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Influenza vaccine GSK1562902A Formulation 1

Phase 3

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 7, 2018

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment520

FDA Designations

No designations recorded

Clinical trial landscape

Influenza vaccine GSK1562902A Formulation 1 · 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
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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
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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
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Frequently asked questions about Influenza vaccine GSK1562902A Formulation 1

What is Influenza vaccine GSK1562902A Formulation 1 used for?

Influenza vaccine GSK1562902A Formulation 1 is an investigational vaccine being developed for the prevention of influenza. It is currently in Phase 3 clinical development and is intended for use in children, as the completed trial evaluated a prime-boost schedule in pediatric participants.

Who makes Influenza vaccine GSK1562902A Formulation 1?

Influenza vaccine GSK1562902A Formulation 1 is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.

What phase is Influenza vaccine GSK1562902A Formulation 1 in?

Influenza vaccine GSK1562902A Formulation 1 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 3 trial has been completed, and the vaccine remains under clinical investigation.

What clinical trials is Influenza vaccine GSK1562902A Formulation 1 in?

Influenza vaccine GSK1562902A Formulation 1 has been studied in one completed Phase 3 clinical trial, NCT01379937. This trial evaluated the safety and immunogenicity of a prime-boost schedule of the vaccine in children aged 3 years and older in the Philippines, enrolling 520 participants.

Is Influenza vaccine GSK1562902A Formulation 1 the same as other influenza vaccines?

Influenza vaccine GSK1562902A Formulation 1 is a specific investigational vaccine formulation developed by GSK. It is not known to be the same as other marketed influenza vaccines, as it is still in clinical development and has not been approved for use.