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Safety, Tolerability, Immunogenicity And CPG Dosage Finding Study of Novartis CpG Adjuvanted Flu Vaccine

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Novartis

Status and phase

Completed
Phase 1

Conditions

Influenza Infection

Treatments

Biological: Adjuvanted influenza vaccine combine with CpG7909
Biological: Adjuvanted influenza vaccine
Biological: Subunit influenza vaccine
Biological: Adjuvanted influenza vaccine combined with CpG7909

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

To evaluate the safety and tolerability of the an adjuvanted influenza vaccine combined with CpG7909 at three different doses of CpG 7909 as a single intramuscular (IM) administration in healthy adults. Safety will be assessed by observation of symptoms, physical examination findings and laboratory safety testing.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy subjects aged 18 to ≤40 years

Exclusion criteria

  • Any serious disease, hypersensitivity to egg or vaccine components, neurological symptoms or positive antibody test against dsDNA, RF, ANA or thyroid.
  • Abnormal TSH from blood samples collected during the screening visit;

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 5 patient groups

1
Active Comparator group
Treatment:
Biological: Subunit influenza vaccine
2
Active Comparator group
Treatment:
Biological: Adjuvanted influenza vaccine
3
Experimental group
Treatment:
Biological: Adjuvanted influenza vaccine combined with CpG7909
4
Experimental group
Treatment:
Biological: Adjuvanted influenza vaccine combine with CpG7909
5
Experimental group
Treatment:
Biological: Adjuvanted influenza vaccine combine with CpG7909

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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