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Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

An Randomized, Double-Blinded, Placebo Controlled Phase II Clinical Trial to Estimate Immunogenicity of the Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type) (E.Coli) in Healthy Adults Aged 18 to 45 Years

NCT03935204•Xiamen University

View on ClinicalTrials.gov

Summary

This phase II clinical study was designed to evaluate the immunogenicity and safety of Recombinant Human Papillomavirus Vaccine (6,11,16,18,31,33,45,52,58 Type)(E.Coli)(hereafter called HPV vaccine), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults aged 18-45 years old.

Eligibility

Age

18 - 45 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Health women aged between 18 and 45 years.
•2. Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
•3. Able to comply with the requests of the study.
•4. Written informed consent obtained from the participants.
•5. Axillary temperature not higher than 37.0°C
•6. Non-pregnant women verified by a urine pregnancy test.

Exclusion Criteria

•1. Pregnant or breastfeeding or plan to be pregnant within 7 months.
•2. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
•3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
•4. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine or plan to use within 7 months.
•5. Administration of any attenuated live vaccines within 21 days preceding the first dose of the study vaccine or any subunit or inactivated vaccines within 14 days before vaccination.
•6. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
•7. Having the plan to participate another clinical trial during the study period.
•8. Received another HPV vaccine.
•9. Immunodeficiency , primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
•10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy, urticaria, dyspnea, angioneurotic edema or abdominal pain.
+6 more criteria

Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention

Nanjing, Jiangsu, China

Key Dates

Start Date

May 13, 2019

Primary Completion Date

October 18, 2019

Completion Date

April 1, 2021

Last Updated

April 8, 2021

Enrollment

627

ACTUAL participants

Conditions

Condylomata AcuminataCervical Cancer

Interventions

HPV Vaccine,270μg/1.0ml

BIOLOGICAL

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Immunogenicity Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)

Inclusion Criteria

Exclusion Criteria

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