Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Jiangsu Provincial Centre for Disease Control and Prevention

Dongtai, Jiangsu, 224200, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent from the subject prior to enrolment;
Female between, and including, 18 and 55 years of age at the time of enrolment;
Subjects must be free of obvious health problems;
Not pregnant and having no plan for pregnancy;

Exclusion criteria

Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
Previous vaccination against HPV;
Having severe allergic history or other immunodeficiency;
Chemotherapy and other immunosuppressive agents using;

Treatment and study plan

HPV 16/18

Biological

Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

Primary outcomes

Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination.

Time frame: 7 months

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
Xiamen Innovax Biotech Co., Ltd

Registry information

Official study title

An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Dec 20, 2010
Registry last updated: Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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