Human Papillomavirus Vaccine Types 16 and 18 has been approved in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Human Papillomavirus Vaccine Types 16 and 18 studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
103514 (HPV-014) – 105876 (Ext HPV-014 M18) – 105880 (Ext HPV-014 M24) III Primary study (103514): A phase III, open, age-stratified study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV 16/18 L1 AS04 vaccine administered intramuscularly according to a three-dose schedule (0, 1, 6 month) in healthy female subjects aged 15 – 55 years. Extension study: A long-term, open, age-stratified follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine in healthy female subjects vaccinated in Study HPV-014. HPV: human papillomavirus
104772 (HPV-016) III A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three production lots of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 18 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured at 600L scale compared with a lower (80L) manufacturing scale. HPV: Human Papillomavirus
106001 (HPV-035) III A phase IIIb, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine, administered intramuscularly according to a 0, 1, 6 month schedule in healthy female subjects aged 18 – 35 years. HPV-16/18 L1 VLP AS04 (HPV): GSK Biologicals’ human papillomavirus (HPV) vaccine containing HPV 16/18 virus-like particles (VLPs) and adjuvant AS04.
580299/012 (HPV-012) – 107476 (Ext M18) – 107477 (Ext M24) III 580299/012 (HPV-012): A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according to a 0, 1, 6-month schedule in healthy female subjects aged 10 – 25 years and to demonstrate non-inferiority of the candidate HPV vaccine manufactured using different production processes. Extension studies: A long-term, open, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in healthy female subjects vaccinated either pre- or post-menarche in the HPV-012 study. HPV-16/18 L1/AS04 vaccine: GlaxoSmithKline Biologicals’ virus-like particle (VLP) vaccine against human papillomaviruses (HPV) 16/18
102115 II A phase I/II, double-blind, randomized, controlled study to assess the safety and immunogenicity of an investigational vaccine when administered intramuscularly according to a 3-dose schedule (0, 1, 6-month) in healthy adult females (18-25 years of age).
102115, 108052 (Ext Month 18) & 107919 (Ext Month 24) II 102115: A phase I/II, double-blind, randomized, controlled, dose-range study to assess the safety and immunogenicity of an investigational vaccine when administered intramuscularly according to a 3-dose schedule (0, 1, 6-month) in healthy adult females (18-25 years of age). 108052 (Ext Month 18) & 107919 (Ext Month 24): A long-term, open, follow-up of an investigational vaccine in healthy female subjects vaccinated in the 102115 study.
580299/007 (HPV-007) II A phase IIb, blinded, multi-center, long-term follow-up study of the efficacy of candidate HPV-16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in adolescent and young adult women in North America and Brazil vaccinated in primary study 580299/001. HPV-16/18 VLP vaccine: GlaxoSmithKline Biologicals’ virus-like particle (VLP) vaccine against human papillomaviruses (HPV) 16 and 18.
580299-001 (HPV-001) II A double-blind, placebo-controlled, randomised, pilot phase IIB study of the efficacy of an HPV-16/18 VLP vaccine in the prevention of HPV-16 and/or HPV-18 cervical infection in healthy adolescent and young adult women in North America and Brazil. HPV-16/18 L1 AS04 vaccine: GlaxoSmithKline Biologicals’ virus-like particle (VLP) vaccine against human papillomaviruses 16/18
580299-003 (HPV-003 [Mi-CP-058]) II A Phase I/II Study to evaluate the safety and immunogenicity of MEDI-517, a virus-like particle vaccine against human papillomavirus (HPV) types 16 and 18, in healthy adult female volunteers who are HPV-16 or HPV-18 DNA positive.
580299-004 (HPV-004 [Mi-CP-055]) II A Phase II Double-Blind, Randomized Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-Like Particle Vaccine Against Human Papillomavirus Types 16 and 18, When Formulated With Aluminum Hydroxide, SBAS4, or Without Adjuvant, in Healthy Adult Female Volunteers. SBAS4: GlaxoSmithKline’s (formerly SmithKline Beecham) aluminum salt and monophosphoryl lipid A adjuvant (currently known as AS04).
580299-005 (HPV-005 (Mi-CP-057)) II A Phase II Double-Blind, Randomized, Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517, a Virus-like Particle Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers. MEDI-517: GlaxoSmithKline Biologicals’ human papillomavirus (HPV)-16/18 virus-like particle (VLP) vaccine formulated with aluminum salt and monophosphoryl lipid A adjuvant (SBAS4) or with aluminum hydroxide adjuvant.
580299-002 (HPV-002 [Mi-CP-044]) I A Phase I Study of the Safety and Immunogenicity of MEDI-517, a Vaccine Against Human Papillomavirus Types 16 and 18, in Healthy Adult Female Volunteers.