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

NCT04965350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2023-04-13

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

sterile solution for intramuscular injection

Sponsors & Collaborators

  • Yuxi Zerun Biotechnology Co., Ltd.

    collaborator UNKNOWN

  • Shanghai Zerun Biotechnology Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Ting Huang · Sichuan Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-20
Primary Completion
2022-04-27
Completion
2022-05-16

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965350 on ClinicalTrials.gov