A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 1

  Measured over: Within 7 days after vaccine Dose 1 (administered at Day 1)

• Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 2

  Measured over: Within 7 days after vaccine Dose 2 (administered at Month 2)

• Number of Participants Reporting Grade 3 Solicited Administration Site Events After Vaccine Dose 3

  Measured over: Within 7 days after vaccine Dose 3 (administered at Month 6)

• Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 1

  Measured over: Within 7 days after vaccine Dose 1 (administered at Day 1)

• Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 2

  Measured over: Within 7 days after vaccine Dose 2 (administered at Month 2)

• Number of Participants Reporting Grade 3 Solicited Systemic Events After Vaccine Dose 3

  Measured over: Within 7 days after vaccine Dose 3 (administered at Month 6)

• Number of Participants Reporting Grade 3 Unsolicited Adverse Events (AEs) After Vaccine Dose 1

  Measured over: Within 28 days after vaccine Dose 1 (administered at Day 1)

• Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 2

  Measured over: Within 28 days after vaccine Dose 2 (administered at Month 2)

• Number of Participants Reporting Grade 3 Unsolicited AEs After Vaccine Dose 3

  Measured over: Within 28 days after vaccine Dose 3 (administered at Month 6)

• Number of Participants Reporting Serious Adverse Events (SAEs)

  Measured over: From first vaccination (Day 1) to study end (Month 12)

• Number of Participants in Step 1 Subset With Clinically Relevant Biochemical Abnormalities

  Measured over: At Day 7

• Number of Participants in Step 1 Subset With Clinically Relevant Hematological Abnormalities

  Measured over: At Day 7

• Number of Participants in Step 1 Subset With Clinically Relevant Abnormalities in Hemoglobin Change From Baseline Levels

  Measured over: At Day 7 compared to baseline (Day 1)

• Anti-HPV Immunoglobulin G (IgG) Antibody Concentrations

  Measured over: At Month 7 (one month after vaccine Dose 3 administration)

Changes Tremor has spotted