Safety and immunogenicity of repeated annual exposure to the aQIV vaccine in children following vaccination in trials V118_05 and V118_05E1

Phase 1

• Conditions: Prophylaxis for influenza virus; MedDRA version: 18.0Level: PTClassification code 10022000Term: InfluenzaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-003008-22-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 486

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 subjects from Season 1 of V118_05E1 who have completed their clinic Visit 13 (Day 366).
3. Subject whose treatment assignment in study V118_05E1 has remained blinded to the child and the child’s parent(s)/legal guardian(s).
Are the trial subjects under 18? yes
Number of subjects for this age range: 486
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 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.

Study & Design

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