Trials / Completed
CompletedNCT01263327
Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine
An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Xiamen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HPV 16/18 | Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses. |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-07-01
- Completion
- 2011-07-01
- First posted
- 2010-12-20
- Last updated
- 2020-07-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01263327. Inclusion in this directory is not an endorsement.