Clinical Study to Evaluate Safety and Immunogenicity of Investigational Flu Vaccine Compared to Approved Flu Vaccine (Fluzone) in Childre

Phase 1

• Conditions: Prophylaxis for influenza virus; MedDRA version: 19.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-002973-39-FI
• Lead Sponsor: Seqirus UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-14
• Last Update Posted: 17 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

1. Subject’s parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
2. Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
3. For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Are the trial subjects under 18? yes
Number of subjects for this age range: 1600
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

1. Progressive, unstable or uncontrolled clinical conditions or any fatal condition (<12 month life expectancy).
2. History of epilepsy or convulsions (excluding febrile convulsions).
3. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see Investigator Study File).
4. Individuals who have been diagnosed with any disorders in growth such as failure to thrive or short stature.
5. Subjects hospitalized at the time of enrollment.
6. Subjects with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component, to eggs (including ovalbumin), and
chicken protein, latex.
7. Subjects who have received antipyretic medication within the past 24 hours prior to vaccination. The subject may return for vaccination after a period of 24 hours has passed since the administration of an antipyretic.
8. Subjects who have had a fever [body temperature measurement = 38°C (= 100.4°F)] within three consecutive days prior to vaccination. The subject may return for vaccination after they have been free of fever for three days.
9. Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
10. Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
11. Subjects who are children of research staff directly involved with the clinical study or who are otherwise related to research staff or have household members who are research staff. Research staff is individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.
12. Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.

Study & Design

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