Brief Title
A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls
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
Brief Summary
This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen
Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the
immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in
girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the
standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the
difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).
Detailed Description
Totally 750 healthy girls of 9-17 years and 225 healthy young women of 18-26 years were
enrolled. The subjects of 9-14 years will be stratified into 2 subset. Subjects in each
subsets will be randomly assigned into the standard 0-1-6m schedule group or an alternative
0-6m group. All subjects of 15-26 years of age will receive the standard 0-1-6m schedule.
Participants were actively monitored for adverse events for 1 month after each injection.
Severe adverse events during the trial were followed up. Serum samples from all the subjects
would be collected on day 0, 6m, 7m to evaluate the immunogenicity.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Anti-HPV16 and anti-HPV18 seroconversion rates and geometric mean concentrations at Months 7 (type specific IgG antibody)
Secondary Outcome
Number of Participants with Adverse Events
Condition
Cervical Intraepithelial Neoplasia
Intervention
3 doses of HPV 16/18 bivalent vaccine
Study Arms / Comparison Groups
9-17y (0,1,6m)
Description: Participants in this arm would receive 60μg of HPV 16/18 bivalent vaccine according to 3 doses of HPV 16/18 bivalent vaccine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
979
Start Date
December 5, 2015
Completion Date
August 12, 2016
Primary Completion Date
August 12, 2016
Eligibility 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;
Gender
Female
Ages
9 Years - 26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ting Wu, Ph. D., ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02562508
Organization ID
HPV-PRO-006
Responsible Party
Sponsor-Investigator
Study Sponsor
Jun Zhang
Collaborators
Xiamen Innovax Biotech Co., Ltd
Study Sponsor
Ting Wu, Ph. D., Study Chair, Xiamen University
Verification Date
August 2018