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NOT YET RECRUITING
NCT07888686
PHASE1/PHASE2

Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine

Sponsor: Serum Institute of India Pvt. Ltd.

View on ClinicalTrials.gov

Summary

Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. This study will assess an experimental vaccine called 10 valent Human Papillomavirus Virus (10vHPV) for the safety, reactivity, and immune response, in healthy adults, compared to Gardasil 9. There are two phases in this study - Phase 1 will include up to 36 healthy adults aged 18-25 years, Phase 2 will include 36 healthy adults aged 26-45 years. Participants will be randomised in a 2-to-1 ratio to receive either 10vHPV or Gardasil 9. 10vHPV or Gardasil 9 will be administered as a 0.5 mL single dose via intramuscular injection in the deltoid muscle of the upper arm. In Phase 1, participants will receive a single dose on Day 1, and in Phase 2, participants will receive a single dose on Day 1, 2 months, and 6 months.

Official title: A Phase 1/2, Double-blinded, Randomised, Active Controlled, Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine in Comparison With Gardasil 9 Vaccine in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-10

Completion Date

2028-04

Last Updated

2026-10-22

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

10vHPV

10vHPV is manufactured by Serum Institute of India Pvt. Ltd and is a 10-valent recombinant VLP vaccine containing the major capsid (L1) protein

BIOLOGICAL

Gardasil9

Gardasil9 is manufactured by Merck Sharp \& Dohme (MSD) and is a 9-valent recombinant VLP vaccine containing the major capsid (L1) protein

Locations (1)

Doherty Clinical Trials Limited

East Melbourne, Victoria, Australia