Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069) - Trial NCT04708041
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.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
Mar 15, 2021
Jun 18, 2029
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
Data Source
ClinicalTrials.gov
NCT04708041
Non-Device Trial