EUCTR2009-016877-14-DK
Active, not recruiting
Phase 1
H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A-H1N1v Vaccination in Pregnant Women
COPSAC0 sites500 target enrollmentOctober 30, 2009
DrugsFocetria
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- COPSAC
- Enrollment
- 500
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria
- •Healthy pregnant and non\-pregnant women living in Eastern Denmark
- •Fluent in Danish
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •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
- •Heart disease, endocrine disease, tuberculosis and sarcoidosis.
- •History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to influenza viral proteins, to any excipients, and to eggs (including ovalbumin), and chicken proteins
Outcomes
Primary Outcomes
Not specified
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