NCT00092482

Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Completed Phase 3 Last updated 22 March 2017

What this trial tests

Phase 3 trial testing V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years in Cervical Cancer in 3,882 participants. Completed in 15 August 2008.

Timeline

28 June 2002

Primary endpoint
30 June 2004

15 August 2008

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	3,882
Start date	28 June 2002
Primary completion	30 June 2004
Estimated completion	15 August 2008

Drugs / interventions tested

• V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Genital Warts — all drugs for Genital Warts →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 16 to 23, female only, with Cervical Cancer or Genital Warts. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years.
   Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, et al · · 2009 · cited 417× · PMID 19236279 · DOI 10.1086/597307
2. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors.
   Arbyn M, Xu L, Simoens C, Martin-Hirsch PP. · · 2018 · cited 289× · PMID 29740819 · DOI 10.1002/14651858.cd009069.pub3
3. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years.
   Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, et al · · 2009 · cited 191× · PMID 19236277 · DOI 10.1086/597309
4. Virus-like particle vaccinology, from bench to bedside.
   Mohsen MO, Bachmann MF. · · 2022 · cited 181× · PMID 35962190 · DOI 10.1038/s41423-022-00897-8
5. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines.
   Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, et al · · 2007 · cited 24× · PMID 17428949 · DOI 10.1128/cvi.00478-06
6. Targeting lymph node delivery with nanovaccines for cancer immunotherapy: recent advances and future directions.
   Li Y, Li S, Jiang Z, Tan K, et al · · 2023 · cited 21× · PMID 37415161 · DOI 10.1186/s12951-023-01977-1
7. Comparative Effects of Bivalent, Quadrivalent, and Nonavalent Human Papillomavirus Vaccines in The Prevention of Genotype-Specific Infection: A Systematic Review and Network Meta-Analysis.
   Kim J, Choe YJ, Park J, Cho J, et al · · 2024 · cited 8× · PMID 38014729 · DOI 10.3947/ic.2023.0064
8. Human papillomavirus seroprevalence and seroconversion following baseline detection of nine human papillomavirus types in young women.
   Brown DR, Castellsagué X, Ferris D, Garland SM, et al · · 2022 · cited 7× · PMID 35525430 · DOI 10.1016/j.tvr.2022.200236