Gardasil Immunogenicity With Needle-Free Injection

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.

Timeline

Start

2014-01

Primary completion

2022-12-15

Completion

2023-02-16

Drugs

Indications