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

HPV Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04965350
• Other study ID #: 311-HPV-1005
• Status: Completed
• Phase: Phase 3
• Start date: April 20, 2021
• Est. completion date: May 16, 2022

Study information

• Verified date: April 2023
• Source: Shanghai Zerun Biotechnology Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: May 16, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

Biological:
• Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)
sterile solution for intramuscular injection

Locations

Country	Name	City	State
China	Mianyang Center for Disease Control and Prevention	Mianyang	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Zerun Biotechnology Co.,Ltd	Yuxi Zerun Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose		At Month 7
Primary	Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose	Seroconversion was defined as: For initially seronegative subjects [antibody titer below (<) 1:40 prior to vaccination], antibody titer greater than or equal to (=) 1:40 after vaccination; For initially seropositive subjects (antibody titer = 1:40 prior to vaccination), antibody titer after vaccination = 4 fold the pre-vaccination antibody titer.	At Month 7
Secondary	Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose		0~30 days after each vaccination
Secondary	Incidence of solicited adverse events (AEs) after vaccination		0~7 days after each vaccination
Secondary	Incidence of unsolicited AEs after vaccination		0~30 days after each vaccination
Secondary	Incidence of serious adverse events (SAEs)		Month 0 to Month 7