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Gardasil Immunogenicity With Needle-Free Injection

NCT02363660 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-02-17

No results posted yet for this study

Summary

1. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given low doses of vaccine by the ID route with the NFI (Group III) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 18 months following completion of the vaccination series.
2. Compare rates of seroconversion and GMTs generated following a 3-dose series of vaccine in women given standard doses of vaccine by the IM route with the NFI (Group II) to those women given standard doses by the IM route with a needle and syringe (Group I) at 1 month, 6 months and 18 months following completion of the vaccination series.

Conditions

Interventions

BIOLOGICAL

GINI

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2022-12-15
Completion
2023-02-16

Countries

  • Thailand

Study Locations

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Entities

Diseases
Companies

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 NCT02363660 on ClinicalTrials.gov