Immunobridging Study of 9- Valent Human Papillomavirus (9vHPV) Vaccine (V503) in Chinese Females 9 to 45 Years of Age (V503-024) - Trial NCT03903562
Access comprehensive clinical trial information for NCT03903562 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 1990 participants.
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Study Focus
Sponsor & Location
Merck Sharp & Dohme Corp.
Timeline & Enrollment
Phase 3
Apr 27, 2019
Jan 18, 2025
Primary Outcome
Stage I: Competitive Luminex Immunoassay (cLIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age and 20 to 26 Years of Age: Month 7,Stage I: Percentage of Participants 27 to 45 Years of Age and 20 to 26 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 7,Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 Years of Age: Month 12,Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month24,Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 36,Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 48,Stage II: cLIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 60,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48,Stage II: Percentage of Participants 9 to 19 years of Age Who Are Seropositive by cLIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60,Stage II: Immunoglobulin G Luminex Immunoassay (IgG LIA) GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 12,Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 24,Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 36,Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 48,Stage II: IgG LIA GMTs for HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in Participants 9 to 19 years of Age: Month 60,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 12,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 24,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 36,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 48,Stage II: Percentage of Participants 9 to 19 Years of Age Who Are Seropositive by IgG LIA to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58: Month 60
Summary
This study will investigate the immunogenicity and safety of the 9vHPV vaccine in healthy
 Chinese females 9 to 45 years of age. The study consists of Stage I (Day 1 to Month 7) and
 Stage II (post Month 7 to Month 60). Stage II will report the long-term immunogenicity and
 safety in the 9-19 year-old age group only. The dual-primary hypotheses of Stage I are that
 9vHPV vaccine induces non-inferior immune responses in females 9 to 19 years of age who are
 seronegative at Day 1 to the relevant HPV type compared to females 20 to 26 years of age who
 are seronegative at Day 1 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18,
 31, 33, 45, 52, and 58 GMTs at 1 month post Dose 3, and 9vHPV vaccine induces non-inferior
 immune responses in females 27 to 45 years of age who are seronegative at Day 1 to the
 relevant HPV type compared to females 20 to 26 years of age who are seronegative at Day 1 to
 the relevant HPV type, as measured by the seroconversion percentages to each of HPV types 6,
 11, 16, 18, 31, 33, 45, 52, and 58 at 1 month post Dose 3. (Each vaccine component will be
 analyzed separately.)
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT03903562
Non-Device Trial