Please select the outcome measures that correspond to the clinical trial below.
Title: N/A
Brief Summary: The primary objective of this trial is to demonstrate the equivalence, in terms of immunogenicity, of three different industrial lots of the investigational vaccine thereby supporting consistency of the manufacturing process.

Secondary Objectives:

Immunogenicity

To demonstrate that the investigational vaccine induces an immune response at least as good as the one induced by the reference vaccine, in terms of antibody titers.

To assess the immunogenicity of the investigational vaccine using parameters defined in the European Medicines Agency (EMEA) Note for Guidance (CPMP/BWP/214/96).

Safety:

To demonstrate that the investigational vaccine is at least as well tolerated as the reference vaccine, in terms of defined safety profile.

To describe the safety profile after vaccination.

Comfort of the vaccination assessment:

To assess the pain immediately after the injection using a Verbal Rating Scale. To describe the vaccination comfort after the injection using a -Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire.


Options:
A: To provide information concerning the immunogenicity of an inactivated, split-virion influenza vaccine (21 Days pot-vaccination)
B: Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Titers for Serum H5N1 Haemagglutinin Inhibition (HI) Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroconverted Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Seroconversion Factor (SCF) for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 0); Number of Seroprotected Subjects for H5N1 HI Antibodies Against the A/Indonesia/05/2005 Strain (At Day 21); Number of Subjects With Any and Grade 3 Solicited Local Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms (During the 7-day (Days 0-6) post-vaccination period following each dose and across doses); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 21-day (Days 0-20) follow-up period after the first vaccination and 30-day (Days 0-29) follow-up period after the second vaccination); Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) (During the 30-day (Days 0-29) follow-up period after the first vaccination); Number of Subjects With Serious Adverse Events (SAEs) (During the entire study period (From Day 0 up to Month 24))
C: Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. (Up to 6 days after each vaccination.); Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine. (Upto Day 224 post vaccination)
D: Number of Participants With Reactogenicity (Solicited) Adverse Events (AEs) (Reactogenicity days 0-7 following immunization; other AEs days 0-28 following immunization)

Answer: A