A Phase III Study of Human Papillomavirus (HPV)-16/18 Vaccine.
NCT ID: NCT02733068
Last Updated: 2022-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
12000 participants
INTERVENTIONAL
2014-11-02
2020-01-16
Brief Summary
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Detailed Description
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This study planned to enrol 12000 healthy female aged 18-30 in 10 study sites. Each participants will received a three-dose schedule of vaccine or placebo randomly but with the proportion controlled as 1:1 for vaccine group and placebo group. After each inoculation, the immediate reaction will be observed for 30 minutes, and the local and systemic reaction will be systematically observed for 7 days. After the first inoculation, adverse event will be collected until one month after the final inoculation, while serious adverse event will be collected until 6 months after the final inoculation. Blood samples will be collected before the first inoculation, and one month after the final injection, blood samples will also be collected in a group of participants containing 800 people to detect antibody titer.
Follow-up visit will be conducted 14 times: month 0, month 0 + 8 days, month 2, month 2 + 8 days, month 6, month 6 + 8 days, month 7, month 12, month 18, month 24, month 30, month 36, month 48, month 60. When cervical intraepithelial neoplasia grade 2+ (CIN2+) is indicated, the participant will receive standard treatment and drop out from the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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HPV-16/18 vaccine
Including 6000 participants who received the HPV-16/18 vaccine 0.5ml.
HPV-16/18 vaccine
0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
HPV-16/18 placebo
Including 6000 participants who received the HPV-16/18 placebo 0.5ml.
HPV-16/18 placebo
0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
Interventions
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HPV-16/18 vaccine
0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
HPV-16/18 placebo
0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
Eligibility Criteria
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Inclusion Criteria
* enable to provide an legal identification
* have the ability to understand and sign the Informed Consent Form
* confirmed by the investigator that the participant has the ability to comply with the protocol requirements
* agreed to use effective contraceptive method in 7 months or has no plan of pregnancy
* can avoid vaginal sex within two days (48 hours) before every interview; don't employ a vaginal douche or any other intervention which can influence the gynecological examination and sample collection
Exclusion Criteria
* within three months before the first injection, has had received a whole-blood, plasma or immunoglobulin treatment, or planed to receive such treatments during the research period; within 28 days before the research, has had received attenuated live vaccine; or within 14 days has had received inactivated vaccine
* has a history of allergic reaction which requires medical intervention; has allergic reaction for vaccine or vaccine-containing elements; has serious adverse effect history for vaccine
* has a history of epilepsy, convulsion or has a family history of mental diseases
* has immunodeficiency diseases including: AIDS, HIV infection, lymphoma, leukemia, Systemic Lupus Erythematosus, rheumatoid arthritis, Juvenile Rheumatoid Arthritis, inflammatory bowel disease
* used immunosuppressor for treatment or corticosteroid drugs for systemic medication in 6 months
* asplenia, functional asplenia, or splenectomize
* liver and kidney diseases, serious cardiovascular diseases, diabetes, history of malignant tumor
* coagulation disorders
* in menstrual period or acute diseases
* pregnant, or less than 8 weeks after delivery
* has a history of sexual transmitted disease
* had total hysterectomy or pelvic radiotherapy
* has cervical abnormalities
* abnormal screening results for cervical cancer or had CIN in two years
* according to the judgement of investigator, participant has conditions that were not suitable for this trial
* planning to move out of the clinical trial site during the research period
* never has vaginal sexual activity
18 Years
30 Years
FEMALE
Yes
Sponsors
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Guangxi Center for Disease Control and Prevention
OTHER_GOV
Shanghai Zerun Biotechnology Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Zhaojun Mo
Role: PRINCIPAL_INVESTIGATOR
Guangxi Center for Disease Prevention and Control(GXCDC)
Other Identifiers
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311-HPV-1003
Identifier Type: -
Identifier Source: org_study_id