Phase 2
N=29
Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).
Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00792623 ↗Enrolled (actual)
29
Serious AEs
17.2%
Results posted
Jul 2017
Primary outcome: Primary: Number of Subjects With a Varicella Vaccine Response — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VarilrixTM (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a Varicella Vaccine Response |
2 | — |
| PRIMARY Anti-varicella Zoster Virus (Anti-VZV) Antibody Titers |
707.5 | — |
| SECONDARY Number of Subjects With a Varicella Vaccine Response |
2 | — |
| SECONDARY Number of Seropositive Subjects for Anti-varicella Antibodies |
15; 15; 14; 13 | — |
| SECONDARY Anti-varicella Antibody Titers |
1024.0; 645.1; 380.4; 284.8 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Adverse Events |
5; 0; 4; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any Fever |
3; 0; 0; 6; 0; 2 | — |
| SECONDARY Number of Subjects With Any and Related Rash |
3; 0; 3; 2; 0; 1 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
11 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00792623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.