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Inactivated influenza vaccine NH 2007-2008 formulation

Phase 2

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Jan 17, 2014

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment130

FDA Designations

No designations recorded

Clinical trial landscape

Inactivated influenza vaccine NH 2007-2008 formulation · 1 trial · 2 indications

Phase 2 1
NCT00491257A Study of the Immunogenicity and Safety of the 2007-2008 Influenza VaccineInfluenza
COMPLETED130 Analytics
PHASE2COMPLETED
A Study of the Immunogenicity and Safety of the 2007-2008 Influenza Vaccine
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

To provide information concerning the immunogenicity of 2007-2008 Influenza vaccine (split virion, inactivated).
21 Days post-vaccination
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Study Group 1EXPERIMENTALParticipants aged 18 to 60 years at enrollment
Study Group 2EXPERIMENTALParticipants aged 61 years or older at enrollment.

Interventions

NameTypeDescription
Inactivated influenza vaccine (split virion) NH 2007-2008 formulationBIOLOGICAL0.5 mL, Intramuscular
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria : * Aged 18 to 60 years (i.e. to the day before the 61st birthday) or 61 years or above (from the day of the 61st birthday) on the day of inclusion * Provision of a signed informed consent * Able to attend all scheduled visits and comply with all trial procedures * For a woman of...

Countries:United Kingdom
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