaccinated with Rotarix only
|
6 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
37 Participants
n=4626 Participants
|
|
Vaccination Status
Not Vaccinated
|
31 Participants
n=41 Participants
|
89 Participants
n=1581 Participants
|
120 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 14 days from the date of enrollmentRV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 52 days of age. The recommend age for the first dose is 42 days, but children are considered vaccinated if they receive that dose within 4 days of the recommended age, which lowers the acceptable minimum age to 38 days. We added 14 days to enable them to mount an immune response to arrive at a minimum age of 52 days. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
Outcome measures
| Measure |
Minimum Age Model - Rotavirus Positive Cases
n=49 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested positive for rotavirus.
|
Minimum Age Model - Rotavirus Negative Controls
n=182 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested negative for rotavirus.
|
|---|---|---|
|
Matched VE Participants in the Minimum Age Model
1 Dose
|
6 Participants
|
31 Participants
|
|
Matched VE Participants in the Minimum Age Model
O Doses
|
31 Participants
|
70 Participants
|
|
Matched VE Participants in the Minimum Age Model
2 Doses
|
12 Participants
|
81 Participants
|
PRIMARY outcome
Timeframe: 14 days from the date of enrollmentRV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were age-eligible to receive at least the first dose of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.
Outcome measures
| Measure |
Minimum Age Model - Rotavirus Positive Cases
n=194 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested positive for rotavirus.
|
Minimum Age Model - Rotavirus Negative Controls
n=138 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested negative for rotavirus.
|
|---|---|---|
|
Vaccine Effectiveness of RV1 in the Minmum Age Model
|
69 percent probability
Interval 32.0 to 86.0
|
59 percent probability
Interval -13.0 to 85.0
|
PRIMARY outcome
Timeframe: 14 days from the date of enrollmentRV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were at least 8 months of age, the maximum recommend age for completion of 2 doses of RV1. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses.
Outcome measures
| Measure |
Minimum Age Model - Rotavirus Positive Cases
n=38 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested positive for rotavirus.
|
Minimum Age Model - Rotavirus Negative Controls
n=283 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested negative for rotavirus.
|
|---|---|---|
|
Matched VE Participants in the Maximum Age Model
2 Doses
|
11 Participants
|
171 Participants
|
|
Matched VE Participants in the Maximum Age Model
0 Doses
|
24 Participants
|
83 Participants
|
|
Matched VE Participants in the Maximum Age Model
1 Dose
|
3 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: 14 days from the date of enrollmentRV1 Vaccine Effectiveness (VE) was studied using a subset of the active surveillance participants who were greater than or equal to 8 months of age, the maximum recommended age for completion of two doses of RV1 vaccine. Only valid RV1 vaccinations were considered. We estimated RV1 VE of 2 doses vs 0 doses and 1 dose vs 0 doses. VE was estimated as (1 - exposure odds ratio) x 100.
Outcome measures
| Measure |
Minimum Age Model - Rotavirus Positive Cases
n=289 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested positive for rotavirus.
|
Minimum Age Model - Rotavirus Negative Controls
n=139 Participants
All stool samples were tested using Rotaclone, a commercially available immunoassay and this group contain those participants that tested negative for rotavirus.
|
|---|---|---|
|
Vaccine Effectiveness of RV1 in the Maximum Age Model
|
82 percentage probability
Interval 59.0 to 92.0
|
77 percentage probability
Interval 13.0 to 94.0
|
Adverse Events
Rotavirus Positive Cases
Rotavirus Negative Controls
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mary Allen Staat
Cincinnati Childrens Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place