CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
AS03-adjuvanted H1N1 pandemic influenza vaccinebiological
Likely dose
AS03-adjuvanted H1N1 pandemic influenza vaccine 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01016548
NCT01016548Phase 3Completed
CompareCT.gov

Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation

University Health Network, Toronto·interventional·Posted Nov 19, 2009·Updated Jun 4, 2010

In Brief

A Phase 3 clinical trial evaluating AS03-adjuvanted H1N1 pandemic influenza vaccine for Lymphoma and 2 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Multiple Myeloma, Influenza A Virus, H1N1 Subtype
CountriesCanada
CollaboratorsPrincess Margaret Hospital, Canada

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2009
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.6 years ago

Interventions

AS03-adjuvanted H1N1 pandemic influenza vaccinebiological

One dose constitutes 0.5mL of suspended vaccine via the intramuscular route.