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

GlaxoSmithKline0 sitesFebruary 2015

ConditionsInfections, Papillomavirus

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Papillomavirus
Sponsor: GlaxoSmithKline
Primary Endpoint: Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group
Status: Withdrawn
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 2015

End Date

November 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group

Time Frame: One month after the second dose (Month 7)

Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group

Time Frame: One month after the second dose (Month 7)

Anti-HAV seroconversion status in the HPV+HAV group and the HAV group

Time Frame: One month after the second dose (Month 7)

Anti-HAV antibody titres in the HPV+HAV group and the HAV group

Time Frame: One month after the second dose (Month 7)

Secondary Outcomes

Anti-HPV-16/18 seroconversion status in the HPV group and the HPV+HAV group(One month after the second dose (Month 7))
Anti-HPV-16/18 antibody titres in the HPV group and the HPV+HAV group(One month after the second dose (Month 7))
Anti-HAV seroconversion status in the HPV+HAV group and the HAV group(One month after the second dose (Month 7))
Anti-HAV antibody titres in the HPV+HAV group and the HAV group(One month after the second dose (Month 7))
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)
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)
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)
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))
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))
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))
Occurrence of pregnancies and pregnancy outcomes(During the entire study period (Month 0 - Month 12))