VaricellaPhase 2NCT00792623

Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

A Phase 2 study testing VarilrixTM in people with Varicella, run by GlaxoSmithKline at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Varicella
What is being tested?: VarilrixTM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 3 sitesAustralia
Study dates: 8 Sep 2003to 10 Sep 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Screening phase:
A male or female ≥ 18 years of age at the time of study entry.
Written informed consent obtained from the subject prior to study entry.
Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
Subjects who the investigator believes can and will comply with the requirements of the protocol
If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

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Active phase:
Patients who are confirmed to have undergone autologous peripheral stem cell/ bone marrow transplantation.
If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Who cannot join

Screening phase:
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
History of allergy to any component of the vaccine.
Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
Current drug and/or alcohol abuse.

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Active phase:
Use of any investigational or non-registered product (drug or vaccine) during the active phase of the study period.
Use of immunosuppressants or other immune-modifying drugs within 14 days preceding the administration of the first dose of the study vaccine or planned use during the active phase of the study period.
Use of rituximab (MabThera) more than 60 days after transplant.
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
History of allergy to any component of the vaccine
Patients with VZV disease after transplantation and prior to vaccination.
Ongoing requirement for antiviral therapy with anti-VZV activity beyond 4 months post-transplantation
Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
Current drug and/or alcohol abuse.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

GSK Investigational Site
East Melbourne, Victoria, 3002
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Melbourne, Victoria, 3050

Other trials in Australia

About this study

Official title: A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given as a Primary Vaccination at 4.5 Months and 6.5 Months Post-transplantation, in Autologous Stem Cell/ Bone Marrow Transplant Recipients Aged 18 Years and Older.

Conditions: Varicella
Being tested: VarilrixTM
Keywords: Varicella, VarilrixTM
Medical subject headings: Chickenpox

What participants receive

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

VarilrixTMBiological
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

Study groups in NCT00792623
Study group	Role	What they receive
Varilrix Group	Experimental	Subjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation. Receives: Biological: VarilrixTM

What is being measured

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

Number of Subjects With a Varicella Vaccine Response
Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.
Measured: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Measured: At 8 months post-transplantation = 1.5 months post-second dose of vaccination

Secondary outcomes (8)

Number of Subjects With a Varicella Vaccine Response
Vaccine response was defined as: for initially seropositive subjects, antibody titer at 6.5 months post-transplantation ≥ 4 fold the pre-vaccination antibody titer.
Measured: At 6.5 months post-transplantation = 2 months post first dose of vaccination
Number of Seropositive Subjects for Anti-varicella Antibodies
The seropositivity cut-off titer of the assay was an anti-VZV antibody titer greater than or equal to (≥) 1:4.
Measured: At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)
Anti-varicella Antibody Titers
Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).
Measured: At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Number of Subjects With Any Fever
Any = fever equal to or greater than (≥) 37.5 °C. Grade 3 fever = fever above (>) 39.0 °C. Related = fever assessed by the investigator as related to the vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any and Related Rash
Rash was assessed as being either associated to the administration site or not. Non administration site rash was presented by following characteristics (with fever, measles/rubella like, varicella like and related).
Measured: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the active phase of the study (up to Month 24)

