Table 5.
Existing randomized controlled trials on human papillomavirus 9-valent vaccine
| Title | Clinical trials.gov identifier | EudraCT number | Sponsor & sponsor protocol number | Start date | Status | Published results |
|---|---|---|---|---|---|---|
| A Randomized, International, Double-Blinded (With In-House Blinding), Controlled With GARDASIL, Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26- Year-Old Women | NCT00543543 | EUCTR2007-003528-39-DK/SE/DE/AT | Merck Sharp & Dohme Corp. V503-001 |
September 2007 | Completed* | Yes [34, 38] |
| A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds) | NCT00943722 | EUCTR2009-011617-25-FI/BE/AT/SE/ES | Merck Sharp & Dohme Corp. V503-002 |
August 2009 | Active, not recruiting* | Yes [39, 42] |
| A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women | NCT01651949 | EUCTR2012-002758-22-DE/ES/FI/SE/DK | Merck Sharp & Dohme Corp. V503-003 |
October 2012 | Completed* | Yes [35] |
| An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16-to-26 Year-Olds) | – | EUCTR2015-005093-38-DE/AT/ES/BE | Sanofi Pasteur MSD GDS02C/V503-004 |
July 2016 | Ongoing† | No |
| A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) Given Concomitantly With Menactra™ and Adacel™ in Preadolescents and Adolescents (11 to 15 Year Olds) | NCT00988884 | – | Merck Sharp & Dohme Corp. V503-005 |
October 2009 | Completed* | Yes [40] |
| A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12–26 Years of Age Who Have Previously Received GARDASIL™ | NCT01047345 | EUCTR2009-015500-26-SE/DK | Merck Sharp & Dohme Corp. V503-006 |
February 2010 | Completed* | Yes [36] |
| A Phase III Open-Label Clinical Trial to Study the Immunogenicity and Tolerability of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given Concomitantly With REPEVAX™ in Preadolescents and Adolescents (11 to 15 Year Olds) | NCT01073293 | EUCTR2009-016218-26-FI/DE/BE/AT/DK | Merck Sharp & Dohme Corp. V503-007 |
April 2010 | Completed* | Yes [37] |
| A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls | NCT01254643 | – | Merck Sharp & Dohme Corp. V503-008 |
January 2011 | Completed* | No |
| A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old) | NCT01304498 | EUCTR2010-023393-39-FI/BE /SE/ES/DK/IT | Sanofi Pasteur MSD V503-009 GDS01C |
February 2011 | Completed* | Yes [43] |
| A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of a 2-dose Regimen of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Administered in Preadolescents and Adolescents (9 to 14 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds) | NCT01984697 | EUCTR2013-001314-15-CZ/NO/DK/ES | Merck Sharp & Dohme Corp. V503-010 |
December 2013 | Active, not recruiting* | No |
| A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavi–us Vaccine [HPV] [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase 3 Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus L1 Virus-Like Particle [VLP] Vaccine) in 16- to 26-year-old Men | NCT02114385 | EUCTR2013-003399-10-DE/BE/NL | Sanofi Pasteur MSD V503-020 |
March 2014 | Completed* | Yes [41] |
| A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus- Like Particle (VLP) Vaccine as Administered to 16- to 26- Year- Old Women | NCT02653118 | Merck Sharp & Dohme Corp. V503-021 |
January 2016 | Active, not recruiting* | No | |
| Immunogenicity and Safety of Gardasil-9 and Cervarix When Administered to 9–10-year-old Subjects According to 0–6 Month Schedule | NCT02567955 | – | Laval University HPV 2355 |
September 2015 | Recruiting* | No |
| A Prospective, Single-Arm, Open-Label, Non-randomized, Phase IIA Trial of a Nonavalent Prophylactic HPV Vaccine to Assess Immunogenicity of a Prime and Deferred-Booster Dosing Schedule Among 9–11 Year-Old Girls | NCT02568566 | National Cancer Institute (NCI) NCI-2015-01645 |
March 2016 | Recruiting* | No | |
| Efficacy of nonavalent vaccine against human papilloma virus (HPV) in HIV infected sexually active men who have sex with men (MSM) | – | EUCTR2015-004524-65-DK | Department of Infectious Diseases Inf.Q002 |
November 2015 | Ongoing† | No |
| A Dose Reduction Immunobridging and Safety Study of Two HPV Vaccines in Tanzanian Girls | NCT02834637 | London School of Hygiene and Tropical Medicine MITU-002 |
August 2016 | Not yet recruiting | No |
*
As reported by ClinicalTrials.gov.
†
As reported by European Union Clinical Trials Register.