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Immunogenicity and Safety Study of NBP615 in Healthy Female

NCT04453241 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-01

No results posted yet for this study

Summary

This was a randomized, double-blind, active-controlled, phase I/II clinical trial to enroll 200 healthy female including 80 healthy adult aged 19 to 26 years and 120 adolescents aged 9 to 13 years.

Conditions

Interventions

BIOLOGICAL

NBP615

Intramuscular injection, 0.5ml

BIOLOGICAL

Gardasil

Intramuscular injection, 0.5ml

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • k Zaman, MD · International Centre for Diarrhoeal Disease Research, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-22
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • South Korea

Study Locations

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Entities

Drugs
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 NCT04453241 on ClinicalTrials.gov