Revaccination With Influenza Vaccine GSK1247446A

• ClinicalTrials.gov Identifier: NCT00545025
• Recruitment Status: Completed
• First Posted: October 16, 2007
• Results First Posted: May 7, 2013
• Last Update Posted: June 26, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Influenza; Influenza, Human	Biological: Influenza Vaccine GSK1247446A; Biological: Fluarix™	Phase 2

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 243 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: October 15, 2007
• Actual Primary Completion Date: December 12, 2007
• Actual Study Completion Date: December 12, 2007

Arms and Interventions

Arm	Intervention/treatment
Experimental: GSK1247446A Group; 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; Single dose, Intramuscular injection
Active Comparator: Fluarix Group; 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™; Single dose, Intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms [ Time Frame: During a 7-day (Days 0-6) follow-up period after re-vaccination ]
   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.
2. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During a 7-day (Days 0-6) follow-up after re-vaccination ]
   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.
3. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During a 30-day (Days 0-29) follow-up period after re-vaccination ]
   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.
4. Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Days 0-30) ]
   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.

Secondary Outcome Measures :

1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. [ Time Frame: At Days 0 and 21 ]
   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.
2. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ]
   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).
3. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. [ Time Frame: At Day 0 and 21 ]
   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).
4. Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. [ Time Frame: At Day 21 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Belgium

GSK Investigational Site

Wilrijk, Belgium, 2610

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

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

Study Data/Documents: Individual Participant Data Set 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

Study Protocol 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

Dataset Specification 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

Annotated Case Report Form 

Identifier: 110674
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00545025
• Other Study ID Numbers: 110674; 2007-002783-10 ( EudraCT Number )
• First Posted: October 16, 2007
• Results First Posted: May 7, 2013
• Last Update Posted: June 26, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Influenza; Influenza vaccine

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases