Prophylaxis for influenza virus MedDRA version: 18.0 Level: PT Classification code 10022000 Term: Influenza System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Immunogenicity Objective: To evaluate the antibody responses as determined by CBER criteria to homologous influenza vaccine strains after vaccination with aQIV or a non-adjuvanted comparator influenza vaccine in children previously vaccinated in studies V118_05 and V118_05E1.;Secondary Objective: Secondary Immunogenicity Objectives: - To evaluate the antibody responses as determined by geometric mean titers (GMT) and geometric mean ratios (GMR) to homologous and heterologous influenza vaccine strains after vaccination with aQIV or a non-adjuvanted comparator influenza vaccine in children previously vaccinated in studies V118_05 and V118_05E1. - To compare the two treatment groups with regard to antibody response to homologous and heterologous influenza strains (GMT and GMR relative to Day1, percentage of subject’s achieving seroconversion (SC), as well as percentage of subjects achieving HI titer = 1:40). Secondary Safety Objective: - To evaluate the safety of revaccination of aQIV or non-adjuvanted comparator influenza vaccine in children previously vaccinated in trials V118_05 and V118_05E1.;Primary end point(s): Primary Immunogenicity Endpoint The following primary immunogenicity endpoints as measured by HI will be examined for the homologous strains within each of the two treatment groups at Day 22: - Percentage of subjects achieving seroconversion (SC). - Percentage of subjects achieving HI titer =1:40.;Timepoint(s) of evaluation of this end point: Immunogenicity endpoint: Day 22. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Immunogenicity Endpoint(s) Secondary immunogenicity endpoints as measured by HI for homologous and heterologous strains are: - Percentage of subjects achieving seroconversion (Day 181, for heterologous also at Day 22). - Percentage of subjects achieving titer =1:40 (Day 181, for heterologous also at Day 22). - GMTs on Days 22 and 181. - GMRs (Day 22: Day 1) and (Day 181: Day 1).Reverse cumulative distribution curves (Day 22 and Day 181). - - Reverse cumulative distribution curves (Day 22 and Day 181). The following endpoints as measured by HI for homologous and heterologous strains will be compared between the two treatment groups: - Difference between the proportions of subjects with seroconversion on Days 22 and 181. - Difference between the proportions of subjects with antibody titer =1:40 on Days 22 and 181. - Ratio of GMTs for the two treatment groups (GMTaQIV/GMTComp) on Days 22 and 181.;Timepoint(s) of evaluation of this end point: Immunogenicity endpoints: Days 1, 22, and 181. | — |
Countries
Finland, United States
Contacts
Public ContactFilippo Pacciarini
Novartis Vaccines Influenza s.r.l
Outcome results
None listed