Trial Outcomes & Findings for Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome (NCT NCT00767364)
NCT ID: NCT00767364
Last Updated: 2014-06-13
Results Overview
Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
12 months from the first vaccination date
Results posted on
2014-06-13
Participant Flow
Participant milestones
| Measure |
Infants With Bowel Resection
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome
Baseline characteristics by cohort
| Measure |
Infants With Bowel Resection
n=5 Participants
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
n=3 Participants
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Gestational Age
|
31.2 weeks
n=99 Participants
|
38.6 weeks
n=107 Participants
|
34.9 weeks
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
3 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Pre-vaccination serum IgA antirotavirus titer
Subject 1
|
1.56 U/ml
n=99 Participants
|
1.56 U/ml
n=107 Participants
|
3.12 U/ml
n=206 Participants
|
|
Pre-vaccination serum IgA antirotavirus titer
Subject 2
|
1.56 U/ml
n=99 Participants
|
1.56 U/ml
n=107 Participants
|
3.12 U/ml
n=206 Participants
|
|
Pre-vaccination serum IgA antirotavirus titer
Subject 3
|
1.56 U/ml
n=99 Participants
|
1.56 U/ml
n=107 Participants
|
3.12 U/ml
n=206 Participants
|
|
Pre-vaccination serum IgA antirotavirus titer
Subject 4
|
1.56 U/ml
n=99 Participants
|
NA U/ml
n=107 Participants
|
NA U/ml
n=206 Participants
|
|
Pre-vaccination serum IgA antirotavirus titer
Subject 5
|
1.56 U/ml
n=99 Participants
|
NA U/ml
n=107 Participants
|
NA U/ml
n=206 Participants
|
|
Rotavirus Anti-Immunoglobulin A (IgA) serum antibody level
|
618.61 U/ml
n=99 Participants
|
431.02 U/ml
n=107 Participants
|
540 U/ml
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 months from the first vaccination dateAdverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.
Outcome measures
| Measure |
Infants With Bowel Resection
n=5 Participants
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
n=3 Participants
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
|---|---|---|
|
Safety and Tolerability of the Oral RotaTeq® Vaccine
|
18 Individual Adverse Events
|
3 Individual Adverse Events
|
SECONDARY outcome
Timeframe: 6 months from the first vaccination dateSerum anti-rotavirus IgA level was measured post-vaccination in all subjects
Outcome measures
| Measure |
Infants With Bowel Resection
n=5 Participants
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
n=3 Participants
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
|---|---|---|
|
Serum Anti-rotavirus IgA Level Post-vaccination
Participant 1
|
916.4 U/ml
Interval 260.0 to 1018.0
|
935.6 U/ml
Interval 272.0 to 935.0
|
|
Serum Anti-rotavirus IgA Level Post-vaccination
Participant 2
|
679.5 U/ml
|
314.1 U/ml
|
|
Serum Anti-rotavirus IgA Level Post-vaccination
Participant 3
|
259.7 U/ml
|
272.5 U/ml
|
|
Serum Anti-rotavirus IgA Level Post-vaccination
Participant 4
|
1018.8 U/ml
|
NA U/ml
There was no available control subject for study participant 4
|
|
Serum Anti-rotavirus IgA Level Post-vaccination
Participant 5
|
550.0 U/ml
|
NA U/ml
There was no available control subject for study participant 5
|
Adverse Events
Infants With Bowel Resection
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Healthy Infants
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infants With Bowel Resection
n=5 participants at risk
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
n=3 participants at risk
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
|---|---|---|
|
Blood and lymphatic system disorders
Low hemoglobin
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Hepatobiliary disorders
Elevated Bilirubin level
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Infections and infestations
Fever, Rule out catheter infection
|
40.0%
2/5 • Number of events 3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Infections and infestations
Central Line Sepsis
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Bowel obstruction; Hirschsprung enterocolitis
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
Other adverse events
| Measure |
Infants With Bowel Resection
n=5 participants at risk
Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
Healthy Infants
n=3 participants at risk
Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series
|
|---|---|---|
|
Gastrointestinal disorders
Gastrostomy tube drainage after removal
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Stomal bleeding - hematochezia
|
40.0%
2/5 • Number of events 2 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Hematochezia
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Loose Stools
|
0.00%
0/5 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
33.3%
1/3 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Gastrointestinal disorders
Vomiting with diarrhea
|
40.0%
2/5 • Number of events 2 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
33.3%
1/3 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
General disorders
Fussiness
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
33.3%
1/3 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
|
Respiratory, thoracic and mediastinal disorders
Fever with upper respiratory infection
|
20.0%
1/5 • Number of events 1 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
0.00%
0/3 • 1 year (12 months) from receipt of the first dose of vaccine.
Participant parents were required to keep a symptoms diary and take their son/daughter temperature daily for the first week. Afterwards, the parent was required only to write any symptoms for 42 days on the same paper after each dose. Month phone call follow ups were made to assure that there were no other Adverse Events (AE)s x 12 months.
|
Additional Information
Eric McGrath, MD
Wayne State University School of Medicine, Children's Hospital of Michigan
Phone: 313-745-5863
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place