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Clinical Trials/EUCTR2013-001231-51-GR
EUCTR2013-001231-51-GR
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

Sanofi Pasteur0 sites9,000 target enrollmentJune 2, 2014
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ConditionsPrevention of influenza infection in children aged 6 to 35 monthsMedDRA version: 17.0Level: 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
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2014
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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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