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NCT04708041

Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen With Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared With a Standard 3-dose Regimen in 16- to 26-Year Old Women
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
Daly City,Oakland,Roseville,Sacramento,Sacramento,San Jose,Santa Clara,Spring Valley,Naples,Greenville,North Charleston,Corpus Christi,Galveston,Cheney,Medellín,Chia,Mexico City,Morelia,Monterrey,Meri, Colombia,Mexico,Poland,South Africa,Taiwan,United States of America
Timeline & enrollment
Phase
Phase 3
Start date
Mar 15, 2021
End date
Jun 18, 2029
Enrollment
700 participants
Primary outcome

Geometric Mean Titers of Anti-Human Papilloma Virus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 as Measured by Competitive Luminex Immunoassay,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 Vaccine-Related Adverse Event

Summary

This is a 96-month safety and immunogenicity study conducted in boys and girls 9 to 14 years
 of age and in young women 16 to 26 years of age. From this study, the goal is to establish
 that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months;
 and 0, 60 months) studied in boys and girls 9 to 14 years of age are generally safe and
 immunogenic, with an antibody response that is not inferior to that observed in young women
 16 to 26 years of age who receive the standard 3-dose regimen of 9-valent human
 papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen
 used to establish 9vHPV vaccine efficacy).

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
NCT04708041
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04708041 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 700 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.