H1N1sw Vaccine in Adult Transplant Recipients

A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069601

Enrollment

Registered

2010-02-17

Start date

2010-02-28

Completion date

2012-04-30

Last updated

2012-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunocompromised

Keywords

solid organ transplantation, bone marrow transplantation, adults, adults with solid organ transplantation, adults with bone marrow transplantation

Brief summary

The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Interventions

BIOLOGICALFocetria (2x H1N1 vaccine with MF59 adjuvants)

7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment * Patients able to visit the outpatient clinic with a life expectancy of at least one year * Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Exclusion criteria

* Individuals who received any vaccine within 30 days prior to study entry * Individuals who received a H1N1 vaccination less than 6 months prior to the study * Influenza diagnosed by a physician within 4 months prior to the study start * Pregnant or lactating females * History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)

Design outcomes

Primary

Measure	Time frame
The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.	42 days

Secondary

Measure	Time frame
The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration.	42 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026