EUCTR2013-001231-51-IT
Active, not recruiting
Phase 1
Efficacy and Immunogenicity Study of Quadrivalent Influenza Vaccine Administered via the Intramuscular Route in Healthy Children Aged 6 to 35 Months
ConditionsPrevention of influenza infection in children aged 6 to 35 monthsMedDRA version: 16.1Level: LLTClassification code 10022001Term: Influenza (epidemic)System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsVaxigrip
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of influenza infection in children aged 6 to 35 months
- Sponsor
- Sanofi Pasteur
- Enrollment
- 9000
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy children aged 6 to less than 36 months not previously vaccinated against influenza.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9000
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •At risk” children according to the definition from the Advisory Committee on Immunization Practices (ACIP).
Outcomes
Primary Outcomes
Not specified
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