Phase 1
N=40
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
HPV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00635830 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2009
Primary outcome: 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 — 0; 0; 7; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
0; 0; 7; 10; 4; 7 | — |
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.
Eligibility Criteria
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])
Data sourced from ClinicalTrials.gov (NCT00635830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.