Cervical Cancer, Cervical Intraepithelial Neoplasia, Persistent Infection, Vaginal Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia
Conditions
Keywords
Human Papillomavirus Infection, Bivalent HPV Vaccine, Immunogenicity
Brief 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.
Interventions
BIOLOGICALRecombinant 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.
Sponsors
Jiangsu Province Centers for Disease Control and Prevention
Dongtai City Centers for Disease Control and Prevention
Xiamen Innovax Biotech Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Aged over 9 years old to 14 years old Female at the time of the first vaccine injection; * 2\. Statutory guardian of the subjects able to provide legal identification or the trustee able to provide the authorization certificate; * 3\. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations; * 4.Axillary temperature is below than 37.0 ℃; * 5.Negative for urine pregnancy test. * 6.The statutory guardian and trustee able to understand this study information and willing to comply with all study requirements(the statutory guardian or subject able to fill in the diary card and attend the follow-up on schedule). * 7.Willing to participate in this study and sign informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Geometric Mean concentration (GMC) of anti-HPV16/18 IgG at at one month after the 2nd dose. | 7 months | Measure anti-HPV16/18 IgG in serum samples at 7 month to evaluate the immunogenicity of the HPV vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure solicited local adverse reactions within 7 days after each vaccination. | 7 days | — |
| Measure solicited systematic adverse reactions within 7 days after each vaccination. | 7 days | — |
| Seroconversion rate of anti-HPV16/18 IgG at one month after the 2nd dose. | 7 months | Describe seroconversion rate of anti-HPV16/18 IgG one month after the last dose. |
| Measure serious adverse events occurred throughout the study. | up to 7 months | — |
| Measure Potential Immune Mediated Diseases occurred throughout the study. | up to 7 months | The Potential Immune Mediated Diseases refers to a disease of immune hyperfunction or immune deficiency caused by immune regulation disorder due to insufficient transmission of certain immune mediates, such as Guillain-Barre syndrome and thrombocytopenic purpura. |
| Measure unsolicited adverse reactions within 30 days after vaccination. | 30 days | — |
Countries
China
Outcome results
None listed