Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

Influenza Clinical Trial

Official title:

Observer-blind Superior Efficacy Trial With GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753272
• Other study ID #: 106372
• Status: Completed
• Phase: Phase 3
• Start date: September 15, 2008
• Est. completion date: January 5, 2011

Study information

• Verified date: August 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals' influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided in two surveillance phases: one passive phase along the study during the influenza season and one active surveillance phase during the influenza peak season.

Description:

This Protocol Posting has been updated according to Protocol Amendment 3, Sep 2009.

After the analyses for this study were completed, questions arose regarding the integrity of study data from a single study site in Romania, which enrolled 102 subjects in the trial. Because evaluation of data from this site did not reveal irregularities when compared with overall study data and because GSK has no current plans to use the data from the study in support of any regulatory filings, they were not excluded from the analyses reflected in this results summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43695
• Est. completion date: January 5, 2011
• Est. primary completion date: June 18, 2010
• 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.

• A man or woman aged 65 years or older at the time of the vaccination.

• Written informed consent obtained from the subject.

• Subjects with residence status allowing free mixing with general community.

Exclusion Criteria:

• Bedridden subjects

• Previous vaccination against influenza since February 2008.

• Previous vaccination in the last three years with an investigational adjuvanted candidate seasonal or pandemic influenza vaccine.

• 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.

• Any contra-indication to intramuscular administration of the influenza vaccines.

• 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 including egg and chicken protein.

• Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GSK Bio's influenza vaccine GSK2186877A
IM administration, two times one annual dose, 3 different lots will be tested
• Fluarix TM
IM administration, two times one annual dose

