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Immunogenicity and Safety of Dengue Tetravalent Vaccine (TDV) and Recombinant 9-valent Human Papillomavirus Vaccine (9vHPV) in Participants Aged ≥9 to <15 Years

NCT04313244 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2024-02-07

Study results available
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Summary

The purpose of the study is to demonstrate the non-inferiority (NI) of the immune response to 2 doses of 9vHPV vaccine, 1 co-administered with TDV, compared with 2 doses of 9vHPV vaccine administered alone.

Conditions

  • Dengue Fever

Interventions

BIOLOGICAL

9vHPV Vaccine

9vHPV intramuscular injection

BIOLOGICAL

Dengue Tetravalent Vaccine (TDV)

TDV subcutaneous injection

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2022-02-21
Completion
2022-07-19
FDA Drug
Yes

Countries

  • Thailand

Study Locations

More Related Trials

Entities

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 NCT04313244 on ClinicalTrials.gov