Cervical Cancer
Conditions
Keywords
vaccine, safety, immunogenicity
Brief summary
This study evaluates the safety of Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha) in women of 9 to 30 years old and men of 9 to 17 years old and preliminarily explore the immunogenicity. 135 people are enrolled in total, including 45 women of 18 to 30 years old and 90 people of 9 to 17 years old. Among the first group, 30 women will be inoculated studied vaccine and 15 women will be inoculated placebo. Among the second group, there are 45 women and 45 men, 30 women and 30 men in vaccine group and 15 women and 15 men in placebo group.
Interventions
BIOLOGICALTetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)
Injection vaccine produced by Beijing institute of biological products co., LTD, containing HPV antigen protein, 120μg/0.5ml/bottle
BIOLOGICALplacebo
Sponsors
Beijing Chaoyang District Centre for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
9 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Requirements of age: males of 9 to 17 years old, females of 9 to 30 years old. * Willing to provide the statutory certificate of identity. * For subjects of 18 to 30 years old, they should be able to understand the clinical trials and agreed to sign the informed consent; for subjects of 9 to 17 years old, their guardian should be able to understand the clinical trial, and sign informed consent together with subjects. * Female subjects have no pregnancy and birth plans in the 7 months after being enrolled, and agree to take effective contraception during this period.
Exclusion criteria
* People with history of cervical cancer or HPV infection related diseases such as condyloma * People with a history of severe allergic reactions requiring medical intervention (such as garget, difficult breathing, hypotension or shock) * People with a history of serious side effects after vaccination or severe allergic reaction to food or drugs * People with epilepsy or a history of mental illness * People in immune deficiency or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases, people with immunosuppressive therapy in the past six months. * People with serious liver or kidney disease, cardiovascular disease, severe hypertension, diabetes, cancer, all kinds of infectious disease and acute disease or in acute attack period of chronic diseases * Asplenia, functional asplenia, and any situation leading to asplenia or splenectomize. * People diagnosed by doctors with coagulation dysfunction (such as the lack of clotting factors, disorders of blood coagulation and blood platelet disorders), apparent bruises or blood coagulation disorders; * People given whole blood, plasma or immunoglobulin therapy within 3 months before vaccination. * People get any vaccine within 14 days before the trial. * People with fever before vaccination, axillary temperature higher than 37.0 ℃. * Females in suckling period, pregnancy (pregnancy test positive) or prepared to be pregnant. * People with abnormal laboratory index. (slight abnormity is except if judged with no clinical significance by doctors.) * People has gotten HPV vaccine before; people has used or plans to use other vaccine or unregistered products (drugs or vaccines) within 30 days before the first dose; people plans to participate in other clinical trials within 6 months after this clinical trial. * According to judgement of researchers, the subjects have any other factors that are not appropriate for this clinical trials. The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Rate of Adverse reactions of Human Papilloma Virus Vaccine in Women Aged 9 to 30 and Men Aged 9 to 17 | 30 days | Adverse reactions associated with vaccine will be observed in subjects after vaccination. Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site. solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the seroconversion rate of HPV antibodies in serum after vaccination. | 30 days | The seroconversion rate will be evaluated at 30 days after vaccination. |
Outcome results
None listed