HPV Infections
Conditions
Brief summary
To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.
Interventions
HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 26 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment * Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent * Subject Is Able To Read, Understand, And Complete The Vaccination Report Card
Exclusion criteria
* Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use * Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention * Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed \[Used To Remove Residual Nucleic Acids From This And Other Vaccines\])
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | 9 to 17 Years of Age Group | Total | 18 to 26 Years of Age Group |
|---|---|---|---|
| Age, Continuous | 13.82 years STANDARD_DEVIATION 9.6 | 18.73 years STANDARD_DEVIATION 5.45 | 23.64 years STANDARD_DEVIATION 2.39 |
| Body Temperature | 36.35 Degrees Celsius STANDARD_DEVIATION 0.24 | 36.49 Degrees Celsius STANDARD_DEVIATION 0.33 | 36.64 Degrees Celsius STANDARD_DEVIATION 0.35 |
| Pulse | 65.40 Beats per minute (BPM) STANDARD_DEVIATION 2.68 | 68.58 Beats per minute (BPM) STANDARD_DEVIATION 4.72 | 71.75 Beats per minute (BPM) STANDARD_DEVIATION 4.17 |
| Sex: Female, Male Female | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / — | 11 / — |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
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
Time frame: 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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 18 to 26 Years of Age Group | 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 |
| 18 to 26 Years of Age Group | 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 |
| 18 to 26 Years of Age Group | 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 |
| 9 to 17 Years of Age Group | 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 |
| 9 to 17 Years of Age Group | 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 | 10 Participants |
| 9 to 17 Years of Age Group | 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 | 7 Participants |