Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
1 other identifier
interventional
2,007
4 countries
30
Brief Summary
In order to find the formulation leading to a maximal increase of the immune response while maintaining an acceptable safety profile, this study is designed to evaluate the immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals' influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2007
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 8, 2007
CompletedStudy Start
First participant enrolled
October 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2008
CompletedResults Posted
Study results publicly available
May 30, 2012
CompletedJune 8, 2018
October 1, 2016
8 months
October 5, 2007
April 26, 2012
May 9, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Haemagglutination Inhibition (HI) Antibody Titers
Antibody titers were expressed as Geometric mean titers (GMTs) against each of the 3 vaccine strains in greater than or equal to 65 years age groups only. The vaccine strains included A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
At Day 21
Secondary Outcomes (21)
HI Antibody Titers at Day 0 and Day 21
At Day 0 and 21
HI Antibody Titers at Day 180
At Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
At Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
At Day 180
HI Antibody Seroconversion Factors at Day 21
At Day 21
- +16 more secondary outcomes
Study Arms (10)
Influenza vaccine GSK576389A formulation 1 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 2 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 3 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 4 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 5 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 6 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 7 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Influenza vaccine GSK576389A formulation 8 Group
EXPERIMENTALSubjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
Fluarix elderly Group
ACTIVE COMPARATORSubjects aged ≥65 years received one dose of Fluarix vaccine.
Fluarix young Group
ACTIVE COMPARATORSubjects aged 18-40 years received one dose of Fluarix vaccine.
Interventions
Single dose, Intramuscular injection, 8 different formulations were tested (one per group)
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
You may not qualify if:
- 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.
- 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 a vaccine not foreseen by the study protocol during the entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007 influenza vaccine).
- Administration of more than 14 days of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Hypersensitivity to a previous dose of influenza vaccine.
- Allergy to any component of the vaccine.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature\<37.5ºC (99.5ºF).
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female or female planning to become pregnant or to discontinue contraceptive precautions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
GSK Investigational Site
Güglingen, Baden-Wurttemberg, 74363, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Rudersberg, Baden-Wurttemberg, 73635, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Rhaunen, Rhineland-Palatinate, 55624, Germany
GSK Investigational Site
Dresden, Saxony, 01067, Germany
GSK Investigational Site
Freital, Saxony, 01705, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Wolmirstedt, Saxony-Anhalt, 39326, Germany
GSK Investigational Site
Berlin, 10435, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Berlin, 13359, Germany
GSK Investigational Site
Hamburg, 22335, Germany
GSK Investigational Site
Hamburg, 22415, Germany
GSK Investigational Site
Rotterdam, 3011 EN, Netherlands
GSK Investigational Site
Rotterdam, 3015 GE, Netherlands
GSK Investigational Site
Eskilstuna, SE-631 88, Sweden
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Reading, Berkshire, RG2 0TG, United Kingdom
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom
GSK Investigational Site
Clydebank, Glasgow, G81 2DR, United Kingdom
GSK Investigational Site
Edgbaston, Birmingham, B15 2SQ, United Kingdom
GSK Investigational Site
Waterloo, Liverpool, L22 0LG, United Kingdom
Related Publications (1)
Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.
PMID: 23890405DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2007
First Posted
October 8, 2007
Study Start
October 8, 2007
Primary Completion
June 10, 2008
Study Completion
June 10, 2008
Last Updated
June 8, 2018
Results First Posted
May 30, 2012
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.