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Anthée
Belgium	GSK Investigational Site	Deinze
Belgium	GSK Investigational Site	Dour
Belgium	GSK Investigational Site	Drongen
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Gozée
Belgium	GSK Investigational Site	Hamois (Natoye)
Belgium	GSK Investigational Site	Kerksken
Belgium	GSK Investigational Site	Libramont
Belgium	GSK Investigational Site	Linkebeek
Belgium	GSK Investigational Site	Maldegem
Belgium	GSK Investigational Site	Melsbroek
Belgium	GSK Investigational Site	Merelbeke
Belgium	GSK Investigational Site	Mettet
Belgium	GSK Investigational Site	Oostakker
Belgium	GSK Investigational Site	Waarschoot
Canada	GSK Investigational Site	Bay Roberts	Newfoundland and Labrador
Canada	GSK Investigational Site	Brampton	Ontario
Canada	GSK Investigational Site	Coquitlam	British Columbia
Canada	GSK Investigational Site	Gatineau	Quebec
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St-Romulad	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
Canada	GSK Investigational Site	Vancouver	British Columbia
Czechia	GSK Investigational Site	Hradec Kralove
Czechia	GSK Investigational Site	Jaromer
Czechia	GSK Investigational Site	Jaromer
Czechia	GSK Investigational Site	Pardubice
Czechia	GSK Investigational Site	Pardubice
Czechia	GSK Investigational Site	Pardubice
Estonia	GSK Investigational Site	Saku
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Estonia	GSK Investigational Site	Tartu
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Angers
France	GSK Investigational Site	Anzin
France	GSK Investigational Site	Arras
France	GSK Investigational Site	Bécon les Granits
France	GSK Investigational Site	Bordeaux
France	GSK Investigational Site	Cannes
France	GSK Investigational Site	Chambery
France	GSK Investigational Site	Château Gontier
France	GSK Investigational Site	Clermont-Ferrand
France	GSK Investigational Site	Ecouflant
France	GSK Investigational Site	Gresy sur Aix
France	GSK Investigational Site	La Rochelle
France	GSK Investigational Site	Laval
France	GSK Investigational Site	Le Fousseret
France	GSK Investigational Site	Montpellier Cedex 5
France	GSK Investigational Site	Montreuil Juigne
France	GSK Investigational Site	Muret
France	GSK Investigational Site	Nieul sur Mer
France	GSK Investigational Site	Oignies
France	GSK Investigational Site	Orthez
France	GSK Investigational Site	Paris
France	GSK Investigational Site	Paris Cedex 18
France	GSK Investigational Site	Rosiers d'Egletons
France	GSK Investigational Site	Saint Etienne
France	GSK Investigational Site	Segré
France	GSK Investigational Site	Seysses
France	GSK Investigational Site	Tierce
France	GSK Investigational Site	Tours
France	GSK Investigational Site	Vourey
Germany	GSK Investigational Site	Augsburg	Bayern
Germany	GSK Investigational Site	Bad Bramstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Bad Kreuznach	Hessen
Germany	GSK Investigational Site	Bad Segeberg	Schleswig-Holstein
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bochum	Nordrhein-Westfalen
Germany	GSK Investigational Site	Borna	Sachsen
Germany	GSK Investigational Site	Brinkum/Stuhr	Niedersachsen
Germany	GSK Investigational Site	Cottbus	Brandenburg
Germany	GSK Investigational Site	Delitzsch	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Duelmen	Niedersachsen
Germany	GSK Investigational Site	Erfurt	Thueringen
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Floersheim	Hessen
Germany	GSK Investigational Site	Freiberg	Sachsen
Germany	GSK Investigational Site	Freital	Sachsen
Germany	GSK Investigational Site	Geringswalde	Sachsen
Germany	GSK Investigational Site	Goch	Nordrhein-Westfalen
Germany	GSK Investigational Site	Gueglingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Haag	Bayern
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hoehenkirchen-Siegertsbrunn	Bayern
Germany	GSK Investigational Site	Ingelheim	Rheinland-Pfalz
Germany	GSK Investigational Site	Kallstadt	Rheinland-Pfalz
Germany	GSK Investigational Site	Ketzin	Brandenburg
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Koenigslutter	Niedersachsen
Germany	GSK Investigational Site	Koethen	Sachsen-Anhalt
Germany	GSK Investigational Site	Kuenzing	Bayern
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Luebeck	Schleswig-Holstein
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mainz	Rheinland-Pfalz
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Messkirch	Baden-Wuerttemberg
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenster	Nordrhein-Westfalen
Germany	GSK Investigational Site	Rednitzhembach	Bayern
Germany	GSK Investigational Site	Rhaunen	Rheinland-Pfalz
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rotenburg (Wuemme)	Niedersachsen
Germany	GSK Investigational Site	Rudersberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ruedersdorf	Brandenburg
Germany	GSK Investigational Site	Schmiedeberg	Sachsen
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Schwetzingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Sinsheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Tuebingen	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weinheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Weissenberg	Sachsen
Germany	GSK Investigational Site	Witten	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wolmirstedt	Sachsen-Anhalt
Germany	GSK Investigational Site	Wuerzburg	Bayern
Mexico	GSK Investigational Site	Cuernavaca	Morelos
Mexico	GSK Investigational Site	Ecatepec de Morelos	Estado De México
Mexico	GSK Investigational Site	Mexico
Mexico	GSK Investigational Site	Monterrey	Nuevo León
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Soest
Netherlands	GSK Investigational Site	Utrecht
Norway	GSK Investigational Site	Alesund
Norway	GSK Investigational Site	Bekkestua
Norway	GSK Investigational Site	Bergen
Norway	GSK Investigational Site	Elverum
Norway	GSK Investigational Site	Hamar
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Oslo
Norway	GSK Investigational Site	Skien
Norway	GSK Investigational Site	Stavanger
Poland	GSK Investigational Site	Bydgoszcz
Poland	GSK Investigational Site	Debica
Poland	GSK Investigational Site	Grodzisk Mazowiecki
Poland	GSK Investigational Site	Ilawa
Poland	GSK Investigational Site	Inowroclaw
Poland	GSK Investigational Site	Katowice
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Krakow
Poland	GSK Investigational Site	Lubartow
Poland	GSK Investigational Site	Olesnica
Poland	GSK Investigational Site	Plock
Poland	GSK Investigational Site	Porabka
Poland	GSK Investigational Site	Siemianowice Slaskie
Poland	GSK Investigational Site	Sopot
Poland	GSK Investigational Site	Torun
Poland	GSK Investigational Site	Trzebnica
Poland	GSK Investigational Site	Tychy
Poland	GSK Investigational Site	Wroclaw
Romania	GSK Investigational Site	Braila
Romania	GSK Investigational Site	Braila
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Brasov
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Bucharest
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Galati
Romania	GSK Investigational Site	Galati
Romania	GSK Investigational Site	Pantelimon
Romania	GSK Investigational Site	Ploiesti
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Ekaterinburg
Russian Federation	GSK Investigational Site	Perm
Russian Federation	GSK Investigational Site	Perm
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
United Kingdom	GSK Investigational Site	Buckshaw Village, Chorley	Lancashire
United Kingdom	GSK Investigational Site	Liverpool	Merseyside
United Kingdom	GSK Investigational Site	Reading	Berkshire
United Kingdom	GSK Investigational Site	Waterloo, Liverpool
United States	GSK Investigational Site	Alabaster	Alabama
United States	GSK Investigational Site	Anaheim	California
United States	GSK Investigational Site	Boise	Idaho
United States	GSK Investigational Site	Camillus	New York
United States	GSK Investigational Site	Carnegie	Pennsylvania
United States	GSK Investigational Site	Cary	North Carolina
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clearwater	Florida
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Crystal River	Florida
United States	GSK Investigational Site	Delray Beach	Florida
United States	GSK Investigational Site	Endwell	New York
United States	GSK Investigational Site	Erie	Pennsylvania
United States	GSK Investigational Site	Grove City	Pennsylvania
United States	GSK Investigational Site	Hackensack	New Jersey
United States	GSK Investigational Site	Hickory	North Carolina
United States	GSK Investigational Site	Hot Springs	Arkansas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Inverness	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Jefferson Hills	Pennsylvania