Timeline

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

8 Sep 200310 Sep 2007

First posted18 Nov 2008 (estimated)
Study start8 Sep 2003
Primary completion10 Sep 2007
Study completion10 Sep 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for VaricellaStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00792623
Sponsor's protocol ID: 208133/178
Status last verified: Apr 2017
First submitted: 17 Nov 2008
Last updated: 8 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Sasadeusz J, Prince HM, Schwarer A, Szer J, Stork A, Bock HL, Povey M, Nicholson O, Innis BL. Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis. 2014 Dec;16(6):1024-31. doi: 10.1111/tid.12295. Epub 2014 Oct 1.
PubMed 25272081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Varicella trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given as a Primary Vaccination at 4.5 Months and 6.5 Months Post-transplantation, in Autologous Stem Cell/ Bone Marrow Transplant Recipients Aged 18 Years and Older.
ClinicalTrials.gov ID: NCT00792623
Acronym / sponsor ID: 208133/178
Conditions: Varicella
Keywords: Varicella, VarilrixTM
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 8 Sep 2003 (actual)
Primary completion: 10 Sep 2007 (actual)
Study completion: 10 Sep 2007 (actual)
First posted: 18 Nov 2008 (estimated)
Results: Posted 6 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Varilrix Group	Experimental	Biological: VarilrixTMSubjects with autologous peripheral stem cell/bone marrow transplants, who received 2 doses of Varilrix vaccine subcutaneously in the deltiod region of the non-dominant upper arm, at 4.5 and 6.5 months post-transplantation.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

A male or female ≥ 18 years of age at the time of study entry.
Written informed consent obtained from the subject prior to study entry.
Patients who are planned to undergo autologous peripheral stem cell/ bone marrow transplantation.
Subjects who the investigator believes can and will comply with the requirements of the protocol
If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for 10 months after transplantation.

Key exclusion criteria (18 listed)

Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions in the 10 months post-transplantation.
History of allergy to any component of the vaccine.
Patients with difficult to treat disease who are likely to relapse within 6 months post-transplantation.
Current drug and/or alcohol abuse.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VarilrixTMSubcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.	Biological	Varilrix Group

Primary outcome

Number of Subjects With a Varicella Vaccine Response
Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Vaccine response was defined as: for initially seropositive subjects, an antibody titer at Month 8 post-transplantation above or equal to (≥) 4 fold the pre-vaccination antibody titer.
Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers
Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).

8 secondary outcomes

Number of Subjects With a Varicella Vaccine Response
Time frame: At 6.5 months post-transplantation = 2 months post first dose of vaccination
Number of Seropositive Subjects for Anti-varicella Antibodies
Time frame: At pre-transplantation (Month 0), pre-vaccination visit (at 4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 months post-second dose of vaccination)
Anti-varicella Antibody Titers
Time frame: At pre-transplantation (Month 0), pre-vaccination visit (4.5 months post-transplantation), Month 12 and Month 24 (5.5 and 17.5 post-second dose of vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Time frame: During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Number of Subjects With Any Fever
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any and Related Rash
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the active phase of the study (up to Month 24)

Results and safety

Results posted to the registry on 6 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varilrix Group	29	22

Primary outcome: Number of Subjects With a Varicella Vaccine Response

Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination. Count of participants. Unit: Participants

Measure	Varilrix Group n = 15
Value	1

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-varicella zoster virus (VZV) antibodies for Month 8 time point were available.

Primary outcome: Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers

Time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Varilrix Group n = 15
Value	707.5 (308.0 to 1625.5)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity measures and assay results for anti-VZV antibodies for Month 8 time point were available.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: during the 8-day (Days 0-7) post-vaccination period; Unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period; Serious adverse events (SAEs): during the entire study, up to Month 24 post-transplantation.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varilrix Group	5 of 29 (17.2%)	14 of 29 (48.3%)	1 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25272081Sasadeusz J, Prince HM, Schwarer A, Szer J, Stork A, Bock HL, Povey M, Nicholson O, Innis BL. Immunogenicity and safety of a two-dose live attenuated varicella vaccine given to adults following autologous hematopoietic stem cell transplantation. Transpl Infect Dis. 2014 Dec;16(6):1024-31. doi: 10.1111/tid.12295. Epub 2014 Oct 1.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VarilrixTM in people with Varicella, run by GlaxoSmithKline at 3 sites in Australia.

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: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With a Varicella Vaccine Response (time frame: At 8 months post-transplantation = 1.5 months post-second dose of vaccination). The study lists 2 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 NCT00792623, which also lists 1 linked publication.

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 8 Nov 2018.