Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.
Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.
Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).
Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain
Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.
Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.
Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28
Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Titers were presented as geometric mean titers (GMTs).
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)
Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain
Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Medically-attended Events (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Number of Subjects With Potential Immune-mediated Disease (pIMDs)
Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.