Human Papilloma Virus Vaccine Consistency and Non-inferiority Trial in Young Adult 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 consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start. Approximately 750 study subjects will receive different lots of the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Matti Lehtinen, Penelope Gray, Tapio Luostarinen, Tiina Eriksson, Dan Apter et al. (18 authors)

Frontiers in Cellular and Infection Microbiology2024-09-093 citations

10.3389/fcimb.2024.1437704

Human papillomavirus vaccine efficacy against invasive, HPV-positive cancers: population-based follow-up of a cluster-randomised trial

Matti Lehtinen, Camilla Lagheden, Tapio Luostarinen, Tiina Eriksson, Dan Apter et al. (21 authors)

BMJ Open2021-12-0143 citations

10.1136/bmjopen-2021-050669

Ten-year follow-up of human papillomavirus vaccine efficacy against the most stringent cervical neoplasia end-point—registry-based follow-up of <i>three cohorts from randomized trials</i>

Matti Lehtinen, Camilla Lagheden, Tapio Luostarinen, Tiina Eriksson, Dan Apter et al. (17 authors)

BMJ Open2017-08-0188 citations

10.1136/bmjopen-2017-015867

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

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 25 Years

Healthy volunteers

Yes

Inclusion criteria

* A woman between, and including, 10 and 25 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 lot-to-lot consistency in terms of immunogenicity of 3 lots of HPV-16/18 vaccine.	—
Demonstration of non-inferiority in terms of immunogenicity of the HPV vaccine produced with a revised manufacturing process compared to the HPV vaccine produced with a previous manufacturing process	—

Secondary

Measure	Time frame
Safety of HPV vaccine in entire study period. Immunogenicity bridge between pre-adolescent and adolescent population.	—

Countries

Denmark, Estonia, Finland, Greece, Netherlands, Russia

Outcome results

None listed