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NOT YET RECRUITING
NCT07377656
PHASE2

Strengthening HPV Immunization Through EPI Leveraged Delivery

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

Summary

This is a randomized observer-blind placebo-controlled proof-of-concept study with the aim to assess the safety and tolerability, and the immunogenicity of a bivalent HPV vaccine administered in healthy infants and toddlers (9- and 15-month-olds) comparing them to an immune-bridging population of 15-20-year-old unmarried females in an open label study in Ghana at the Dodowa Health Research Center.

Official title: A Randomized, Observer-Blind, Placebo-Controlled, Proof-of-Concept Study to Assess the Safety, Tolerability and Immunogenicity of a Bivalent Human Papillomavirus (HPV) Vaccine in 9 and 15 Month Old Infants and Toddlers, 2-5 Year Old Children and an Open Label Single Dose Study in Young Unmarried Females Aged 15-20 Years in Ghana

Key Details

Gender

All

Age Range

9 Months - 20 Years

Study Type

INTERVENTIONAL

Enrollment

115

Start Date

2026-01-16

Completion Date

2028-12-31

Last Updated

2026-01-30

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

HPV vaccine

0.5 mL HPV Vaccine Injection Intramuscular

BIOLOGICAL

Placebo

0.5 mL Placebo injection intramuscular

BIOLOGICAL

Measles and rubella Vaccine

Measles and rubella Vaccine according to EPI

Locations (1)

Dodowa Health Research Center

Accra, Ghana