Recent Updates
Recently added Catalysts

Influenza vaccine GSK1562902A

Phase 3

Influenza | Vaccine | Infectious Disease |GSK plc|Trials Updated: Sep 7, 2018

Influenza vaccine GSK1562902A target and mechanism

ModalityVaccine

Also known as Influenza vaccine GSK1562902A Formulation 1, Influenza vaccine GSK1562902A Formulation 2

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment520

FDA Designations

No designations recorded

Influenza vaccine GSK1562902A clinical trials

Influenza vaccine GSK1562902A · 1 trial · 1 indication

Phase 3 1
NCT01379937A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in ChildrenInfluenza
COMPLETED520 Analytics
PHASE3COMPLETED
A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Haemagglutination Inhibition (HI) Antibody Titers for the A/Turkey/Turkey/01/2005 (H5N1) Vaccine Strain.
At Day 192.

Antibody titers were expressed as Geometric mean titers (GMTs). The H5N1 vaccine strain included A/Turkey/Turkey/01/2005 antigen. The A/Turkey/Turkey/01/2005 (A/TURK) vaccine strain was administered to groups receiving the adjuvanted Influenza vaccine GSK1562902A. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Number of Subjects With Any Medically Attended Adverse Events (MAEs)
From Day 0 to Day 182

Any = occurrence of the symptom regardless of intensity grade. This outcome concerns solely subjects in the GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group as required by the protocol.

Secondary Endpoints

H5N1 HI Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
At Days 0, 42, 182, 192, 364
H5N1 HI Neutralizing Antibody Titres Against the A/Indonesia/5/2005 and A/Turkey/Turkey/01/2005 (H5N1 Virus) Strains
At Days 0, 42, 182, 192, 364
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
During a 7-day (Day 0-6) follow-up period after each vaccination
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr GroupEXPERIMENTALSubjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
GSK1562902A Formulation 1 - Havrix / Havrix Jr GroupEXPERIMENTALSubjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
GSK1562902A Formulation 2 - Havrix / Havrix Jr GroupACTIVE_COMPARATORSubjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
Havrix / Havrix Jr GroupACTIVE_COMPARATORSubjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.

Interventions

NameTypeDescription
Influenza vaccine GSK1562902A Formulation 1BIOLOGICALIntramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
Influenza vaccine GSK1562902A Formulation 2BIOLOGICALIntramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
Havrix™BIOLOGICALIntramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Havrix™ JuniorBIOLOGICALIntramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
Unlock Study Design Details

Eligibility Criteria

Age Range3 Years to 17 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol . * A male or female child 3 to 17 yea...

Countries:Philippines
Unlock Eligibility Criteria

Frequently asked questions about Influenza vaccine GSK1562902A

What is Influenza vaccine GSK1562902A?

Influenza vaccine GSK1562902A is an investigational vaccine developed by GSK plc for the prevention of influenza. It is a vaccine candidate that has been studied in a Phase 3 clinical trial in children. The vaccine is also referred to as Influenza vaccine GSK1562902A Formulation 1 and Formulation 2.

What is Influenza vaccine GSK1562902A used for?

Influenza vaccine GSK1562902A is being developed for the prevention of influenza, a contagious respiratory illness. Its clinical evaluation has focused on use in children, specifically those aged 3 years and older. The vaccine is intended to protect against influenza infection.

Who makes Influenza vaccine GSK1562902A?

Influenza vaccine GSK1562902A is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK is the sponsor of the clinical program evaluating this influenza vaccine candidate.

What phase is Influenza vaccine GSK1562902A in?

Influenza vaccine GSK1562902A is in Phase 3 clinical development. The Phase 3 trial evaluating the vaccine has been completed. The vaccine is investigational and is not described as approved by the FDA.

What clinical trials is Influenza vaccine GSK1562902A in?

Influenza vaccine GSK1562902A has been evaluated in one Phase 3 clinical trial, NCT01379937, titled A Study to Evaluate the Safety and Immunogenicity of a Prime-boost Schedule of GSK Biologicals' Influenza Vaccine in Children. The trial enrolled 520 participants in the Philippines and has been completed.

Is Influenza vaccine GSK1562902A the same as Formulation 1 or Formulation 2?

Yes. Influenza vaccine GSK1562902A is also known as Influenza vaccine GSK1562902A Formulation 1 and Influenza vaccine GSK1562902A Formulation 2. These names refer to the same GSK influenza vaccine candidate studied in the Phase 3 trial NCT01379937.