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

Varicella Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792623
• Other study ID #: 208133/178
• Status: Completed
• Phase: Phase 2
• Start date: September 8, 2003
• Est. completion date: September 10, 2007

Study information

• Verified date: April 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 10, 2007
• Est. primary completion date: September 10, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

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.

Exclusion Criteria:

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.

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.

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• VarilrixTM
Subcutaneous injection, 2 doses, in the deltoid region of the non-dominant upper arm.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	East Melbourne	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Primary	Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers	Antibody titers were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).	At 8 months post-transplantation = 1.5 months post-second dose of vaccination
Secondary	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.	At 6.5 months post-transplantation = 2 months post first dose of vaccination
Secondary	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.	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)
Secondary	Anti-varicella Antibody Titers	Antibody titers were were measured by Indirect Immunofluorescence Assay (IFA) and presented as geometric mean titers (GMTs).	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)
Secondary	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.	During the 8-day (Days 0-7) post-vaccination period after each dose and across doses
Secondary	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.	During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary	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).	During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary	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.	During the 43-day (Days 0-42) post-vaccination period after each dose and across doses
Secondary	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.	During the active phase of the study (up to Month 24)

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