Influenza
Conditions
Keywords
GPO Tri Fluvac Vaccine, Tri Fluvac Vaccine
Brief summary
The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
Detailed description
This is a double blind randomized study consisting of two phases - Phase I and Phase II. The same vaccine, a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] will be given in both Phase I and Phase II of the study. The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total follow-up is 90 days. Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
Interventions
BIOLOGICALan inactivated influenza vaccine
The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
OTHERPlacebo
The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Sponsors
The Government Pharmaceutical Organization
World Health Organization
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy * Age 18-49 years old * Having Thai ID card or equivalent * All hematology, biochemistry and urine analysis are within normal range or of no clinical significance (not higher than 1.5 time of normal value without any clinical finding from history and physical examination) * Able to read and write and sign written informed consent form or assent form.
Exclusion criteria
* Known history of egg allergy * Having had recently influenza infection confirmed as H1N1, H3N2, or Flu B within 3 months preceding enrolment to the trial * Vaccination against influenza in the past 6 months preceding enrolment to the trial * History of bronchial asthma, chronic lung diseases, chronic rhinitis * History of immunodeficiency state * History of immunosuppression \< 6 months prior to immunization * History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal) * Acute infectious with fever \> 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrollment in the trial * The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the experiment * Participation in other research study * Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding * Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures * Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 90 days | All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | 90 days | Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40. |
| Geometric Mean of Immune Response at Every Time of Assessment | 90 days | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) |
| Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | 90 days | The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer \> 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II |
Participant flow
Pre-assignment details
A total of 340 participants (40 in phase I and 300 in phase II) who met all inclusion criteria and not of the exclusion criteria were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Inactivated Influenza Vaccine Phase I A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. | 20 |
| Placebo Phase I A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. | 20 |
| Inactivated Influenza Vaccine Phase II A single dose of a seasonal trivalent inactivated split virion influenza vaccine \[A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains\] 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. | 200 |
| Placebo Phase II A single dose of placebo (0.9% normal saline solution) 0.5 ml. was administered via the intramuscular route to the subjects at day 0 after blood collection for immunology assays. | 100 |
| Total | 340 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo Phase I | Inactivated Influenza Vaccine Phase II | Inactivated Influenza Vaccine Phase I | Placebo Phase II | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 200 Participants | 20 Participants | 100 Participants | 340 Participants |
| Age, Continuous | 28.15 years STANDARD_DEVIATION 6.72 | 32.28 years STANDARD_DEVIATION 8.19 | 32.25 years STANDARD_DEVIATION 9.45 | 32.2 years STANDARD_DEVIATION 7.96 | 31.22 years STANDARD_DEVIATION 8.43 |
| Region of Enrollment Thailand | 20 Participants | 200 Participants | 20 Participants | 100 Participants | 340 Participants |
| Sex: Female, Male Female | 5 Participants | 112 Participants | 10 Participants | 65 Participants | 192 Participants |
| Sex: Female, Male Male | 15 Participants | 88 Participants | 10 Participants | 35 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 200 | 0 / 100 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 200 | 0 / 100 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 200 | 0 / 100 |
Outcome results
Primary
Number of Participants With Adverse Events
All Adverse Events during 90 days will be analysed in terms of percentage and relationship to study vaccine
Time frame: 90 days
Population: All participants who receive at least one vaccination would be included in the safety population. The analysis will be conducted based on intent-to-treat (ITT) analysis. The population for the ITT analysis is defined as all individuals in the trial. The ITT analysis would include individuals who may not complete follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inactivated Influenza Vaccine Phase I | Number of Participants With Adverse Events | 5 Participants |
| Placebo Phase I | Number of Participants With Adverse Events | 8 Participants |
| Inactivated Influenza Vaccine Phase II | Number of Participants With Adverse Events | 69 Participants |
| Placebo Phase II | Number of Participants With Adverse Events | 30 Participants |
Secondary
Geometric Mean of Immune Response at Every Time of Assessment
The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90)
Time frame: 90 days
Population: The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 21 | 190.27 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 90 | 107.11 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 90 | 148.74 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 0 | 21.44 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 0 | 9.01 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 60 | 226.27 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 90 | 206.55 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 21 | 380.55 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 60 | 134.54 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 0 | 62.77 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 21 | 177.53 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 60 | 149.29 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 21 | 24.62 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 60 | 72.10 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 90 | 24.62 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 0 | 14.14 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 21 | 13.66 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 90 | 69.64 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 0 | 24.62 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 21 | 72.10 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 0 | 64.98 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 60 | 24.62 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 90 | 15.69 titer |
