Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

Summary: This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.
  The primary hypotheses are as follows:
  1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
  2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
  3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
  4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

Detailed description: The base study V503-002 was a 12-month study that is collecting safety and immunogenicity information for six months following the subjects' third dose of study vaccine.
  An optional extension study (V503-002 EXT1) will collect safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT1.
  An optional second extension study (V503-002 EXT2) will collect long-term safety and immunogenicity information through approximately 10 years. No study vaccine will be administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT2.

Eligibility: Inclusion Criteria:
  Boys and Girls Age 9 to 15:
  -  Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
  Women Age 16 to 26:
  -  Participant has never had Pap testing or has had only normal results
  -  Participant has had 0 to 4 sexual partners at the time of enrollment
  Exclusion Criteria:
  Boys and Girls Age 9 to 15:
  -  History of allergic reaction that required medical intervention
  -  Currently enrolled in any other clinical study
  -  Participant is pregnant
  -  Participant is immunocompromised or has taken immunosuppressants in the last year
  -  Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
  -  Participant has a history of positive test for HPV
  Women Age 16 to 26:
  -  History of allergic reaction that required medical intervention
  -  Currently enrolled in any other clinical study
  -  Participant is pregnant
  -  Participant is immunocompromised or has taken immunosuppressants in the last year
  -  Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
  -  Participant has a history of positive test for HPV
  -  Participant has a history of abnormal cervical biopsy result
  -  Participant has a history of external genital lesions

Relevance to patient case: not relevant