Participant flow

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002) · Source last updated 2016-02-03

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

groups

1. description

   Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG000

   title

   qHPV (GARDASIL™) - Phase A Control

2. description

   Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG001

   title

   Octavalent HPV With 15 mcg IMX / AAHS

3. description

   Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG002

   title

   Octavalent HPV With 30 mcg IMX / AAHS

4. description

   Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG003

   title

   qHPV (GARDASIL™) - Phase B Control

5. description

   Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG004

   title

   Octavalent HPV With 60 mcg IMX / AAHS

6. description

   Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.

   id

   FG005

   title

   Octavalent HPV With 120 mcg IMX / AAHS

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      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

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         30

      4. group Id

         FG003

         num Subjects

         15

      5. group Id

         FG004

         num Subjects

         30

      6. group Id

         FG005

         num Subjects

         30

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         30

      3. group Id

         FG002

         num Subjects

         30

      4. group Id

         FG003

         num Subjects

         15

      5. group Id

         FG004

         num Subjects

         30

      6. group Id

         FG005

         num Subjects

         29

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Base Study (Up to 12 Months)

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      type

      Lost to Follow-up

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         1

      type

      Moved

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         19

      3. group Id

         FG002

         num Subjects

         19

      4. group Id

         FG003

         num Subjects

         7

      5. group Id

         FG004

         num Subjects

         21

      6. group Id

         FG005

         num Subjects

         15

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         14

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         19

      6. group Id

         FG005

         num Subjects

         14

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Extension Study (Up to 36 Months)

pre Assignment Details

In Phase A, participants were randomized to quadrivalent Human Papillomavirus (qHPV), Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS), or Octavalent HPV with 30 mcg IMX/AAHS. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.

recruitment Details

158 participants were enrolled. Of the enrolled 158 participants, 8 were screening failures. 150 participants were randomized to the base study (up to 12 months), conducted in 2 phases, Phase A and Phase B. Some participants continued in a voluntary, long-term extension of the study (up to 36 months).

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Preserved source evidence · Not medical advice