Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

392 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-30

Study Completion Date

2025-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to compare plateau antibody levels of a novel recombinant human papillomavirus vaccine (types 6,11,16,18,31,33,45,52,58 )(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., with Gardasil®9 in females 18-26 Years of Age.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) Versus Gardasil®9 in Healthy Females 18-26 Years of Age

NCT04782895

Cervical Cancer Condylomata Acuminata

COMPLETED PHASE3

An Immuno-bridging Study of a Nonavalent HPV Vaccine (E.Coli) in Healthy Population Aged 9-17 vs Aged 18-26 Years Old

NCT05056402

Cervical Cancer Condylomata Acuminata

ACTIVE_NOT_RECRUITING PHASE3

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

NCT02562508

Cervical Intraepithelial Neoplasia Cervical Cancer Vaginal Intraepithelial Neoplasia +2 more

COMPLETED PHASE3

A Study to Evaluate the Immunogenicity and Safety of HPV Vaccine in Healthy Female Participants Aged 9-26 Years in China

NCT05662020

Human Papillomavirus Infection

ACTIVE_NOT_RECRUITING PHASE3

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

NCT03935204

Condylomata Acuminata Cervical Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer Condylomata Acuminata

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) group

Subjects would receive 3 doses of 270μg/0.5ml Recombinant HPV nonavalent (Types 6/11/16/18/31/33/45/52/58) Vaccine(E.Coli)

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Intervention Type BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Gardasil®9 group

Subjects would receive 3 doses of 270μg/0.5ml Gardasil®9

Gardasil®9

Intervention Type BIOLOGICAL

Three doses administered intramuscularly at 0, 45 day and 6 month.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)

Three doses administered intramuscularly at 0, 45 day and 6 month.

Intervention Type BIOLOGICAL

Gardasil®9

Three doses administered intramuscularly at 0, 45 day and 6 month.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subject who had previously participated in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895), and received at least one dose ;
* Subject is able to understand and comply with the requirements of the protocol(e.g. biological specimen collection, return for follow-up visits), and written informed consent must be obtained from the subject prior to enrollment;

Exclusion Criteria

* Subject who had used other HPV vaccine products (including marketed and unmarketed vaccines) after participating in the Randomized, Single-blind Study to Compare Immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine(E.Coli) (Xiamen Innovax Biotech Co.,Ltd.) Versus Gardasil®9 (Merck \& Co., Inc.) in Healthy Females 18-26 Years of Age (Protocol No.: HPV-PRO-011, Identifiers: NCT04782895) ;
* Subject has abnormal coagulation function (such as coagulation factor deficiency, coagulopathy, platelet abnormalities) or coagulation disorders;
* Medical, psychological, social conditions, occupation or other factors, which considered by the investigator that may influence the conduct of the clinical study.

Minimum Eligible Age

20 Years

Maximum Eligible Age

28 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes