Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

Influenza Clinical Trial

Official title:

Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321763
• Other study ID #: 107192
• Secondary ID: 107214
• Status: Completed
• Phase: Phase 2
• Start date: April 27, 2006
• Est. completion date: July 7, 2006

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Description:

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3124
• Est. completion date: July 7, 2006
• Est. primary completion date: July 1, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• A male or female age 60 years or older at the time of the vaccination.

• Subjects who the investigator believes can and will comply with the requirements of the protocol

• Written informed consent obtained from the subject.

• Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

• Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.

• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 up to 30 days after vaccination.

• History of hypersensitivity to a previous dose of influenza vaccine.

• History of confirmed influenza infection within the last 12 months.

• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)

• Acute disease at the time of enrolment

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
• Fluarix TM
Single dose, Intramuscular injection

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Caen cedex 4
France	GSK Investigational Site	Gières
France	GSK Investigational Site	Lagord
France	GSK Investigational Site	Lille
France	GSK Investigational Site	Montpellier Cedex 5
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Poitiers
France	GSK Investigational Site	Rouen
France	GSK Investigational Site	Toulouse
Germany	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern
Germany	GSK Investigational Site	Kamenz	Sachsen
Germany	GSK Investigational Site	Ketzin	Brandenburg
Germany	GSK Investigational Site	Koenigslutter	Niedersachsen
Germany	GSK Investigational Site	Marktl	Bayern
Germany	GSK Investigational Site	Oberaudorf	Bayern
Germany	GSK Investigational Site	Pirna	Sachsen
Germany	GSK Investigational Site	Tostedt	Niedersachsen
Germany	GSK Investigational Site	Weissenberg	Sachsen
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Goudi / Athens
Greece	GSK Investigational Site	Haidari
Greece	GSK Investigational Site	Marousi
Greece	GSK Investigational Site	Nikaia Piraeus
Greece	GSK Investigational Site	Orestiada
Greece	GSK Investigational Site	Papagos/Athens
Greece	GSK Investigational Site	Thessaloniki
Norway	GSK Investigational Site	Elverum
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Paradis
Norway	GSK Investigational Site	Stavanger
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Kazan
Russian Federation	GSK Investigational Site	Saratov
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Cardiff	Glamorgan
United Kingdom	GSK Investigational Site	Edgbaston, Birmingham
United Kingdom	GSK Investigational Site	Glasgow	Lanarkshire
United Kingdom	GSK Investigational Site	Manchester
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Waterloo, Liverpool

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Estonia,  France,  Germany,  Greece,  Norway,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.	Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.	At Days 0 and 21
Primary	Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer =1:40 or a pre-vaccination titer =1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.	At Day 21
Primary	Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.	A seroprotected subject was defined as a vaccinated subject who had a serum HI titer = 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.	At Days 0 and 21
Primary	Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.	The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.	At Day 21
Primary	Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.	Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.	During the 7-day (Days 0-6) post vaccination period
Primary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.	Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (=) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.	During the 7-day (Days 0-6) post vaccination period
Primary	Number of Subjects With New Onset of Chronic Diseases (NOCDs).	NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.	From Day 0 to Day 180
Primary	Number of Subjects With Medically Significant Conditions (MSCs).	MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.	From Day 0 to Day 180
Primary	Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).	Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.	During the 30-day (Days 0-29) post-vaccination period
Primary	Number of Subjects With Any and Related Serious Adverse Events (SAEs).	SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.	During the entire study period (Days 0-180)

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