Trial Outcomes & Findings for An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035) (NCT NCT00635830)
NCT ID: NCT00635830
Last Updated: 2015-10-09
Results Overview
All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination
Results posted on
2015-10-09
Participant Flow
Participant milestones
| Measure |
18 to 26 Years of Age Group
18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
9 to 17 Years of Age Group
9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
Baseline characteristics by cohort
| Measure |
18 to 26 Years of Age Group
n=20 Participants
18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
9 to 17 Years of Age Group
n=20 Participants
9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.64 years
STANDARD_DEVIATION 2.39 • n=5 Participants
|
13.82 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
18.73 years
STANDARD_DEVIATION 5.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Temperature
|
36.64 Degrees Celsius
STANDARD_DEVIATION 0.35 • n=5 Participants
|
36.35 Degrees Celsius
STANDARD_DEVIATION 0.24 • n=7 Participants
|
36.49 Degrees Celsius
STANDARD_DEVIATION 0.33 • n=5 Participants
|
|
Pulse
|
71.75 Beats per minute (BPM)
STANDARD_DEVIATION 4.17 • n=5 Participants
|
65.40 Beats per minute (BPM)
STANDARD_DEVIATION 2.68 • n=7 Participants
|
68.58 Beats per minute (BPM)
STANDARD_DEVIATION 4.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccinationAll adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Outcome measures
| Measure |
18 to 26 Years of Age Group
n=20 Participants
18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
9 to 17 Years of Age Group
n=20 Participants
9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
|---|---|---|
|
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
Serious Adverse Experiences
|
0 Participants
|
0 Participants
|
|
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
Systemic Adverse Experiences
|
7 Participants
|
10 Participants
|
|
Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination
Injection-Site Complaints
|
4 Participants
|
7 Participants
|
Adverse Events
18 to 26 Years of Age Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
9 to 17 Years of Age Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
18 to 26 Years of Age Group
n=20 participants at risk
18 to 26 years of age group was enrolled to evaluate safety firstly.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
9 to 17 Years of Age Group
n=20 participants at risk
9 to 17 years of age group was enrolled after the Ethics Review Committee approval of the older group safety data.
Subjects in this group received one 0.5-ml intramuscular injection of Quadrivalent HPV L1 VLP vaccine.
|
|---|---|---|
|
General disorders
Injection site painness
|
20.0%
4/20 • Number of events 4
|
35.0%
7/20 • Number of events 7
|
|
Nervous system disorders
Headache
|
0.00%
0/20
|
15.0%
3/20 • Number of events 3
|
|
Eye disorders
Conjunctivitis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/20
|
15.0%
3/20 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
0.00%
0/20
|
10.0%
2/20 • Number of events 2
|
|
Reproductive system and breast disorders
Menstrual disorder
|
5.0%
1/20 • Number of events 1
|
0.00%
0/20
|
|
General disorders
Allergic reaction
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fever
|
15.0%
3/20 • Number of events 3
|
15.0%
3/20 • Number of events 3
|
|
General disorders
Muscle pain
|
0.00%
0/20
|
15.0%
3/20 • Number of events 3
|
|
General disorders
Fatigue
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
|
General disorders
Hypodynamia
|
5.0%
1/20 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER