Trials / Completed
CompletedNCT05426148
Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female
A Study to Assess the Immunogenicity Consistency of Three Consecutive Batches of Commercial-scale of Recombinant Human Papillomavirus(HPV) Bivalent Vaccine (Escherichia Coli) in Healthy Female Subjects Aged 9-14 Years
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 540 (actual)
- Sponsor
- Xiamen Innovax Biotech Co., Ltd · Industry
- Sex
- Female
- Age
- 9 Years – 14 Years
- Healthy volunteers
- Accepted
Summary
This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) .
Detailed description
This study is a mono-center, randomization, double-blind clinical trial in healthy Female subjects between 9 to 14. Under the premise of full informed consent, 540 subjects that meet the requirement of clinical trial in the age of 9-14 will be randomly divided into 3 groups in a ratio of 1:1:1 and injected 2 consecutive batches of Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) Cecolin® separately. The main outcome measures are the immunogenicity consistency and safety surveillance after inoculation according to prescribed immunization procedure.The total number of subjects should be ≥540 and ≤570.
Conditions
- Cervical Intraepithelial Neoplasia
- Cervical Cancer
- Vaginal Intraepithelial Neoplasia
- Vulvar Intraepithelial Neoplasia
- Persistent Infection
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin® | The bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant. |
Timeline
- Start date
- 2020-05-01
- Primary completion
- 2020-08-01
- Completion
- 2021-04-30
- First posted
- 2022-06-21
- Last updated
- 2022-06-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05426148. Inclusion in this directory is not an endorsement.