| Placebo Phase I | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 60 | 16.82 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 90 | 155.06 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 0 | 19.39 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 21 | 392.60 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 60 | 253.10 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 90 | 221.21 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 0 | 51.16 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 21 | 214.81 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 60 | 165.12 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 0 | 9.97 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 21 | 115.92 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 60 | 83.72 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 90 | 73.33 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 21 | 43.17 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 0 | 44.38 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 0 | 20.14 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 21 | 9.40 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 90 | 20.85 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 60 | 20.00 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 90 | 9.40 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 60 | 9.33 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 90 | 45.00 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H3N2 Day 60 | 43.17 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | A/H1N1 Day 21 | 20.00 titer |
| Placebo Phase II | Geometric Mean of Immune Response at Every Time of Assessment | B/Brisbane/60/2008 Day 0 | 9.20 titer |
Secondary
Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer
The analysis was performed only as intention-to-treat (ITT). The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0, 21, 60 and 90). Proportion of increased in GMT Titer \> 2.5 at each time of assessment compared with baseline (Day 0) was reported both phase I and phase II
Time frame: 90 days
Population: The antibody titer values were transformed into log10 titers for calculation of the GMT at every time of assessment (Days 0,21, 60 and 90) were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 21 | 21.11 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 90 | 2.31 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 90 | 12.85 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 day 21 | 2.83 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 90 | 9.26 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 60 | 10.56 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 60 | 14.93 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 60 | 2.38 titer |
| Inactivated Influenza Vaccine Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 21 | 17.75 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 60 | 1.11 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 21 | 0.97 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 90 | 1.07 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 60 | 1.00 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 21 | 1.00 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 90 | 1.00 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 90 | 1.11 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 60 | 1.19 titer |
| Placebo Phase I | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 day 21 | 1.11 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 60 | 3.19 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 21 | 20.25 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 60 | 13.06 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 90 | 11.45 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 day 21 | 4.20 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 90 | 3.03 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 21 | 11.63 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 60 | 8.40 titer |
| Inactivated Influenza Vaccine Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 90 | 7.33 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 21 | 1.02 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 day 21 | 0.97 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 90 | 1.04 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 90 | 1.02 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | B/Brisbane/60/2008 Day 60 | 1.01 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 60 | 0.99 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 90 | 1.01 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H3N2 Day 60 | 0.97 titer |
| Placebo Phase II | Geometric Mean of Immune Response Increase > 2.5 From Baseline of H1N1,H3N2 and B/Brisbane/60/2008 Antibody Titer | A/H1N1 Day 21 | 0.99 titer |
Secondary
Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer.
Seroconversion is defined as a 4-fold rise in HAI titer in post-immunization serum relative to pre-immunization serum, or if pre-immunization serum had an undetectable titer (\<1:10), attainment of a post-immunization titer of ≥1:40.
Time frame: 90 days
Population: Seroconversion against the hemagglutinin antigens contained in the vaccine were assessed in all studied participants both phase I and phase II. The analysis was performed as intention-to-treat (ITT).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 21 | 19 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 90 | 7 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 90 | 18 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 day 21 | 9 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 90 | 13 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 60 | 14 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 60 | 19 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 60 | 8 Participants |
| Inactivated Influenza Vaccine Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 21 | 17 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 60 | 1 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 21 | 0 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 90 | 1 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 60 | 0 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 21 | 0 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 90 | 0 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 90 | 1 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 60 | 2 Participants |
| Placebo Phase I | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 day 21 | 1 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 60 | 93 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 21 | 176 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 60 | 166 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 90 | 163 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 day 21 | 107 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 90 | 92 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 21 | 173 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 60 | 153 Participants |
| Inactivated Influenza Vaccine Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 90 | 146 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 21 | 1 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 day 21 | 0 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 90 | 1 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 90 | 1 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | B/Brisbane/60/2008 Day 60 | 1 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 60 | 0 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 90 | 2 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H3N2 Day 60 | 1 Participants |
| Placebo Phase II | Number (Percentage) of Participants With Achieving Seroconversions or Significant Increase in Antihemagglutinin Antibody Titer. | A/H1N1 Day 21 | 0 Participants |