Trial Outcomes & Findings for An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED) (NCT NCT00496626)
NCT ID: NCT00496626
Last Updated: 2017-04-17
Results Overview
Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array. The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) \<7, \<8, \<11, \<10 respectively)
COMPLETED
PHASE3
600 participants
Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7
2017-04-17
Participant Flow
Participant milestones
| Measure |
Vaccine (Gardasil®) Group
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
298
|
|
Overall Study
COMPLETED
|
296
|
292
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Vaccine (Gardasil®) Group
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Relocated
|
0
|
1
|
Baseline Characteristics
An Immunogenicity and Safety Study of Gardasil® in Chinese Subjects (V501-030)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Vaccine (Gardasil®) Group
n=302 Participants
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group
n=298 Participants
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
24.6 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Age, Customized
9-15 Years of Age
|
101 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Age, Customized
16-26 Years of Age
|
76 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Age, Customized
27-34 Years of Age
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Age, Customized
35-45 Years of Age
|
62 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
251 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Body Temperature
|
36.5 Degrees Celsius
STANDARD_DEVIATION 0.31 • n=5 Participants
|
36.5 Degrees Celsius
STANDARD_DEVIATION 0.31 • n=7 Participants
|
36.5 Degrees Celsius
STANDARD_DEVIATION 0.31 • n=5 Participants
|
|
Pulse
|
74.4 Beats per minute (BPM)
STANDARD_DEVIATION 11.9 • n=5 Participants
|
74.6 Beats per minute (BPM)
STANDARD_DEVIATION 11.2 • n=7 Participants
|
74.5 Beats per minute (BPM)
STANDARD_DEVIATION 11.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination, and Month 7Population: Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.
Measured GMT of anti-HPV 6, 11, 16 and 18 at Day 1 and Month 7 (1 month after completion of administration of a 6-month 3-dose regimen of vaccines). GMT at Day 1 was used to define per-protocol population. Antibody titers were tested with Luminex array. The numeric values for the Day 1 (Vaccine and Placebo groups) and the Month 7 (Placebo groups) are the threshold of detection for the Luminex array assays. The reported values are all below the lower limit of qualification, ((less than) \<7, \<8, \<11, \<10 respectively)
Outcome measures
| Measure |
Vaccine (Gardasil®) Group (Day 1)
n=302 Participants
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Day 1)
n=298 Participants
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Vaccine (Gardasil®) Group (Month 7)
n=302 Participants
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Month 7)
n=298 Participants
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)
anti-HPV 6
|
7 mMU/mL
Interval 7.0 to 7.0
|
7 mMU/mL
Interval 7.0 to 7.0
|
426.0 mMU/mL
Interval 369.5 to 491.0
|
7 mMU/mL
Interval 7.0 to 7.0
|
|
Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)
anti-HPV 11
|
8 mMU/mL
Interval 8.0 to 8.0
|
8 mMU/mL
Interval 8.0 to 8.0
|
665.0 mMU/mL
Interval 589.4 to 750.3
|
8 mMU/mL
Interval 8.0 to 8.0
|
|
Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)
anti-HPV 16
|
11 mMU/mL
Interval 11.0 to 11.0
|
11 mMU/mL
Interval 11.0 to 11.0
|
2336.9 mMU/mL
Interval 2023.1 to 2699.3
|
11 mMU/mL
Interval 11.0 to 11.0
|
|
Geometric Mean Titer (GMT) of Anti-HPV 6, 11, 16 , 18 at Day 1 and Month 7 (1 Month After Completion of Administration of a 6-month 3-dose Regimen of Vaccines)
anti-HPV 18
|
10 mMU/mL
Interval 10.0 to 10.0
|
10 mMU/mL
Interval 10.0 to 10.0
|
535.6 mMU/mL
Interval 461.8 to 621.2
|
10 mMU/mL
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: Collect blood sample for anti-HPV 6, 11, 16, 18 titers testing at Day 1 prior to vaccination and Month 7Population: Per-protocol population, defined as all participants who received all 3 dose vaccinations within acceptable day ranges, had at least 1 valid serology result after the third injection, and adhered to protocol guidelines. To be included in the immunogenicity analysis for given HPV type, participants must be seronegative to that HPV type at baseline.
