Trial Outcomes & Findings for Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy (NCT NCT00727636)
NCT ID: NCT00727636
Last Updated: 2011-05-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
Month 7
Results posted on
2011-05-27
Participant Flow
Location - Children's Hospital Boston, including Waltham Infusion Center, and Maine Medical Center. Patients were recruited during a scheduled clinical or Remicade infusion visit, a hospital admission, by contact through mail followed by a phone call, or through referral from local hospitals. Recruitment period -April 2008 through April 2010
Participant milestones
| Measure |
Prospective Cohort
Received Gardasil as part of study
|
Retrospective Cohort
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
15
|
|
Overall Study
COMPLETED
|
33
|
15
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity to Human Papillomavirus Vaccine (Gardasil) Among IBD Patients on Immunosuppressive Therapy
Baseline characteristics by cohort
| Measure |
Prospective Cohort
n=37 Participants
Received Gardasil as part of study
|
Retrospective Cohort
n=15 Participants
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
14.9 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
18.9 years
STANDARD_DEVIATION 3.5 • n=7 Participants
|
16.1 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
15 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 7Outcome measures
| Measure |
Prospective Cohort
n=33 Participants
Received Gardasil as part of study
|
Retrospective Cohort
n=15 Participants
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Antibody Titer to HPV 6
|
1079.9 milli-Merck units/mL
Interval 783.0 to 1489.3
|
173.4 milli-Merck units/mL
Interval 91.3 to 329.5
|
PRIMARY outcome
Timeframe: Month 7Population: Number of participants who completed all vaccine doses
Outcome measures
| Measure |
Prospective Cohort
n=33 Participants
Received Gardasil as part of study
|
Retrospective Cohort
n=15 Participants
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Antibody Titer to HPV 11
|
1681.8 milli-Merck units/mL
Interval 1189.9 to 2377.2
|
267.3 milli-Merck units/mL
Interval 122.4 to 583.8
|
PRIMARY outcome
Timeframe: Month 7Geometric mean titer (95% CI)
Outcome measures
| Measure |
Prospective Cohort
n=33 Participants
Received Gardasil as part of study
|
Retrospective Cohort
n=15 Participants
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Antibody Titers to HPV 16
|
3975.1 milli-Merck units/mL
Interval 2492.2 to 6340.6
|
802.7 milli-Merck units/mL
Interval 391.1 to 1676.6
|
PRIMARY outcome
Timeframe: Month 7Geometric mean titer (95%CI)
Outcome measures
| Measure |
Prospective Cohort
n=33 Participants
Received Gardasil as part of study
|
Retrospective Cohort
n=15 Participants
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Antibody Titer to HPV 18
|
857.6 milli-Merck units/mL
Interval 472.4 to 1556.6
|
79.5 milli-Merck units/mL
Interval 26.3 to 240.5
|
Adverse Events
Prospective Cohort
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
Retrospective Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prospective Cohort
n=37 participants at risk
Received Gardasil as part of study
|
Retrospective Cohort
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Gastrointestinal disorders
Admitted to hospital
|
5.4%
2/37 • Number of events 2 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Admitted to hospital
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Reproductive system and breast disorders
Admitted to hospital
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Went to emergency department
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
Other adverse events
| Measure |
Prospective Cohort
n=37 participants at risk
Received Gardasil as part of study
|
Retrospective Cohort
Patients received Gardasil vaccine from their primary medical provider. They had blood drawn for the study after they completed the vaccine
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
leg pain
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma related symptoms
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Gastrointestinal disorders
Rectal bleeding and diarrhea
|
5.4%
2/37 • Number of events 2 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
General disorders
Axillary abscess
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
Skin and subcutaneous tissue disorders
Rash on their chin
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
General disorders
Abdominal pain
|
8.1%
3/37 • Number of events 3 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
General disorders
Migraine
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
|
General disorders
Swelling and severe pain in arm
|
2.7%
1/37 • Number of events 1 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
—
0/0 • From the 1st dose of vaccine until 1 month after the 3rd dose of vaccine
Adverse events were only evaluated in the Prospective Study patients. The Retrospective Study patients were not given the vaccine as part of this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60