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Quadrivalent HPV L1 VLP Vaccine 20/40/40/20 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Placebo (mcg) (Aluminum Adjuvant) 225 | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6. |
| Placebo (mcg) (Aluminum Adjuvant) 450 | EXPERIMENTAL | The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 | BIOLOGICAL | 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40 | BIOLOGICAL | 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80 | BIOLOGICAL | 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6. |
| Placebo (mcg) (Aluminum Adjuvant)225 | BIOLOGICAL | placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6. |
| Placebo (mcg) (Aluminum Adjuvant) 450 | BIOLOGICAL | placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6. |
Inclusion Criteria: * Healthy females 16 to 23 years of age * Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study * Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred) Exclusion Crit...
Quadrivalent HPV L1 VLP Vaccine 20/40/40/20 is an investigational vaccine developed by Merck & Company, Inc. (MRK) for papillomavirus infections. It is a virus-like particle vaccine designed to cover four HPV types, and it has been studied in a Phase 2 dose-ranging trial in female participants.
Quadrivalent HPV L1 VLP Vaccine 20/40/40/20 is being studied for papillomavirus infections, including genital diseases in women. The Phase 2 program enrolled healthy female volunteers aged 16 years and older. It remains an investigational vaccine and is not an approved product.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of Quadrivalent HPV L1 VLP Vaccine 20/40/40/20. The company sponsored the Phase 2 dose-ranging study of the vaccine in papillomavirus infections.
Quadrivalent HPV L1 VLP Vaccine 20/40/40/20 is in Phase 2 development. Its single registered trial, NCT00365716, is a completed Phase 2 dose-ranging study. The vaccine is investigational and has not been approved for marketing.
Quadrivalent HPV L1 VLP Vaccine 20/40/40/20 has been evaluated in one clinical trial, NCT00365716, titled a dose-ranging study of quadrivalent HPV types 6, 11, 16 and 18 L1 virus-like particle vaccine. That Phase 2 trial is completed and enrolled 1,158 participants.