The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in Children 6 to <72 months of age, Mexican population, in comparison to Fluzone, a non adjuvanted Trivalent Influenza Vaccine (TIV).

• Register: EUCTR
• Last refreshed on: 27 October 2014
• Main ID: EUCTR2014-004248-36-Outside-EU/EEA
• Date of registration: 14/10/2014
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in Children 6 to <72 months of age, Mexican population, in comparison to Fluzone, a non adjuvanted Trivalent Influenza Vaccine (TIV).
• Scientific title: A phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico. - V70_50
• Target sample size: 282
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-004248-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Mexico

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

• Name: Clinical Trial Information Desk
• Affiliation: Novartis Pharma Services AG

Key inclusion & exclusion criteria

Inclusion criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
1. Individuals of >6 months through <72 months of age on the day of informed consent.
2. Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Individuals who can comply with study procedures.
4. Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Are the trial subjects under 18? yes
Number of subjects for this age range: 282
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:
Each subject must not have:
1. Progressive, unstable or uncontrolled clinical conditions.
2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
3. History of progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
4. Surgery planned during the study period that in the Investigator’s opinion would interfere with the study visits schedule.
5. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
6. Any fatal prognosis of an underlying medical condition (<12 month life expectancy).
7. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
8. Abnormal function of the immune system resulting from:
a. Clinical conditions.
b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
9. Received immunoglobulins or any blood products within 180 days prior to informed consent.
10. Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
11. Study personnel as an immediate family or household member.
12. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
13. Received any influenza vaccine (licensed or investigational) or with laboratory
confirmed influenza within 6 months prior enrollment.
14. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.


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

Health Condition(s) or Problem(s) studied

Influenza

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

Trade Name: Fluad
Pharmaceutical Form: Suspension for injection

Trade Name: Fluzone
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 1. from day 1 to day 7 following each vaccination;
2. from day 1 to day 50 (vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects);
3. from day 1 to day 50 (naïve subjects), from day 1 to day 22 (non-naïve subjects).
4. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects),

Main Objective: 1. To assess the safety of aTIV and TIV vaccines administered to healthy subjects 6 to <72 months of age, from day 1 to day 50 (naïve subjects) and from day 1 to day 22 (non-naïve subjects).
2. To demonstrate non-inferiority of aTIV to TIV as measured by geometric mean titers (GMTs) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.

Primary end point(s): 1. Percentage of subjects reporting solicited local and systemic AEs from day 1 to
day 7 following each vaccination;
2. Percentage of subjects reporting all unsolicited AEs from day 1 to day 50
(vaccine naïve subjects), from day 1 to day 22 (non-naïve subjects);
3. Percentage of subjects reporting medically attended AEs (MAAEs), AEs leading
to study withdrawal and SAEs from day 1 to day 50 (naïve subjects), from day 1
to day 22 (non-naïve subjects).
4. GMTs on day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects), as
applicable.

Secondary Objective: 1. To evaluate non-inferiority of aTIV to TIV as measured by % of subjects with
seroconversion in all three homologous virus strains, 21 days after last
immunization, in subjects 6 to <72 months of age.
2. To evaluate the immunogenicity of aTIV and TIV as measured by GM ratios
(GMRs), % of subjects with HI titers = 40, =110 and > 330 in all three homologous
virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
3. If non-inferiority will be established, to evaluate the GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization, in
subjects 6 to <72 months of age, using margins greater than the non-inferiority cutoff of 0.67.

Secondary Outcome(s)

Secondary end point(s): 1. Percentage of subjects achieving seroconversion defined as: HI = 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer =10, on day 22 (non-naïve subjects) or day 50 (naïve subjects), as applicable;
2. Day 22/day 1 (non-naïve subjects) or day 50/day 1 (naïve subjects) GMRs of HI, as applicable;
3. Percentage of subjects with a HI titer = 40, =110 and =330 on day 1, day 22
(non-naïve subjects) or day 50 (naïve subjects), as applicable.

Timepoint(s) of evaluation of this end point: 1. day 22 (non-naïve subjects) or day 50 (naïve subjects);
2. day 1 and day 22 (non-naïve subjects) or day 50 (naïve subjects);
3. day 1, day 22 (non-naïve subjects) or day 50 (naïve subjects).

Secondary ID(s)

V70_50

Source(s) of Monetary Support

Novartis Pharma Services AG