Primary objective is to assess the safety and reactogenicity during the entire study period in subjects aged 66 years (previously enrolled in the FLU NG-036 EXT 025 Y1 study) vaccinated with the FLU NG vaccine or with Fluarix*, and in subjects aged…
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Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Solicited local and general symptoms:
-Occurrence, intensity and duration of solicited local AEs during a 7-day
follow-up period (i.e. day of vaccination and 6 subsequent days) after
vaccination.
-Occurrence, intensity, duration and relationship to vaccination of solicited
general AEs during a 7-day follow-up period (i.e. day of vaccination and 6
subsequent days) after vaccination.
•Unsolicited adverse events:
-Occurrence, intensity and relationship to vaccination of unsolicited AEs
during a 21-day follow-up period (i.e. day of vaccination and 20 subsequent
days) after vaccination.
•Predefined adverse events:
-Occurrence, intensity and relationship to vaccination of AEs with medically
attended visit during a 180-day follow-up period (i.e. day of vaccination and
179 subsequent days) after vaccination.
-Occurrence, intensity and relationship to vaccination of AEs of specific
interest during the entire study period.
•Serious adverse events:
-Occurrence and relationship to vaccination of SAEs during the entire study
period.
Secondary outcome
•Humoral immune response in terms of Haemagglutination Inhibition (HI)
antibodies at days 0, 21 and 180.
•Cell-mediated immune (CMI) response at days 0, 21 and 180.
Background summary
The GlaxoSmithKline Biologicals' strategy to develop an improved influenza
vaccine is to use adjuvants to enhance the reduced immunological responses to
influenza vaccines in the elderly adults and to do so without compromising
vaccine safety. FLU NG vaccine is the final selected formulation of GSK
Biologicals* adjuvanted influenza vaccine based on the results of the
FLU-AS25-025 PRI study.
Since influenza vaccines are administered every year because of the frequent
change in their antigenic composition, the safety and immunogenicity profile of
the FLU NG vaccine will be evaluated after repeated vaccination.
In the FLU NG-036 EXT 025 Y1 study, subjects previously enrolled in two
specific candidate vaccine groups in the FLU-AS25-025 PRI study were
revaccinated with the FLU NG vaccine. Fluarix* was used as a reference.
In this study, subjects of the two specific candidate vaccine groups will be
revaccinated for the second time with the FLU NG vaccine and Fluarix* will be
used as a reference.
Study objective
Primary objective is to assess the safety and reactogenicity during the entire
study period in subjects aged 66 years (previously enrolled in the FLU NG-036
EXT 025 Y1 study) vaccinated with the FLU NG vaccine or with Fluarix*, and in
subjects aged 19-43 years (previously enrolled in the FLU NG-036 EXT 025 Y1
study) vaccinated with Fluarix*.
Study design
A phase III, observer-blind, multicountry, multicentre study conducted in three
countries recruiting a maximum of 526 subjects. Subjects will receive the same
vaccine as during the previous study, either FLU NG or Fluarix*. The treatment
is observer blind for subjects aged 66 years or older and open for subjects
aged 19-43 years.
Duration of the study is six months. The vaccination schedule is one
intramuscular injection at day 0. Bloodsamples will be collected at three
visits, day 0, day 21 and day 180. A phone contact is scheduled at day 90.
Intervention
Intramuscular injection of the study vaccine or comparator at day 0.
Study burden and risks
Fluarix* may cause adverse events such as local reactions and mild general
symptoms. FLU NG may cause the same adverse events, however the reactogenicity
of FLU NG has shown to be higher when compared to Fluarix. Results from
previous studies show that FLU NG has an acceptable safety profile and is well
tolerated by subjects aged 65 years and older. Risks related to FLU NG
vaccination may partially be unknown. Risks related to the blood drawing
procedures are low and considered to be acceptable.
All subjects will receive an active vaccine and will benefit from partial
protection against flu.
Huis ter Heideweg 62
3705 LZ Zeist
Nederland
Huis ter Heideweg 62
3705 LZ Zeist
Nederland
Listed location countries
Age
Inclusion criteria
1. Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, reporting by phone) should be enrolled in the study.
2. A male or female aged 19-43 years or *66 years at the time of the vaccination and who participated in the 111737 study and completed the 6-month follow-up.
3. Written informed consent obtained from the subject.
4. Free of an acute aggravation of the health status as established by clinical evaluation (medical history and physical examination) before entering into the study.
5. Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study if the subject:
•has practiced adequate contraception for 30 days prior to vaccination, and
•has a negative pregnancy test on the day of vaccination, and
•has agreed to continue adequate contraception for 2 months after the vaccination.
Exclusion criteria
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
2. Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
3. Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
4. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. (For corticosteroids, this will mean prednisone, or equivalent, *20 mg/day. Inhaled and topical steroids are allowed.)
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6. History of hypersensivity to a previous dose of influenza vaccine.
7. History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
8. Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation (medical history and physical examination) or pre-existing laboratory screening tests.
9. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature >=37.5°C on oral setting. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
10. Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
11. Any medical conditions in which IM injections are contraindicated
12. Pregnant or lactating female.
13. Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012188-32-NL |
| CCMO | NL28615.000.09 |