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Adjuvanted and un-adjuvanted influenza vaccines

Phase 1

Influenza | Vaccine | Infectious Disease |Novartis AG|Trials Updated: Jan 24, 2014

Adjuvanted and un-adjuvanted influenza vaccines development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment410

FDA Designations

No designations recorded

Adjuvanted and un-adjuvanted influenza vaccines clinical trials

Adjuvanted and un-adjuvanted influenza vaccines · 1 trial · 1 indication

Phase 1 1
NCT00848887A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of AgeInfluenza
COMPLETED410 Analytics
PHASE1COMPLETED
A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.
50 days

Secondary Endpoints

Strain-specific influenza antibody titers will be used to assess Immunogenicity
50 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -

Interventions

NameTypeDescription
Adjuvanted and un-adjuvanted influenza vaccinesBIOLOGICAL16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.
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Eligibility Criteria

Age Range6 Months to 35 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator. Exclusion Criteria: * History of serious disease. History of serious reaction following administration of vaccine or hype...

Countries:Belgium
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Frequently asked questions about Adjuvanted and un-adjuvanted influenza vaccines

What is the adjuvanted and un-adjuvanted influenza vaccine developed by Novartis?

It is an investigational influenza vaccine developed by Novartis AG (ticker NVS) that combines adjuvanted and non-adjuvanted formulations. It was studied in healthy children aged 6 to under 36 months for the prevention of influenza. The program reached Phase 1 clinical development.

What is the adjuvanted and un-adjuvanted influenza vaccine used for?

It is being studied for the prevention of influenza in young children. The single Phase 1 trial enrolled healthy children 6 to under 36 months of age. The vaccine combines adjuvanted and non-adjuvanted formulations to evaluate different dose combinations for influenza protection.

Who makes the adjuvanted and un-adjuvanted influenza vaccine?

Novartis AG, which trades under the ticker NVS, is the developer of the adjuvanted and un-adjuvanted influenza vaccine. The company sponsored the Phase 1 dose-ranging study conducted in Belgium. Novartis is the sole developer named for this influenza vaccine candidate.

What phase is the adjuvanted and un-adjuvanted influenza vaccine in?

The adjuvanted and un-adjuvanted influenza vaccine is in Phase 1 development. It is investigational and has not been approved. The only trial, NCT00848887, is a completed Phase 1 dose-ranging study. No active trials are currently listed for this candidate.

What clinical trials is the adjuvanted and un-adjuvanted influenza vaccine in?

One clinical trial has evaluated the adjuvanted and un-adjuvanted influenza vaccine: NCT00848887, a Phase 1 dose-ranging study comparing different combinations of adjuvanted and non-adjuvanted influenza vaccines in healthy children 6 to under 36 months of age. The trial enrolled 410 participants in Belgium and is completed.

How was the Phase 1 trial of the adjuvanted and un-adjuvanted influenza vaccine designed?

NCT00848887 was a Phase 1 dose-ranging study comparing different combinations of adjuvanted and non-adjuvanted influenza vaccines. It enrolled 410 healthy children aged 6 to under 36 months in Belgium. The study was randomized and uncontrolled, and it has been completed.