Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate

NCT00385840 | Completed Phase 2 Results

• 1 other identifier: 108708
• Study Type: interventional
• Target: 678
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above

Conditions

Influenza

Keywords

Influenza vaccine; Influenza

Outcome Measures

Primary Outcomes (4)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

  Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = Incidence of a particular solicited local symptom regardless of intensity grade. Grade 3 pain = Pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).

  During the 7-day (Days 0-6) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

  Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering. Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination. Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C). Grade 3 symptom = Symptom that prevented normal activity. Grade 3 fever = Axillary temperature \> 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

• 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 vaccination.

  During the 30-day (Days 0-29) post vaccination period

• 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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.

  During the entire study period (from Day 0 to Day 29)

Secondary Outcomes (4)

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

  At Day 0 and Day 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 Day 21

• Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.

  At Day 21

Study Arms (2)

Fluarix Group

ACTIVE COMPARATOR

Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: FluarixTM

GSK1247446A Group

EXPERIMENTAL

Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Influenza Vaccine GSK1247446A

Interventions

Influenza Vaccine GSK1247446A BIOLOGICAL

Single dose, intramuscular injection

GSK1247446A Group

FluarixTM BIOLOGICAL

Single dose, intramuscular injection

Fluarix Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 \& 107214 clinical trials.
• 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.

You may not qualify if:

• 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 3 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (4)

GSK Investigational Site

Elverum, 2408, Norway

Location

GSK Investigational Site

Hamar, 2301, Norway

Location

GSK Investigational Site

Paradis, 5231, Norway

Location

GSK Investigational Site

Stavanger, 4010, Norway

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

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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: October 20, 2006
• Primary Completion: February 1, 2007
• Study Completion: February 5, 2007
• Last Updated: June 8, 2018
• Results First Posted: April 29, 2013

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

NO (4)