Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus Vaccine (Cervarix™) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) in Healthy Female Adolescents Aged 9-14 Years

Infections, Papillomavirus Clinical Trial

Official title:

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix™) (GSK-580299) When Co-administered With GSK Biologicals' Hepatitis A Vaccine (Havrix®) (GSK-208109) in Healthy Female Adolescents Aged 9-14 Years

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02082639
• Other study ID #: 117099
• Secondary ID: 2012-004378-24
• Status: Withdrawn
• Phase: Phase 3
• First received: March 6, 2014
• Last updated: July 16, 2015
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the immunogenicity and safety of two doses of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine when co-administered with GSK Biologicals' HAV vaccine according to 0, 6 month schedule, compared to the administration of either of these vaccines alone. The study will ascertain that the immune responses elicited to the two vaccines are not adversely impacted compared to when HPV-16/18 L1 VLP AS04 vaccine and HAV vaccine are administered alone.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

• A female between, and including, 9 and 14 years of age at the time of the first vaccination.

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrollment.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

• Female subjects of non-childbearing potential may be enrolled in the study.

• Female subjects of childbearing potential may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of vaccination, and

• has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

Exclusion Criteria:

• Child in care.

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed.

• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and 30 days after the first dose of vaccine with the exception of routine vaccines such as meningococcal, pertussis, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine.

• Concurrently participating in another clinical study, at any time during the study period (up to Month 12), in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.

• Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (up to Month 12).

• Previous administration of MPL or AS04 adjuvant.

• Previous vaccination against hepatitis A or planned administration of any hepatitis A vaccine other than that foreseen by the study protocol during the study period (up to Month 12).

• Cancer or autoimmune disease under treatment.

• History of hepatitis A infection.

• Known exposure to hepatitis A within the previous 6 weeks.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• Hypersensitivity to latex.

• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator preclude administration of the study vaccine.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period (up to Month 12).

• Acute disease and/or fever at the time of enrollment.

• Fever is defined as temperature = 37.0°C for oral, axillary or tympanic route. The preferred route for recording temperature in this study will be oral or axillary.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Infections, Papillomavirus

Intervention

Biological:
• Cervarix™
2 doses intramuscularly in the deltoid muscle of the non-dominant arm
• Havrix
2 doses intramuscularly in the deltoid muscle of the dominant arm

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group		One month after the second dose (Month 7)	No
Primary	Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group		One month after the second dose (Month 7)	No
Primary	Anti-HAV seroconversion status in the HPV+HAV group and the HAV group		One month after the second dose (Month 7)	No
Primary	Anti-HAV antibody titres in the HPV+HAV group and the HAV group		One month after the second dose (Month 7)	No
Secondary	Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group		One month after the second dose (Month 7)	No
Secondary	Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group		One month after the second dose (Month 7)	No
Secondary	Anti-HAV seroconversion status in the HPV+HAV group and the HAV group		One month after the second dose (Month 7)	No
Secondary	Anti-HAV antibody titres in the HPV+HAV group and the HAV group		One month after the second dose (Month 7)	No
Secondary	Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups		During the 7-day period (Day 0-6) following each vaccination	No
Secondary	Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups		During the 7-day period (Day 0-6) following each vaccination	No
Secondary	Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups		During the 30-day period (Day 0-29) following any vaccination	No
Secondary	Occurrence of any and causally related to vaccination serious adverse events (SAEs) in all groups		Throughout the active phase of the study (up to Month 7) and during the extended safety follow-up period (up to Month 12)	No
Secondary	Occurrence of medically significant conditions (MSCs) in all groups		Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)	No
Secondary	Occurrence of potential immune-mediated diseases (pIMDs) in all groups		Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)	No
Secondary	Occurrence of pregnancies and pregnancy outcomes		During the entire study period (Month 0 - Month 12)	No