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A Phase II Study of SCT1000 in Healthy Women Aged 18 to 45 Years

NCT05060484 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1800

Last updated 2021-10-28

No results posted yet for this study

Summary

A phase II random, double blind, positive and placebo control trail was conducted in 1200 healthy women in the arm A: 18-26 years old and 600 healthy women in the Arm B: 27-45 years old. The 1800 subjects to be inoculated with middle, and high dose vaccine. Middle dose SCT1000: hight dose SCT1000: placebo: positive control =1:1:1:1.Two arms can be recruited at the same time. If the DSMB assessment shows that the adverse events of a certain dose group meet the criteria of suspension / termination, the dose group will be suspended / terminated.

Conditions

  • Interventional
  • Prevention
  • Randomized

Interventions

BIOLOGICAL

SCT1000

HPV vaccine

BIOLOGICAL

Gardasil®9

HPV vaccine

BIOLOGICAL

Gardasil®

HPV vaccine

OTHER

placebo

adjuvent

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Principal Investigators

  • Fengcai Zhu · Jiangsu Province CDC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2022-05-31
Completion
2022-07-31

Countries

  • China

Study Locations

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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 NCT05060484 on ClinicalTrials.gov