A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02562508
• Date of registration: 14/09/2015
• Prospective Registration: Yes
• Primary sponsor: Jun Zhang
• Public title: A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
• Scientific 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
• Date of first enrolment: December 5, 2015
• Target sample size: 979
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02562508
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Ting Wu, Ph. D.
• Affiliation: Xiamen University

• Name: Yuemei Hu, Bachelor
• Affiliation: Jiangsu Provincial Centre for Disease Control and Prevention

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Females aged between 9 and 26 years when they receive the first vaccination
(9=age<27);

2. Participants aged 9-17 years whose legal guardian can provide identity certificate, or
representative can provide authorization;

3. Judged as healthy and eligible for vaccination by the investigators through a
self-reported medical history and some physical examinations;

4. 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;

5. Able to comply with the requests of the study;

6. Axillary temperature not higher than 37.0°C;

7. Nonpregnancy verified by a urine pregnancy test;

Exclusion criteria:

1. Pregnant or lactating woman and any woman who are willing or intend to become pregnant
in next 7 months;

2. 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;

3. 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);

4. Participants who received immunoglobulin and/or blood product 3 months prior to the
first vaccination, or planned to receive during the study period;

5. Use of any inactivated vaccine 14 days preceding dosing of study vaccine or attenuated
vaccine 21 days before the enrollment;

6. 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;

7. Concurrently participating another clinical trial;

8. Participants who have received HPV vaccines;

9. 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.;

10. 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;

11. Participants with asthma, which is unstable in the past 2 years, requiring emergency
treatment, hospitalization, or oral or intravenous corticosteroid;

12. Participants with concurrent severe medical disorders, such as hypertension, heart
disease, diabetes mellitus, or hyperthyroidism, etc.;

13. Participants with coagulation dysfunction (such as coagulation factor deficiency,
blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed
by a physician;

14. 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;

15. 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;

16. 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;



Age minimum: 9 Years
Age maximum: 26 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Vulvar Intraepithelial Neoplasia

Cervical Cancer

Persistent Infection

Cervical Intraepithelial Neoplasia

Vaginal Intraepithelial Neoplasia

Intervention(s)

Procedure: 2 doses of HPV 16/18 bivalent vaccine

Procedure: 3 doses of HPV 16/18 bivalent vaccine

Primary Outcome(s)

Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody) [Time Frame: Month 7]

Secondary Outcome(s)

Number of Participants with Adverse Events [Time Frame: Month 7]

Secondary ID(s)

HPV-PRO-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Xiamen Innovax Biotech Co., Ltd