Anti-HPV 6, 11, 16, 18 Seroconversion Rate, i.e., the Number of participants who were seronegative at baseline and developed seropositive at Month 7. Seroconversion for HPV 6, 11, 16, and 18 is defined as achieving an anti-HPV cLIA level of at least 20, 16, 20 and 24 mMU/mL, respectively. Seroconversion rate = (number of participants with seronegative at baseline and developed seropositive at Month 7)/(number of participants with seronegative at baseline regardless relevant HPV serum status at Month 7). Measure serum anti-HPV 6, 11, 16, 18 titers at Day 1 prior to vaccination and at Month 7
Outcome measures
| Measure |
Vaccine (Gardasil®) Group (Day 1)
n=302 Participants
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Day 1)
n=298 Participants
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Vaccine (Gardasil®) Group (Month 7)
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Month 7)
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|---|---|
|
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7
anti-HPV 6
|
269 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7
anti-HPV 11
|
279 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7
anti-HPV 16
|
277 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Who Were Seronegative at Baseline and Developed Seropositive at Month 7
anti-HPV 18
|
287 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccinationPopulation: Safety population, defined as all participants who were vaccinated at least one dose and had safety follow-up data
All adverse experiences were collected through 14 days following each vaccination. All participants were requested to record injection-site adverse experiences and monitor the participant's 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 each injection.
Outcome measures
| Measure |
Vaccine (Gardasil®) Group (Day 1)
n=302 Participants
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Day 1)
n=298 Participants
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Vaccine (Gardasil®) Group (Month 7)
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group (Month 7)
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|---|---|
|
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
|
153 Participants
|
131 Participants
|
—
|
—
|
Adverse Events
Vaccine (Gardasil®) Group
Placebo Group
Serious adverse events
| Measure |
Vaccine (Gardasil®) Group
n=302 participants at risk
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group
n=298 participants at risk
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|
|
Infections and infestations
Acute suppurative tonsillitis
|
0.00%
0/302
|
0.34%
1/298 • Number of events 1
|
Other adverse events
| Measure |
Vaccine (Gardasil®) Group
n=302 participants at risk
Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
Placebo Group
n=298 participants at risk
Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Injection site redness
|
0.99%
3/302 • Number of events 3
|
0.67%
2/298 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
20.2%
61/302 • Number of events 94
|
13.1%
39/298 • Number of events 46
|
|
Skin and subcutaneous tissue disorders
Injection site induration
|
2.0%
6/302 • Number of events 6
|
0.34%
1/298 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Injection site swelling
|
3.0%
9/302 • Number of events 9
|
0.67%
2/298 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Injection site pruritus
|
4.0%
12/302 • Number of events 16
|
0.67%
2/298 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.6%
11/302 • Number of events 16
|
4.0%
12/298 • Number of events 12
|
|
Nervous system disorders
Headache
|
5.3%
16/302 • Number of events 20
|
6.0%
18/298 • Number of events 20
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
9/302 • Number of events 11
|
3.4%
10/298 • Number of events 10
|
|
Gastrointestinal disorders
Nausea
|
2.6%
8/302 • Number of events 9
|
4.0%
12/298 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.6%
11/302 • Number of events 12
|
3.4%
10/298 • Number of events 16
|
|
Infections and infestations
Upper respiratory tract infection
|
6.0%
18/302 • Number of events 21
|
4.4%
13/298 • Number of events 14
|
|
General disorders
Allergic reaction
|
2.6%
8/302 • Number of events 9
|
0.67%
2/298 • Number of events 2
|
|
General disorders
Fatigue
|
5.6%
17/302 • Number of events 24
|
7.4%
22/298 • Number of events 25
|
|
General disorders
Fever
|
23.5%
71/302 • Number of events 83
|
23.5%
70/298 • Number of events 85
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
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