Participant flow

A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006) · Source last updated 2018-11-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.

   id

   FG000

   title

   9vHPV Vaccine - Base Study

2. description

   Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.

   id

   FG001

   title

   Placebo - Base Study

3. description

   Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.

   id

   FG002

   title

   9vHPV Vaccine - Extension Study

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   4. reasons

      1. group Id

         FG000

         num Subjects

         12

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         618

      2. group Id

         FG001

         num Subjects

         306

      3. group Id

         FG002

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         615

      2. group Id

         FG001

         num Subjects

         306

      3. group Id

         FG002

         num Subjects

         0

      type

      Vaccination 1

   3. achievements

      1. group Id

         FG000

         num Subjects

         604

      2. group Id

         FG001

         num Subjects

         304

      3. group Id

         FG002

         num Subjects

         0

      type

      Vaccination 2

   4. achievements

      1. group Id

         FG000

         num Subjects

         597

      2. group Id

         FG001

         num Subjects

         300

      3. group Id

         FG002

         num Subjects

         0

      type

      Vaccination 3

   5. achievements

      1. comment

         Includes 1 participant for whom completion status is unknown

         group Id

         FG000

         num Subjects

         596

      2. group Id

         FG001

         num Subjects

         300

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Base Study

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         5

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. comment

         Not all eligible participants elected to participate in extension

         group Id

         FG002

         num Subjects

         102

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         102

      type

      Vaccination 4

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         99

      type

      Vaccination 5

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. comment

         1 participant received 6th vaccination outside the context of study but completed the study.

         group Id

         FG002

         num Subjects

         95

      type

      Vaccination 6

   5. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         96

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         6

      type

      NOT COMPLETED

   title

   Extension

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Preserved source evidence · Not medical advice