Immunogenicity and Safety of Quadrivalent Influenza Vaccine (VaxigripTetra™) inPregnant Wome

Phase 1

• Conditions: Prophylaxix of influenza in Pregnant Women; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004763-40-FI
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Last Update Posted: 23 July 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 729

Inclusion Criteria

- Aged at least 18 years on the day of inclusion
- Pregnant women with estimated gestational age of 20 to 32 weeks
Are the trial subjects under 18? no
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 729
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Previous vaccination against influenza with the 2017-2018 Northern hemisphere formulation with either the trial vaccines or another vaccine
- Pregnancy complications (in the current pregnancy)
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified