A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
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ClinicalTrials.gov Identifier: NCT02562508 |
Recruitment Status :
Completed
First Posted : September 29, 2015
Last Update Posted : August 16, 2018
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Condition or disease | Intervention/treatment | Phase |
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Cervical Intraepithelial Neoplasia Cervical Cancer Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia Persistent Infection | Procedure: 3 doses of HPV 16/18 bivalent vaccine Procedure: 2 doses of HPV 16/18 bivalent vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 979 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety Study of a Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years |
Actual Study Start Date : | December 5, 2015 |
Actual Primary Completion Date : | August 12, 2016 |
Actual Study Completion Date : | August 12, 2016 |

Arm | Intervention/treatment |
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Experimental: 9-17y (0,1,6m)
Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
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Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months) |
Experimental: 9-14y (0,6m)
Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 2 doses of HPV 16/18 bivalent vaccine
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Procedure: 2 doses of HPV 16/18 bivalent vaccine
Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months) |
Experimental: 18-26y (0,1,6m)
Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
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Procedure: 3 doses of HPV 16/18 bivalent vaccine
Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months) |
- Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) [ Time Frame: Month 7 ]To detect the anti-HPV 16 and anti-HPV 18 type specific IgG antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3
- Number of Participants with Adverse Events [ Time Frame: Month 7 ]All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.
- Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific neutralizing antibody) [ Time Frame: Month 7 ]To detect the anti-HPV 16 and anti-HPV 18 type specific neutralizing antibody level on day 0 (before the 1st dose) ,six month after the dose 1 (before the 3rd dose) and one month after dose 3

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Ages Eligible for Study: | 9 Years to 26 Years (Child, Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Females aged between 9 and 26 years when they receive the first vaccination (9≤age<27);
- Participants aged 9-17 years whose legal guardian can provide identity certificate, or representative can provide authorization;
- Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations;
- Participants aged 9-17 years, able to sign or whose legal guardian agree to sign the written informed consent; or participants aged 18-26 years and agree to sign the written informed consent;
- Able to comply with the requests of the study;
- Axillary temperature not higher than 37.0°C;
- Nonpregnancy verified by a urine pregnancy test;
Exclusion criteria:
- Pregnant or lactating woman and any woman who are willing or intend to become pregnant in next 7 months;
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first vaccination, or plan to use during the study period;
- Participants who received an immunosuppressive agent or other immunomodulator agent for a long term (for 14 days or more) within 6 months of the first vaccination, or systematic corticosteroid (however, a topical corticosteroid is allowed, such as ointment, eye drops, inhalant, or nasal spray);
- Participants who received immunoglobulin and/or blood product 3 months prior to the first vaccination, or planned to receive during the study period;
- Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated vaccine 21 days before the enrollment;
- Participants had fever (auxiliary temperature ≥38.0 °C) within 3 days prior to vaccination, or any acute disease requiring systematic antibiotics or antiviral therapy within the past 5 days;
- Concurrently participating another clinical trial;
- Participants who have received HPV vaccines;
- Participants with immunodeficiency disease (such as HIV positive), primary disease in vital organs, cancer (or precancerous lesion), or chronic history of immunological disease requiring treatment (including systemic lupus erythematosus), rheumatoid arthritis, asplenia or splenectomy due to any conditions, and other immunological diseases that may impact immune response as considered by investigator), etc.;
- Participants with a history of allergy, including severe adverse reactions due to the past vaccination, such as hypersensitivity, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
- Participants with asthma, which is unstable in the past 2 years, requiring emergency treatment, hospitalization, or oral or intravenous corticosteroid;
- Participants with concurrent severe medical disorders, such as hypertension, heart disease, diabetes mellitus, or hyperthyroidism, etc.;
- Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician;
- Participants with epilepsy, excluding febrile epilepsy in patients under 2 years old, alcoholic epilepsy 3 years prior to alcohol abstinence, or pure epilepsy requiring no treatment within the past 3 years;
- Participants who are not compliant to the study's requirements due to psychological conditions, or those with prior or existing mental disease or bipolar psychosis which are not well controlled within the past 2 years and require taking drugs, or those with suicidal tendency within the past 5 years;
- According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562508
China, Jiangsu | |
Jiangsu Provincial Centre for Disease Control and Prevention | |
Nanjing, Jiangsu, China, 210009 |
Study Chair: | Ting Wu, Ph. D. | Xiamen University | |
Principal Investigator: | Yuemei Hu, Bachelor | Jiangsu Provincial Centre for Disease Control and Prevention |
Responsible Party: | Jun Zhang, professor, Xiamen University |
ClinicalTrials.gov Identifier: | NCT02562508 |
Other Study ID Numbers: |
HPV-PRO-006 |
First Posted: | September 29, 2015 Key Record Dates |
Last Update Posted: | August 16, 2018 |
Last Verified: | August 2018 |
Human Papilloma Virus 16 Human Papilloma Virus 18 vaccine |
adolescent girl bridging trial non-inferiority |
Neoplasms Carcinoma in Situ Cervical Intraepithelial Neoplasia Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Vaccines Immunologic Factors Physiological Effects of Drugs |