Clinical trial NCT06197802: Plateau Antibody Levels of a Recombinant (E.Coli) HPV Nonavalent Vaccine Versus Gardasil®9 in Young Women
Official title: An Observational Study to Compare Plateau Antibody Levels of a Recombinant (E.Coli) Human Papillomavirus Nonavalent (Type 6/11/16/18/31/33/45/52/58) Vaccine Versus Gardasil®9 in Healthy Females 18-26 Years of Age
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cervical Cancer
Condylomata Acuminata
Keywords: human papillomavirus vaccine
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
First posted: 2024-01-09
Enrollment: 392
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 type specific neutralizing antibody level
timeFrame: 30-36 months after the first dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Centre for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Xiamen University
name: Jun Zhang, master
role: STUDY_CHAIR
affiliation: Jiangsu Provincial Centre for Disease Control and Prevention
name: Feng-cai Zhu, master
role: PRINCIPAL_INVESTIGATOR
References: