MedTrace Logo

A Phase I Safty and Immunogenicity Study of SCT1000 in Healthy Women Aged 18 to 45 Years

NCT04921111 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-09-17

No results posted yet for this study

Summary

A phase 1 random, double blind, positive and placebo control trail was conducted in 120 healthy women in the arm A: 18-26 years old and Arm B: 27-45 years old. The 40 subjects to be inoculated with low, middle, and high dose vaccinefirst in sequence if there was no safety issue. In each dose group SCT1000 : placebo: positive =3:1:1.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, and the vaccination of this dose group or higher dose group will not be carried out, and the study of other dose groups will continue. If this happens at a low dose, the study will be suspended / terminated.

Conditions

  • HPV Infection Vaccine Safety SCT1000

Interventions

DRUG

SCT1000

Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)

DRUG

Gardasil®9

Recombinant 9 or 4 valent human papillomavirus vaccine

DRUG

placebo

aluminium phosphate

DRUG

Gardasil®

Recombinant 4 valent human papillomavirus vaccine

Sponsors & Collaborators

  • Sinocelltech Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2022-07-31
Completion
2022-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04921111 on ClinicalTrials.gov