Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

Influenza Clinical Trial

Official title:

Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633074
• Other study ID #: 111454
• Status: Completed
• Phase: Phase 2
• Start date: March 3, 2008
• Est. completion date: April 11, 2008

Study information

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

Clinical Trial Summary

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 720
• Est. completion date: April 11, 2008
• Est. primary completion date: April 11, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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 65 years of age or older at the time of 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.

Exclusion Criteria:

• Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 up to 21 days after vaccination.

• Planned administration of an influenza vaccine other than the study vaccines during the entire study period.

• Previous vaccination against influenza with any seasonal vaccine since July 2007.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

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

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

• History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.

• Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

• Any medical conditions in which IM injections are contraindicated

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
• Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose

Locations

Country	Name	City	State
Estonia	GSK Investigational Site	Saku
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains	Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.	Days 0 and 21
Secondary	Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains	A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.	Days 0 and 21
Secondary	Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains	A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.	Day 21
Secondary	HI Antibody Seroconversion Factors	Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.	Day 21
Secondary	Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains	A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.	Days 0 and 21
Secondary	Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms	Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.	During a 7-day period after vaccination
Secondary	Duration of Solicited Local Symptoms	Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.	During a 7-day period after vaccination
Secondary	Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms	Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.	During a 7-day period after vaccination
Secondary	Duration of Solicited General Symptoms	Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.	During a 7-day period after vaccination
Secondary	Number of Subjects Reporting 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.	During a 21-day period after vaccination
Secondary	Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)	Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.	During a 21-day period after vaccination
Secondary	Number of Subjects Reporting 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.	During the entire study period (up to Day 21)

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