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Vaxigrip trivalent inactivated influenza vaccine

Phase 1

Influenza | Vaccine | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Aug 5, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment450

FDA Designations

No designations recorded

Clinical trial landscape

Vaxigrip trivalent inactivated influenza vaccine · 1 trial · 1 indication

Phase 1 1
NCT00386542Needle-free Jet Injection of Reduced-dose, Intradermal, Influenza Vaccine in >= 6 to < 24-month-old ChildrenInfluenza
COMPLETED450 Analytics
PHASE1COMPLETED
Needle-free Jet Injection of Reduced-dose, Intradermal, Influenza Vaccine in >= 6 to < 24-month-old Children
Influenza
NCT00386542450
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Study Endpoints

Primary Endpoints

Rates of seroconversion (SC) on HI assay 1 month after dose 2. SC defined as titer >= 40 among initial-seronegatives (titer < 8 on day 0); OR, a followup titer which rises >= 4-fold.
One month after each of doses 1 and 2.

seroconversion and safety assessed through occurrence of local and systemic reactions

Secondary Endpoints

Rates of local and systemic reactions
Up to 42 days for prompted symptoms after investigational doses 1 and 2. Up to 6 months for unsolicited ones.
Seroprotection (SP) on HI assay, defined as >= 40 regardless of baseline
One month after each of doses 1 and 2.
Geometric mean titers (GMT) on HI
One month after each of doses 1 and 2.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
ID-JI-0.1EXPERIMENTALGroup "ID-JI-0.1" (n = 16) - reduced 0.1 mL INF doses administered intradermally (ID) by needle-free jet injector (JI) (Biojector® 2000 subcutaneous syringe no. 2 \[green color code\], with 2 cm investigational spacer, Bioject Medical Technologies, Inc., Portland, OR, USA)
IM-NS-0.1ACTIVE_COMPARATORGroup "IM-NS-0.1" (n = 16) - reduced 0.1 mL INF doses administered intramuscularly (IM) needle-syringe (NS) (via 22-25 gauge needle, minimum 25 mm/1-inch length)
IM-NS-0.25 controlACTIVE_COMPARATORGroup "IM-NS-0.25" (controls) (n = 16) - full 0.25 mL INF doses administered intramuscularly (IM) by needle-syringe (NS) (22-25 gauge needle, minimum 25 mm/1-inch length)

Interventions

NameTypeDescription
Vaxigrip® trivalent inactivated influenza vaccineBIOLOGICALSee full description elsewhere in this record.
Intradermal spacer on Biojector® 2000 jet injectorDEVICESee elsewhere in this record for full description.
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Eligibility Criteria

Age Range6 Months to 24 Months
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age from \> = 6 to \< 24 months (not having reached 2nd birthday). * Born after a full-term (≥ 37 weeks), and birth weight of \>= 2.5 kg (\>= 5 pounds, 8 ounces) * History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunization or ...

Countries:Dominican Republic
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Competitive Landscape -Influenza 13 trials

Top 6 of 9 competitors

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Quadrivalent influenza vaccine (split virion), inactivated
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
GSK plc Sponsored ADRGSK1PHASE1Flu/COVID-19 mRNA combination vaccine
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