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

Shanghai Zerun Biotechnology

Status and phase: Completed; Phase 3

Conditions: HPV Infection

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04965350

311-HPV-1005

Details and patient eligibility

About

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.

Enrollment: 1,100 patients

Sex: Female

Ages: 9 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,100 participants in 4 patient groups

2vHPV Consistency Lot 1

Experimental group

Treatment:

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

2vHPV Consistency Lot 2

Experimental group

Treatment:

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

2vHPV Consistency Lot 3

Experimental group

Treatment:

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

2vHPV Pilot Scale Lot

Active Comparator group

Treatment:

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