Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.

Conditions

Infections, Papillomavirus

Brief summary

Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule.

Tino F. Schwarz, Li‐Min Huang, Alejandra Valencia, Falko Panzer, Cheng‐Hsun Chiu et al. (12 authors)

Human Vaccines & Immunotherapeutics2019-07-0357 citations

10.1080/21645515.2019.1625644

Long-term immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in 10- to 14-year-old girls: open 6-year follow-up of an initial observer-blinded, randomized trial.

Schwarz TF, Huang LM, Lin TY, Wittermann C, Panzer F, Valencia A, Suryakiran PV, Lin L, Descamps D.

2014-12-0117 citations

10.1097/inf.0000000000000460

Results disclosure of papilloma vaccine studies in humans completed before January 1st, 2011.

Ramirez Jorge H

Figshare2014-01-01

10.6084/m9.figshare.1158703.v3

Results disclosure of papilloma vaccine studies in humans co.

Jorge Herrera Ramírez

Figshare2014-01-01

10.6084/m9.figshare.1158652.v1

Four-year follow-up of the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine when administered to adolescent girls aged 10-14 years.

Schwarz TF, Huang LM, Medina DM, Valencia A, Lin TY, Behre U, Catteau G, Thomas F, Descamps D.

2012-02-0144 citations

10.1016/j.jadohealth.2011.11.004

Interventions

BIOLOGICALHPV-16/18 L1/AS04

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

10 Years to 14 Years

Healthy volunteers

Yes

Inclusion criteria

A woman between, and including, 10 and 14 years of age at the time of the first vaccination. Written informed consent from the subject prior to enrolment. Subject must be free of obvious health problems. Subject must have negative urine pregnancy test.

Exclusion criteria

Pregnant or breastfeeding. Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality. History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease. Previous vaccination against human papillomavirus (HPV).

Design outcomes

Primary

Measure	Time frame
Demonstration of safety of the HPV vaccine compared to the control (occurrence of SAEs) up to month 7.	—

Secondary

Measure	Time frame
Safety of HPV vaccine in entire study period. Vaccine immunogenicity.	—

Countries

Australia, Colombia, Czechia, France, Germany, Honduras, Norway, Panama, South Korea, Spain, Sweden, Taiwan

Outcome results

None listed