NCT04772534

Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)

Name: Clinical Trial NCT04772534
Creator: Merck Sharp & Dohme Corp.
Keywords: Papillomavirus Infections, 9vHPV vaccine, Phase 3, biological, clinical trial, Japan

A Phase 3, Open-label Clinical Study to Evaluate the Immunogenicity and Safety of 9vHPV Vaccine, in Japanese Boys and Girls, 9 to 15 Years of Age.

Merck Sharp & Dohme Corp.·Phase 3·ClinicalTrials.gov·biologicalNot yet recruiting

View on ClinicalTrials.gov →

Study focus

Disease/Condition: Papillomavirus Infections
Drug/Device/Intervention: 9vHPV vaccine
Study type: Interventional
Intervention type: biological

Sponsor & location

Primary sponsor: Merck Sharp & Dohme Corp.
Location: Isumi-shi,Sapporo,Sapporo,Sakai,Fukui,Osaka,Osaka,Tokyo,Tokyo,Tokyo,Tokyo,Tokyo, Japan

Timeline & enrollment

Phase: Phase 3
Start date: May 17, 2021
End date: Apr 26, 2024
Enrollment: 300 participants

Primary outcome

Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58,Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event,Percentage of Participants With at Least 1 Systemic Adverse Event,Percentage of Participants With at Least 1 Serious Adverse Event,Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event

Summary

The primary objective of this study is the estimation of the human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52 and 58 seroconversion at 1 month post last dose (Month 7) following 3 doses and 2 doses of the 9vHPV vaccine. No hypothesis will be tested since this study is an estimation-only study.

ICD-10 classifications

Papillomavirus as the cause of diseases classified to other chaptersPapovavirus infection, unspecified sitePapilloedema, unspecifiedViral infection, unspecifiedParvovirus as the cause of diseases classified to other chapters

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT04772534
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT04772534 through Pure Global AI's free database. This Phase 3 trial is sponsored by Merck Sharp & Dohme Corp. and is currently Not yet recruiting. The study focuses on Papillomavirus Infections. Target enrollment is 300 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.