Trial Outcomes & Findings for Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study (NCT NCT02542462)
NCT ID: NCT02542462
Last Updated: 2018-07-12
Results Overview
Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
144 participants
Primary outcome timeframe
4- 6 days
Results posted on
2018-07-12
Participant Flow
During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement
43 of 144 enrolled participants withdrew prior to randomization
Participant milestones
| Measure |
Rotarix® Alone
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
25
|
26
|
|
Overall Study
COMPLETED
|
25
|
25
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
Baseline characteristics by cohort
| Measure |
Rotarix® Alone
n=25 Participants
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
n=25 Participants
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
n=25 Participants
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
n=26 Participants
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
8.5 weeks
n=5 Participants
|
8 weeks
n=7 Participants
|
8.2 weeks
n=5 Participants
|
8.4 weeks
n=4 Participants
|
8.2 weeks
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
101 Participants
n=21 Participants
|
|
Gestational age at birth (weeks)
|
38.6 weeks
n=5 Participants
|
38.8 weeks
n=7 Participants
|
38.9 weeks
n=5 Participants
|
38.8 weeks
n=4 Participants
|
38.8 weeks
n=21 Participants
|
|
Birthweight
|
3 kilograms
n=5 Participants
|
3 kilograms
n=7 Participants
|
3 kilograms
n=5 Participants
|
3 kilograms
n=4 Participants
|
3 kilograms
n=21 Participants
|
PRIMARY outcome
Timeframe: 4- 6 daysPopulation: Subjects had an abdominal MRI followed by an abdominal ultrasound prior to receiving vaccines at Day 0 (Visit 1). They returned 4-6 days later for follow up MRI and Ultrasound post vaccination (Visit 2) Terminal ileum thickness was measured and compared pre-post. Abdominal lymph nodes seen on ultrasound were compared pre-post
Number of subjects with an increase in the number of abdominal lymph nodes, as measured by abdominal ultrasound, or an increase of 1 mm or more of terminal ileum wall thickness, as measured by abdominal MRI, from Day 0 (Visit 1) to Day 4-6 (Visit 2)
Outcome measures
| Measure |
Rotarix® Alone
n=25 Participants
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
n=25 Participants
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
n=25 Participants
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
n=25 Participants
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
|---|---|---|---|---|
|
The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy
Terminal Ileum increase
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Effects of RV1 and RV5 With or Without Other Routine Immunizations on Gastrointestinal Anatomy
Lymph node increase
|
11 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: During the study period, there were 252 children screened and of these, 238 were eligible for enrollment. These subjects were identified through screening at a primary care clinic and through advertisement.
Study will be determined to be feasible on a larger scale if 10% or more of eligible subjects enroll in the study
Outcome measures
| Measure |
Rotarix® Alone
n=238 Participants
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
|---|---|---|---|---|
|
The Feasibility of Conducting a Larger Scale Study as Determined by Study Recruitment Rates (Number of Participants Eligible/Participants Who Enrolled)
|
144 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: All randomized subjects, irrespective of arm assignment
Study will be determined to be feasible on a larger scale if 70% or more of randomized subjects complete all study visits and remain in the study until completion
Outcome measures
| Measure |
Rotarix® Alone
n=101 Participants
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
|---|---|---|---|---|
|
The Feasibility of Conducting a Larger Scale Study as Determined by the Percentage of Participants Who Completed All Study Visits
|
100 Participants
|
—
|
—
|
—
|
Adverse Events
Rotarix® Alone
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Rotarix®,With Other Routine Vaccines
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
RotaTeq®, Alone
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
RotaTeq®,With Other Routine Vaccines
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Rotarix® Alone
n=25 participants at risk
monovalent rotavirus vaccine (Rotarix®, RV1)
Rotarix®,: Single oral dose of licensed rotavirus vaccine given alone
|
Rotarix®,With Other Routine Vaccines
n=25 participants at risk
monovalent rotavirus vaccine (Rotarix®, RV1), plus additional immunizations
Rotarix®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
RotaTeq®, Alone
n=25 participants at risk
pentavalent rotavirus vaccine (RotaTeq®, RV5)
RotaTeq®,: Single oral dose of licensed rotavirus vaccine given alone
|
RotaTeq®,With Other Routine Vaccines
n=26 participants at risk
pentavalent rotavirus vaccine (RotaTeq®,RV5) plus additional immunizations
RotaTeq®, with other routine vaccines: Single oral dose of licensed rotavirus vaccine given with other routine vaccines
|
|---|---|---|---|---|
|
Infections and infestations
Fever
|
16.0%
4/25 • Number of events 4 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
4.0%
1/25 • Number of events 1 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
24.0%
6/25 • Number of events 6 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
3.8%
1/26 • Number of events 1 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 3 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
12.0%
3/25 • Number of events 3 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
12.0%
3/25 • Number of events 3 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
7.7%
2/26 • Number of events 2 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
|
Gastrointestinal disorders
Vomiting
|
32.0%
8/25 • Number of events 8 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
28.0%
7/25 • Number of events 7 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
20.0%
5/25 • Number of events 5 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
30.8%
8/26 • Number of events 8 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
|
Nervous system disorders
Irritability
|
68.0%
17/25 • Number of events 17 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
60.0%
15/25 • Number of events 15 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
52.0%
13/25 • Number of events 13 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
61.5%
16/26 • Number of events 16 • 15 days
solicited adverse events included fever, diarrhea, vomiting, irritability and hematochezia. Parents of infants filled out a memory aid for 15 days recording any of these events.
|
Additional Information
Nancy Back RN MPH
Cincinnati Childrens Hospital Medical Center
Phone: 513-636-2479
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place