Revaccination With Influenza Vaccine GSK1247446A

NCT00545025 | Completed Phase 2 Results

• 2 other identifiers: 1106742007-002783-10
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza; Influenza, Human

Keywords

Influenza; Influenza vaccine

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (4)

• Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  At Days 0 and 21

• Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.

  At Day 21

• Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.

  At Day 0 and 21

• Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease.

  At Day 21

Study Arms (2)

GSK1247446A Group

EXPERIMENTAL

Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.

Biological: Influenza Vaccine GSK1247446A

Fluarix Group

ACTIVE COMPARATOR

Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltiod region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.

Biological: Fluarix™

Interventions

Influenza Vaccine GSK1247446A BIOLOGICAL

Single dose, Intramuscular injection

GSK1247446A Group

Fluarix™ BIOLOGICAL

Single dose, Intramuscular injection

Fluarix Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wilrijk, 2610, Belgium

Location

Related 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.

MeSH Terms

Conditions

Influenza, Human

Interventions

fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2007
• First Posted: October 16, 2007
• Study Start: October 15, 2007
• Primary Completion: December 12, 2007
• Study Completion: December 12, 2007
• Last Updated: June 26, 2019
• Results First Posted: May 7, 2013

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)