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Influenza vaccine GSK2186877A formulation 1

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Sep 24, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Influenza vaccine GSK2186877A formulation 1 · 1 trial · 1 indication

Phase 1 1
NCT01096056Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy ChildrenInfluenza
COMPLETED40 Analytics
PHASE1COMPLETED
Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Subjects Reporting Fever Grade 2 or Higher
Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A

Fever grade greater than or equal to 2 i.e. ≥ 2 was defined as axillary temperature \>38 degree centigrade (°C).

Secondary Endpoints

Haemagglutination Inhibition (HI) Antibody Titers
At Day 0 and Day 42
The Number of Subjects Seropositive to HI Antibodies
At Day 0 and Day 42
The Number of Subjects Seroprotected to HI Antibodies
At Day 0 and Day 42
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Influenza vaccine GSK2186877A formulation 1 GroupEXPERIMENTALSubjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
Influenza vaccine GSK2186877A formulation 2 GroupEXPERIMENTALSubjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.

Interventions

NameTypeDescription
Influenza vaccine GSK2186877A formulation 1BIOLOGICALIntramuscular administration, 2 doses
Influenza vaccine GSK2186877A formulation 2BIOLOGICALIntramuscular administration, 1 dose
FluarixBIOLOGICALIntramuscular administration, 1 dose
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Eligibility Criteria

Age Range6 Months to 35 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All subjects must satisfy ALL the following criteria at study entry: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * Children, male or female between, and includ...

Countries:Spain
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Frequently asked questions about Influenza vaccine GSK2186877A formulation 1

What is Influenza vaccine GSK2186877A formulation 1 used for?

Influenza vaccine GSK2186877A formulation 1 is an investigational vaccine being developed for the prevention of influenza. It is currently in Phase 1 clinical development and has been studied in healthy children aged 6 months and older. The vaccine is designed to elicit an immune response against influenza viruses.

Who makes Influenza vaccine GSK2186877A formulation 1?

Influenza vaccine GSK2186877A formulation 1 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety and immunogenicity of this vaccine candidate in pediatric populations.

What phase is Influenza vaccine GSK2186877A formulation 1 in?

Influenza vaccine GSK2186877A formulation 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and immunogenicity in healthy children.

What clinical trials is Influenza vaccine GSK2186877A formulation 1 in?

Influenza vaccine GSK2186877A formulation 1 has been evaluated in one completed Phase 1 clinical trial, identified as NCT01096056. This trial, titled 'Trial to Evaluate the Safety and the Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Healthy Children,' enrolled 40 participants in Spain and was a controlled, randomized study.

Is Influenza vaccine GSK2186877A formulation 1 the same as GSK2186877A?

Yes, Influenza vaccine GSK2186877A formulation 1 is also known as GSK2186877A. The clinical trial NCT01096056 refers to the vaccine as GSK2186877A, and the formulation 1 designation specifies the particular version being tested. Both names refer to the same investigational influenza vaccine candidate.