Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenze Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Vaccinated in Trial V118_05

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: EUCTR2014-002599-95-FI
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-23
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
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 Day 181 clinic visit for non-naïve
subjects or their Day 209 clinic visit for naïve subjects in parent study V118_05.
3. Subject whose treatment assignment in study V118_05 has remained blinded.
4. 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 the non-adjuvanted comparator).
Are the trial subjects under 18? yes
Number of subjects for this age range: 1400
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

In order to participate in this study, all subjects must meet NONE of the exclusion criteria
described:
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 Folder).
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 are 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 study through the duration of this trial.

Study & Design

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