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Completed

NCT Number: NCT04965350

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

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.

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Key information

Age range

9 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mianyang Center for Disease Control and Prevention

Mianyang, Sichuan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

sterile solution for intramuscular injection

Primary outcomes

  1. Geometric Mean Titers (GMTs) for HPV-16 and/or HPV-18 at one month post 3rd dose

    Time frame: At Month 7

  2. Percentage of participants who seroconvert to HPV-16 and/or HPV-18 at one month post 3rd dose

    Time frame: At Month 7

    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.

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (TEAE) during 30 days after each dose

    Time frame: 0~30 days after each vaccination

  2. Incidence of solicited adverse events (AEs) after vaccination

    Time frame: 0~7 days after each vaccination

  3. Incidence of unsolicited AEs after vaccination

    Time frame: 0~30 days after each vaccination

  4. Incidence of serious adverse events (SAEs)

    Time frame: Month 0 to Month 7

Sponsors and collaborators

Lead sponsor

Shanghai Zerun Biotechnology Co.,Ltd

Industry

Collaborators

  • Yuxi Zerun Biotechnology Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 16, 2021
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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