AzTrials
AzTrials

Infections, PapillomavirusPhase 3NCT02082639

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

A Phase 3 study testing Cervarix™ and Havrix in people with Infections, Papillomavirus, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 9 to 14 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infections, Papillomavirus
What is being tested?
Cervarix™ and Havrix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2015to Nov 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 14 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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.

Who cannot join

  • 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).
Show all 18Show fewer
  • 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.

About this study

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

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.

Being tested
Cervarix™, Havrix
Keywords
Adolescents, Havrix, Immunogenicity, Cervarix, Safety
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervarix™Biological

    2 doses intramuscularly in the deltoid muscle of the non-dominant arm

  • HavrixBiological

    2 doses intramuscularly in the deltoid muscle of the dominant arm

Study groups in NCT02082639
Study groupRoleWhat they receive
HPV GroupExperimentalSubjects will receive two doses of HPV vaccine intramuscularly
Receives: Biological: Cervarix™
HAV GroupExperimentalSubjects will receive two doses of HAV vaccine intramuscularly
Receives: Biological: Havrix
HPV+HAV GroupExperimentalSubjects will receive two doses of both HPV and HAV vaccines intramuscularly
Receives: Biological: Cervarix™; Biological: Havrix

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

Secondary outcomes (11)

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

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

    Measured: One month after the second dose (Month 7)

  5. Occurrence of any and Grade 3 solicited local symptoms (injection site pain, redness and swelling) in all study groups

    Measured: During the 7-day period (Day 0-6) following each vaccination

  6. Occurrence of any, Grade 3 and causally related to vaccination solicited general symptoms in all study groups

    Measured: During the 7-day period (Day 0-6) following each vaccination

  7. Occurrence of any, Grade 3 and causally related to vaccination unsolicited AEs in all study groups

    Measured: During the 30-day period (Day 0-29) following any vaccination

  8. Occurrence of any and causally related to vaccination serious adverse events (SAEs) in all groups

    Measured: Throughout the active phase of the study (up to Month 7) and during the extended safety follow-up period (up to Month 12)

  9. Occurrence of medically significant conditions (MSCs) in all groups

    Measured: Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)

  10. Occurrence of potential immune-mediated diseases (pIMDs) in all groups

    Measured: Throughout the active phase (up to Month 7) and during the extended safety follow-up period (up to Month 12)

  11. Occurrence of pregnancies and pregnancy outcomes

    Measured: During the entire study period (Month 0 - Month 12)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionAug 2015 (estimated)
  4. Study completionNov 2015 (estimated)

Why it stopped: Because the Russian Authorities already approved the 2-dose Cervarix™ schedule, the study was no longer needed for registration and hence it was cancelled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02082639
Sponsor's protocol ID
117099
Other IDs
2012-004378-24
Status last verified
Jul 2015
First submitted
6 Mar 2014
Last updated
20 Jul 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cervarix™ and Havrix in people with Infections, Papillomavirus, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02082639.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in