Prophylaxis for influenza virus MedDRA version: 18.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
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:
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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.;Timepoint(s) of evaluation of this end point: Day 1 through Study Termination Visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: Day 1 through Study Termination Visit. | — |
Countries
Finland, United States
Contacts
Public ContactFilippo Pacciarini
Novartis Vaccines Influenza S.r.l.
Outcome results
None listed