- Solid Tumors
- Pipeline Molecules
- Alliance Partners
Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03935204
Recruitment Status Active, not recruiting
First Posted May 2, 2019
Last update posted July 10, 2020
This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.
|Experimental: HPV Vaccine,270μg/1.0ml
Participants in this arm would receive 270μg/1.0ml HPV vaccines.
Biological: HPV Vaccine,270μg/1.0ml
HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
|Placebo Comparator: Placebo
Participants in this arm would receive 1.0ml aluminium adjuvant.
Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Health women aged between 18 and 45 years.
2. Judged as healthy and eligible for vaccination by the investigators through a
self-reported medical history and some physical examinations.
3. Able to comply with the requests of the study.
4. Written informed consent obtained from the participants.
5. Axillary temperature not higher than 37.0°C
6. Non-pregnant women verified by a urine pregnancy test.
1. Pregnant or breastfeeding or plan to be pregnant within 7 months.
2. Use of any investigational product or non-registered product (drug or vaccine) within
30 days preceding the first dose of the study vaccine or plan to use during the study
3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy
for more than 14 days in the 6 months before entry, except local treatment.
4. Administration of any immunoglobulin or blood products within 3 months preceding the
first dose of the study vaccine or plan to use within 7 months.
5. Administration of any attenuated live vaccines within 21 days preceding the first dose
of the study vaccine or any subunit or inactivated vaccines within 14 days before
6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring
systemic antibiotics or antiviral treatment within 5 days before vaccination.
7. Having the plan to participate another clinical trial during the study period.
8. Received another HPV vaccine.
9. Immunodeficiency , primary disease of important organs, malignant tumor, or any immune
disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or
functional asplenia or other disease which might affect immune response).
10. History of allergic disease or history of serious adverse events occurring after
vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
11. Asthma that required emergent treatment, hospitalization, oral or intravenous
corticosteroid for unstable condition within the past 2 years.
12. Having serious disease of internal medicine, such as hypertension, cardiac disease,
diabetes, hyperthyroidism et al.
13. Diagnosed coagulant function abnormality or blood coagulation disorder.
14. Epilepsy, except fever epilepsy at under 2 years of age, alcohol-induced epilepsy in 3
years before abstinence, or idiopathic epilepsy requiring no treatment in the past 3
15. Past or current two-stage affective psychosis, not well controlled in the past 2 years
or requiring drugs, or hve a tendency to commit suicide in the past 5 years.
16. Other medical, psychological, social or occupational factors that, according to the
investigators' judgment, might affect the individual's ability to obey the protocol or
sign the informed consent.
Jiangsu Provincial Centre for Disease Control and Prevention
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Study Chair: Jun Zhang, Master Xiamen University
Principal Investigator: Yue-Mei Hu, Bachelor Jiangsu Provincial Centre for Disease Control and Prevention