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Strengthening HPV Immunization Through EPI Leveraged Delivery

NCT07377656 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-05-18

No results posted yet for this study

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.

Conditions

  • HPV Vaccine

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

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Noguchi Memorial Institute for Medical Research

    collaborator OTHER

  • Dodowa Health Research Centre

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Julia Lynch, MD · International Vaccine Institute

  • George Armah, Prof. PhD · Noguchi Memorial Institute for Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
9 Months
Max Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-02-29
Completion
2028-12-31

Countries

  • Ghana

Study Locations

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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 NCT07377656 on ClinicalTrials.gov