Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females

NCT ID: NCT04965350

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-05-16

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.

Conditions

HPV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

2vHPV Consistency Lot 1

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Intervention Type: BIOLOGICAL

sterile solution for intramuscular injection

2vHPV Consistency Lot 2

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Intervention Type: BIOLOGICAL

sterile solution for intramuscular injection

2vHPV Consistency Lot 3

Group Type: EXPERIMENTAL

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Intervention Type: BIOLOGICAL

sterile solution for intramuscular injection

2vHPV Pilot Scale Lot

Group Type: ACTIVE_COMPARATOR

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

Intervention Type: BIOLOGICAL

sterile solution for intramuscular injection

Interventions

Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)

sterile solution for intramuscular injection

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuxi Zerun Biotechnology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Shanghai Zerun Biotechnology Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ting Huang

Role: PRINCIPAL_INVESTIGATOR

Sichuan Center for Disease Control and Prevention

Locations

Mianyang Center for Disease Control and Prevention

Mianyang, Sichuan, China

Countries

China

Other Identifiers

311-HPV-1005

Identifier Type: -

Identifier Source: org_study_id