United States	GSK Investigational Site	Johnson City	New York
United States	GSK Investigational Site	Kansas City	Missouri
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Marshfield	Wisconsin
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mesa	Arizona
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	North Myrtle Beach	South Carolina
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Pembroke Pines	Florida
United States	GSK Investigational Site	Peoria	Illinois
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Saint Louis	Missouri
United States	GSK Investigational Site	Salisbury	North Carolina
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Salt Lake City	Utah
United States	GSK Investigational Site	Santa Ana	California
United States	GSK Investigational Site	Somers Point	New Jersey
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Tabor City	North Carolina
United States	GSK Investigational Site	Tempe	Arizona
United States	GSK Investigational Site	Uniontown	Pennsylvania
United States	GSK Investigational Site	Upper Saint Clair	Pennsylvania
United States	GSK Investigational Site	Warwick	Rhode Island
United States	GSK Investigational Site	West Jordan	Utah
United States	GSK Investigational Site	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Czechia,  Estonia,  France,  Germany,  Mexico,  Netherlands,  Norway,  Poland,  Romania,  Russian Federation,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.	Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.	After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season))
Primary	Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.	Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the lot-to-lot subset of subjects.	At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Secondary	Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.	Occurrence of PCR-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). PCR-confirmed influenza (PCI) was defined as an episode of influenza-like illness (ILI) occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by reverse transcription polymerase chain reaction (RT-PCR) analysis.	During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Secondary	Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.	Occurrence of culture-confirmed influenza A and/or B infection, due to any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v). Culture-confirmed influenza (CCI) was defined as an episode of ILI occurring after the administration of the study vaccine for which a nasal and throat swab specimen yields influenza virus A and/or B by viral culture analysis.	During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010)
Secondary	Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.	Clinical influenza= An ILI episode (with an ILI onset from the 15th of November until the end of the surveillance period) with at least simultaneously fever (oral temperature of =37.8 degrees Celsius) and cough.; The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).	During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Secondary	Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.	The influenza peak season = period during the study with the highest incidence of any matching or drift influenza strain relative to the vaccine strains (i.e. not emerging novel human influenza strain like H1N1v).	During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Secondary	Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine	Respiratory disease: A diagnosis of respiratory disease included: acute respiratory infections, other diseases of upper respiratory tract, pneumonia and influenza, chronic obstructive pulmonary disease and allied conditions, pneumoconioses and other lung diseases due to external agents, other diseases of respiratory system. In case the event has a fatal outcome, the diagnosis can also be confirmed by autopsy.	During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).	Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.; Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination	Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).	Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.; Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination	Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).	Adverse events of specific interest for safety monitoring are a subset of AEs that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.; Grade 3 = event that prevented normal everyday activities Related = event assessed by the investigator as causally related to the study vaccination	During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Secondary	Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.; Related = event assessed by the investigator as causally related to the study vaccination	During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010)
Secondary	Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.	Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter	During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Secondary	Number of Days With Any Grade of Solicited Local Symptoms	Solicited local symptoms assessed were ecchymosis, pain, redness and swelling	During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Secondary	Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms	Solicited local symptoms assessed were ecchymosis, pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = considerable pain at rest that prevented normal everyday activities. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling above 100 millimeter	During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Secondary	Number of Days With Any Grade of Solicited Local Symptoms.	Solicited local symptoms assessed were ecchymosis, pain, redness and swelling.	During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms	Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (=) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature =39.0°C - = 40.0°C.	During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Secondary	Number of Days With Any Grade of Solicited General Symptoms	Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.	During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.	Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (=) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature =39.0°C - = 40.0°C.	During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Secondary	Number of Days With Any Grade of Solicited General Symptoms.	Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature.	During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.	Within 21 days (Days 0-20) after the first dose (Year 2008/2009)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.	Within 21 days (Days 0-20) after the second dose (Year 2009/2010)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit	For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.	Within 180 days (Days 0-179) after the first dose (Year 2008/2009)
Secondary	Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.	For each solicited and unsolicited symptom the subject experienced, the subjects were asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Grade 3 = event that prevented normal everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.	Within 180 days (Days 0-179) after the second dose (Year 2009/2010)
Secondary	Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.	Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.	At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Secondary	Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains	Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects in the immunogenicity subset of subjects.	At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Secondary	Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.	Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.	At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study
Secondary	Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.	Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.	At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study
Secondary	Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains	In the lot-to-lot subset of subject in the FluGN Group. Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Seroconversion is defined as the number of subjects with pre-vaccination HI titer (Day 0) < 1:10 and post-vaccination titer (Day 21) = 1:40 or a pre-vaccination HI titer (Day 0) = 1:10 and fold-increase (post/pre) = 4.	At Day 21 of the first year (2008/2009) of the study.

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