Clinical trial NCT04965350: Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
Official title: A Phase III, Randomized, Double-blind Study to Assess the Consistency of the Immunogenicity of Three Consecutive Production Lots of Bivalent HPV Vaccine in Healthy Female Subjects Aged 9 - 30 Years and to Demonstrate Non-inferiority of the Candidate HPV Vaccine Manufactured at Commercial Scale Compared With a Pilot Scale
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HPV Infection
Lead sponsor: Shanghai Zerun Biotechnology Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Yuxi Zerun Biotechnology Co., Ltd.
First posted: 2021-07-16
Enrollment: 1100
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9 - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at commercial scale compared with a pilot scale.


Eligibility criteria: Inclusion Criteria:

* 9-30 healthy female able to provide legal identification.
* Written informed consent had to be obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent had to be obtained from a parent or legal guardian of the subject and, in addition, the subject had to sign and personally date a written informed assent).
* Women of child-bearing age(WOCBA): Subject had to have a negative urine pregnancy test, no plan to be pregnant in 7 months, and agree to use adequate contraceptive precautions during study period.

Exclusion Criteria:

* Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial.
* History of abnormal cervical screen test result (ASC-US or worse) or history of genital warts.
* History of severe allergic reaction that required medical intervention.
* History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
* Pregnant or breastfeeding, or within 6 weeks after the end of pregnancy.
* Fever prior to vaccination (auxiliary temperature ≥37.3 °C).
* Hypertension (physical examination systolic blood pressure 140mmHg and or diastolic blood pressure 90mmHg.
* Received live attenuated vaccine within 15 days before vaccination or subunit or inactivated vaccine within 7 days.
* Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
* Acute diseases or acute stage of the chronic diseases within 3 days preceding the vaccination.
* According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.

Primary outcomes:
measure: Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose
timeFrame: At Month 7
measure: Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose
timeFrame: At Month 7
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose
timeFrame: 0~30 days after each vaccination
measure: Incidence of solicited adverse events (AEs) after vaccination
timeFrame: 0~7 days after each vaccination
measure: Incidence of unsolicited AEs after vaccination
timeFrame: 0~30 days after each vaccination
measure: Incidence of serious adverse events (SAEs)
timeFrame: Month 0 to Month 7
Other outcomes:
Locations:
city: Mianyang
country: China
facility: Mianyang Center for Disease Control and Prevention
state: Sichuan
Study officials:
affiliation: Sichuan Center for Disease Control and Prevention
name: Ting Huang
role: PRINCIPAL_INVESTIGATOR
References: