Revaccination With Influenza Vaccine GSK1247446A

Influenza Clinical Trial

Official title:

Safety and Immunogenicity of a Second Vaccination With GSK Biologicals' Influenza Vaccine GSK1247446A in Subjects 18-60 Years Previously Vaccinated in Study 108656

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545025
• Other study ID #: 110674
• Secondary ID: 2007-002783-10
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2007
• Est. completion date: December 12, 2007

Study information

• Verified date: June 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: December 12, 2007
• Est. primary completion date: December 12, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial.

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

• Written informed consent obtained from the subject.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.

Exclusion Criteria:

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

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

• Previous vaccination against influenza since January 2007.

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

• Chronic administration 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 three months preceding the dose of study vaccine or planned administration during the study period.

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

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

• Pregnancy.

• 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:
• Influenza Vaccine GSK1247446A
Single dose, Intramuscular injection
• Fluarix™
Single dose, Intramuscular injection

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.	During a 7-day (Days 0-6) follow-up period after re-vaccination
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, myalgia, nausea 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 a 7-day (Days 0-6) follow-up after re-vaccination
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 causally related to the study vaccination.	During a 30-day (Days 0-29) follow-up period after re-vaccination
Primary	Number of Subjects With Any and Related Serious Adverse Events (SAEs)	Serious adverse events (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. Related = SAE assessed by the investigator as causally related to the study vaccination.	During the entire study period (Days 0-30)
Secondary	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/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.	At Days 0 and 21
Secondary	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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).	At Day 21
Secondary	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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).	At Day 0 and 21
Secondary	Seroconversion Factor for 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 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).	At Day 21

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.