A Phase 1 interventional study of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine in HPV Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to female participants aged 9 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-09.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Prevention
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.
495 studies on the registry are indexed under Papillomavirus Infections; 125 are open to participants now.
This study's enrollment of 40 is below the median of 202 across 332 interventional studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Open Label
Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
Also known as: V501
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
| Milestone | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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
| Participants | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group |
|---|---|---|
| Serious Adverse Experiences | 0 | 0 |
| Systemic Adverse Experiences | 7 | 10 |
| Injection-Site Complaints | 4 | 7 |
Non-serious events are listed at a 2.5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 18 to 26 Years of Age Group | — | 0/20 (0%) | — |
| 9 to 17 Years of Age Group | — | 0/20 (0%) | — |
| Event | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group |
|---|---|---|
| Injection site painnessGeneral disorders | 4/20 | 7/20 |
| HeadacheNervous system disorders | 0/20 | 3/20 |
| CoughingRespiratory, thoracic and mediastinal disorders | 0/20 | 3/20 |
| FeverGeneral disorders | 3/20 | 3/20 |
| Muscle painGeneral disorders | 0/20 | 3/20 |
| Upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 0/20 | 2/20 |
| FatigueGeneral disorders | 1/20 | 2/20 |
| HypodynamiaGeneral disorders | 1/20 | 2/20 |
| ConjunctivitisEye disorders | 1/20 | 0/20 |
| NauseaGastrointestinal disorders | 0/20 | 1/20 |
| Age, Continuous(years) | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group | Total |
|---|---|---|---|
| Mean | 23.64 ± 2.39 | 13.82 ± 9.6 | 18.73 ± 5.45 |
| Sex: Female, Male(Participants) | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 0 | 0 | 0 |
| Body Temperature(Degrees Celsius) | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group | Total |
|---|---|---|---|
| Mean | 36.64 ± 0.35 | 36.35 ± 0.24 | 36.49 ± 0.33 |
| Pulse(Beats per minute (BPM)) | 18 to 26 Years of Age Group | 9 to 17 Years of Age Group | Total |
|---|---|---|---|
| Mean | 71.75 ± 4.17 | 65.40 ± 2.68 | 68.58 ± 4.72 |
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC