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

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2014-002599-95-FI
• Date of registration: 23/07/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: 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
• Scientific title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05 - aQIV re-vaccination study to evaluate safety and immunogenicity in children vaccinated in V118_05
• Date of first enrolment: 19/09/2014
• Target sample size: 1400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002599-95
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: Observer blind If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Finland, United States

Contacts

• Name: Filippo Pacciarini
• Affiliation: Novartis Vaccines Influenza S.r.l.

• Name: Filippo Pacciarini
• Affiliation: Novartis Vaccines Influenza S.r.l.

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Prophylaxis for influenza virus
MedDRA version: 18.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: Adjuvanted Quadrivalent Influenza Vaccine (aQIV) -surface antigen ,inactivated,adjuvanted with MF59
Product Code: aQIV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/ (H1N1) - like virus antigen
Other descriptive name: A/ (H1N1)-LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: B/ (Yamagata) - like virus antigen
Other descriptive name: B/ -LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: B/ (Victoria) - like virus antigen
Other descriptive name: B/ -LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: A/ (H3N2) - like virus antigen
Other descriptive name: A/ (H3N2)-LIKE VIRUS ANTIGEN
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number: 30-

Trade Name: Fluzone Quadrivalent
Product Name: Fluzone Quadrivalent (Influenza Virus Vaccine)
Product Code: Fluzone QIV
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: A/ (H1N1) like virus antigen
Other descriptive name: A/ (H1N1)-LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: A/ (H3N2) - like virus antigen
Other descriptive name: A/ (H3N2)-LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: B/ (Yamagata) - like virus antigen
Other descriptive name: B/ -LIKE VIRUS ANTIGEN
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 30-
INN or Proposed INN: B/ (Victoria) - like virus antigen
Other descriptive name: B/ -LIKE VIRUS ANTIGEN
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number: 30-

Primary Outcome(s)

Secondary Objective: Secondary Immunogenicity Objective:
To evaluate the antibody responses to heterologous influenza strains post vaccination with
aQIV or a non-adjuvanted comparator influenza vaccine in children previously vaccinated
in parent trial V118_05. Moreover, the comparison of the two treatment groups regarding
the immunogenicity variables will be carried out.

Primary end point(s): Primary safety endpoint: Percentage of subjects reporting SAEs, AEs leading to withdrawal from the study,
NOCDs, AESI and concomitant medications associated with these events as collected
from Day 1 through the Study Termination Visit.
Primary immunogenicity endpoint:
The following primary immunogenicity endpoints will examined for the homologous
strains for all cohorts at Days 1 and 22:
- Percentage of subjects achieving seroconversion.
- Percentage of subjects achieving HI titer >1:40.

Main Objective: Primary Immunogenicity Objective: To evaluate the antibody responses to homologous
(CBER criteria) influenza strains post vaccination with aQIV or a non-adjuvanted
comparator influenza vaccine in children previously vaccinated in parent trial V118_05.
Primary Safety Objective: To evaluate the safety of revaccination of aQIV or nonadjuvanted
comparator vaccine in children previously vaccinated in parent trial V118_05

Timepoint(s) of evaluation of this end point: Day 1 through Study Termination Visit.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Day 1 through Study Termination Visit.

Secondary end point(s): The secondary measures for assessing safety and tolerability are as follows:
- Percentage of subjects with solicited local and systemic AEs and other solicited
data as measured for 7 days following vaccination.
- Percentage of subjects with any unsolicited AEs reported will be assessed from
Day 1 through Day 22.
- Percentage of children with a diagnosis of failure to thrive or short stature
collected from Day 1 through the Study Termination Visit.

Secondary ID(s)

V118_05E1

Source(s) of Monetary Support

Novartis Pharma Services AG