Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Communicable Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

All Drugs and Chemicals

Vaccines

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-High formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Medium formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the HPV9-Low formulation of the investigational adjuvanted HPV vaccine on Day 1, Month 2, and Month 6.

Healthy females aged 16 to 26 years receive 3 doses of the marketed HPV vaccine on Day 1, Month 2, and Month 6.

3 doses of a high formulation investigational adjuvanted HPV9 vaccine intramuscularly (IM) on Day 1, Month 2, and Month 6.

HPV9 High formulation

3 doses of a medium formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.

HPV9 Medium formulation

3 doses of a low formulation investigational adjuvanted HPV9 vaccine administered IM on Day 1, Month 2, and Month 6.

HPV9 Low formulation

3 doses of the marketed HPV vaccine (Gradasil 9) administered IM on Day 1, Month 2, and Month 6.

Gardasil 9

The Main purpose of this study is to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)'s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

Observer-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine

Only female participants, between 16-26 years of age are included in the study.

A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

A Phase 1/2 Randomized, Observer-blinded, Multi-country Study to Evaluate Safety and Immunogenicity of Investigational Adjuvanted Human Papillomavirus Vaccine in Females (16 to 26 Years of Age)

IPD for this study will be made available via the Clinical Study Data Request site.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in millimeters (mm) which is more than (\>) 50 mm.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in (mm) which is \>50 mm.

Solicited administration site events include pain, redness, and swelling. Grade 3 pain is defined as significant pain at rest which prevents normal everyday activity. Grade 3 redness and swelling are defined as the greatest surface diameter in mm which is \>50 mm.

Solicited systemic events include fever, headache, fatigue, myalgia, and arthralgia. Grade 3 fever is defined as temperature \>39.0 degrees Celsius (°C) or 102.2 Fahrenheit (°F). Grade 3 headache, fatigue, myalgia and arthralgia are defined as severe events that prevent normal activity.

Solicited systemic events include fever, headache, fatigue, myalgia, and arthralgia. Grade 3 fever is defined as temperature \>39.0°C or 102.2°F. Grade 3 headache, fatigue, myalgia and arthralgia are defined as severe events that prevent normal activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/ Legally acceptable representative(s) (LAR(s)) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/ participant's parent(s)/ LAR(s) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent. Grade 3 unsolicited AEs is an AE which prevents normal, everyday activity.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes, or other situations judged by the investigator as fitting the definition of a SAE.

Clinically relevant abnormalities for each biochemical and hematological parameter are defined as parameters outside the defined normal ranges for each parameter and are assessed after the first vaccine dose administered.

Solicited administration site events include pain, redness, and swelling.

Solicited systemic events include fever, headache, myalgia, arthralgia, and fatigue.

An unsolicited AE is an AE that was not included in the list of solicited using an eDiary and that was spontaneously communicated by a participant/participant's parent(s)/LAR(s) who has signed the informed consent.

pIMDs include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Seroconversion is defined as the appearance of antibodies (i.e., concentrations greater than or equal to the cut-off value) in the serum of participants seronegative before vaccination.

Seroconversion is defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of participants seronegative before vaccination.

Pearson coefficient is calculated for correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers.

Spots Global Cancer Trial Database for A Study on the Immune Response and Safety of an Adjuvanted Human Papillomavirus Vaccine When Given to Healthy Women 16 to 26 Years of Age

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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