Trial Outcomes & Findings for Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients (NCT NCT01741012)
NCT ID: NCT01741012
Last Updated: 2018-11-05
Results Overview
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
37 participants
Primary outcome timeframe
1,61,66,181,186,211,330 days
Results posted on
2018-11-05
Participant Flow
Participant milestones
| Measure |
Gardasil
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Gardasil
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Study to Determine if Gardasil Vaccine is Safe and Effective in Lupus Patients
Baseline characteristics by cohort
| Measure |
Gardasil
n=34 Participants
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1,61,66,181,186,211,330 daysFrequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Outcome measures
| Measure |
Gardasil
n=34 Participants
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Frequency of Participants With Adverse Events
vaccine site reactions
|
21 Participants
|
|
Frequency of Participants With Adverse Events
non vaccine site reactions
|
33 Participants
|
PRIMARY outcome
Timeframe: 1,61,66,181,186,211,330 daysPopulation: Number of non vaccine adverse events
the number of non vaccine adverse events
Outcome measures
| Measure |
Gardasil
n=34 Participants
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Number of Non Vaccine Adverse Events
non vaccine adverse events
|
493 events
|
|
Number of Non Vaccine Adverse Events
serious adverse events
|
9 events
|
SECONDARY outcome
Timeframe: Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study.Population: The percentage of Human Papilloma Virus (HPV) naive women for HPV serotypes 6, 11, 16 and 18 that seroconverted
1\. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18
Outcome measures
| Measure |
Gardasil
n=34 Participants
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
HPV 6 Serotype
|
100 percentage of particpants
|
|
Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
HPV 11 Serotype
|
100 percentage of particpants
|
|
Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
HPV 16 Serotype
|
100 percentage of particpants
|
|
Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
HPV 18 Serotype
|
100 percentage of particpants
|
SECONDARY outcome
Timeframe: 1,61,66,181,186,211,330 daysPopulation: Number of patients who had a lupus flare defined by a SELENA -SLEDAI \> or = to 2
SELENA-SLEDAI measurements \> or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of \>2.
Outcome measures
| Measure |
Gardasil
n=34 Participants
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
SLE Disease Activity Flares
|
0 Participants
|
Adverse Events
Gardasil
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gardasil
n=34 participants at risk
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Chest pain and arm pain
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Pregnancy, puerperium and perinatal conditions
unplanned pregnancy
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Gastrointestinal disorders
nausea and vomiting with hypertensive crisis
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Musculoskeletal and connective tissue disorders
Chest pain and shortness of breath with left sided numbness
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Reproductive system and breast disorders
pain, swelling and discharge of the right breast
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Immune system disorders
shortness of breath and itching after eating peanut butter
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Musculoskeletal and connective tissue disorders
chest pain non cardiogenic
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Musculoskeletal and connective tissue disorders
swollen left leg with ulcer
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
Other adverse events
| Measure |
Gardasil
n=34 participants at risk
Single treatment arm:
0.5 ml single dose Gardasil vaccine given at three separate visits
Gardasil: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6 Total of 7 study visits with vaccines given at visits 2,4 and 6
|
|---|---|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
70.6%
24/34 • Number of events 106 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Nervous system disorders
nervouus system
|
73.5%
25/34 • Number of events 106 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
52.9%
18/34 • Number of events 49 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
General disorders
General disorders
|
50.0%
17/34 • Number of events 45 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Skin and subcutaneous tissue disorders
dermatologic
|
50.0%
17/34 • Number of events 45 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Infections and infestations
infections
|
61.8%
21/34 • Number of events 44 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder
|
35.3%
12/34 • Number of events 29 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Vascular disorders
vascular disorder
|
29.4%
10/34 • Number of events 18 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
20.6%
7/34 • Number of events 8 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Renal and urinary disorders
renal and urinary disorders
|
17.6%
6/34 • Number of events 6 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Reproductive system and breast disorders
reproductive system and breast disorders
|
17.6%
6/34 • Number of events 7 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Psychiatric disorders
psychiatric disorders
|
14.7%
5/34 • Number of events 12 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Immune system disorders
immune system disorders
|
11.8%
4/34 • Number of events 4 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Blood and lymphatic system disorders
Blood and Lymphatic system disorders
|
8.8%
3/34 • Number of events 3 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
8.8%
3/34 • Number of events 4 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Eye disorders
Eye disorders
|
8.8%
3/34 • Number of events 3 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Injury, poisoning and procedural complications
injury poisoning and procedural complications
|
8.8%
3/34 • Number of events 3 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Surgical and medical procedures
Surgical and medical procedures
|
8.8%
3/34 • Number of events 5 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Cardiac disorders
Cardiac disorders
|
5.9%
2/34 • Number of events 2 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasms benign, malignant and unspecified (incl dysts and polyps)
|
5.9%
2/34 • Number of events 2 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy , puerperium and perinatal conditions
|
5.9%
2/34 • Number of events 2 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
|
Hepatobiliary disorders
Hepatobiliary disorders-other
|
2.9%
1/34 • Number of events 1 • Data was collected for 18 months for each patient over the trial study period
Adverse events (AEs) were collected by: 1. 30 minute post vaccine unsolicited AEs--via 30 minute post vaccine AE recording sheet 2. 7 day post vaccine solicited AEs-- via 7 day memory aide recording sheet and reminder phone call 72 to 96 hours after each vaccination 3. 30 day post vaccine unsolicited AEs-- via 30 day diary and weekly phone calls. 4. weekly phone calls 5. once per month scripted phone calls
|
Additional Information
Dr. J. Patricia Dhar, MD, Principal Investigator
Wayne State University School of Medicine
Phone: 313-577-6011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place