H7N9 Influenza
Conditions
Keywords
Influenza, H7N9, Vaccine
Brief summary
Evaluate the safety and immunogenicity of four different doses of H7N9 vaccination in adults between the ages of 18 years and 65 years.
Interventions
BIOLOGICALH7N9c low dose with adjuvant
BIOLOGICALH7N9c medium dose with adjuvant
BIOLOGICALH7N9c high dose with adjuvant
BIOLOGICALH7N9c high dose without adjuvant
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adult subject ages 18-64 years. 2. Individuals willing to provide written informed consent 3. Individuals in good health. 4. Individuals who can comply with study procedures and follow-up.
Exclusion criteria
1. Individuals with history of cognitive or behavioral impairment or psychiatric disease, 2. Individuals unable to understand and follow study procedures, 3. History of significant illness, 4. History of chronic medical condition or progressive disease, 5. Allergy to any vaccine component or adverse event related to a vaccine component, 6. Impairment/alteration of the immune system, 7. Presence of progressive or severe neurological disorder, 8. Pregnant or breast-feeding, 9. Female of Child-bearing potential unwilling to use acceptable method of birth control, 10. Presence of medically significant cancer, 11. Receipt of investigational product within 30 day prior to entry into the study, 12. History of previous or suspected illness from avian flu caused by H7N9 virus, 13. History of H7 vaccination, 14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination, 15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination, 16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination, 17. History of drug or alcohol abuse within the past 2 years, 18. Body Mass Index (BMI) greater than or equal to 35kg/m2, 19. Individuals conducting the study or their immediate family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 1 and 43 | Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination |
| Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) | Day 43 | Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination. |
| Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 43 | Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10. |
| Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 1 and 43 | Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination. |
| Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Day 1 to Day 43 | Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine. |
| Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Day 1 to Day 366. | The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Day 1 through Day 7 after each vaccination. | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 1 and 22 | Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination. |
| Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 and 366 | Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine. |
| Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) | Day 22 | GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination. |
| Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 22 | Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10. |
| Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 1 and 22. | Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination. |
| Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 and 366. | The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay. |
| Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 and 366 | GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination. |
| Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 and 366 | Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination. Seroconversion is defined as postvaccination HI titer\>40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum four-fold increase in titer for subjects with baseline titer\>1:10. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 6 centers in United States.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Low Dose + Adj Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart | 98 |
| Medium Dose + Adj Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart. | 104 |
| High Dose + Adj Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart. | 98 |
| High Dose + No Adj Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart. | 102 |
| TOTAL Total of all reporting groups | 402 |
| Total | 804 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative Reason | 2 | 1 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 3 | 4 | 0 |
| Overall Study | Unclassified | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 1 | 2 |
Baseline characteristics
| Characteristic | Low Dose + Adj | Medium Dose + Adj | High Dose + Adj | High Dose + No Adj | TOTAL |
|---|---|---|---|---|---|
| Age, Continuous | 38.3 year STANDARD_DEVIATION 13.1 | 40.3 year STANDARD_DEVIATION 12.5 | 42.6 year STANDARD_DEVIATION 13.1 | 43.4 year STANDARD_DEVIATION 12.9 | 41.2 year STANDARD_DEVIATION 13 |
| Sex: Female, Male FEMALE | 60 Participants | 57 Participants | 48 Participants | 53 Participants | 218 Participants |
| Sex: Female, Male MALE | 38 Participants | 47 Participants | 50 Participants | 49 Participants | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 71 / 98 | 87 / 103 | 79 / 98 | 62 / 102 | 299 / 401 |
| serious Total, serious adverse events | 2 / 98 | 2 / 103 | 3 / 98 | 1 / 102 | 8 / 401 |
Outcome results
Primary
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)
Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.
Time frame: Day 43
Population: FAS-Day 43
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Low Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) | 2.42 Ratio |
| Medium Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) | 3.7 Ratio |
| High Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) | 5.2 Ratio |
| High Dose + No Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43) | 1.14 Ratio |
Primary
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)
Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination
Time frame: Day 1 and 43
Population: The analysis was done on Full Analysis Set - Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 1 | 5 Titers |
| Low Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 43 | 12 Titers |
| Medium Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 43 | 19 Titers |
| Medium Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 1 | 5 Titers |
| High Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 1 | 5 Titers |
| High Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 43 | 26 Titers |
| High Dose + No Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 1 | 5.05 Titers |
| High Dose + No Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43) | Day 43 | 5.75 Titers |
Primary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Time frame: Day 1 through Day 7 after each vaccination.
Population: Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Local-Vaccination II | 39 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Pain | 34 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any systemic-Vaccination I | 40 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Arthralgia | 5 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Ecchymosis | 1 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Erythema | 11 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Myalgia | 8 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Induration | 9 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any local-Vaccination I | 47 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Systemic-Vaccination II (N=95,102,97,102) | 33 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Body Temp (≥38°C) | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Nausea | 10 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Nausea | 11 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Treatment of pain and (or)fever | 3 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Myalgia | 10 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Ecchymosis | 2 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Malaise | 8 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Arthralgia | 4 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Headache | 23 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Loss of appetite | 4 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Fatigue | 20 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Vomiting | 3 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Erythema | 11 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Diarrhea | 5 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Diarrhea | 10 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Loss of appetite | 4 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Pain | 42 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Vomiting | 1 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Malaise | 8 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Prevention of pain and/or fever | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I,Body Temp (≥38°C) | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Induration | 5 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Fatigue | 13 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Prevention of pain and/or fever | 3 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Treatment of pain and/or fever | 4 participants |
| Low Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Headache | 18 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Headache | 19 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Local-Vaccination II | 58 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Body Temp (≥38°C) | 2 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Arthralgia | 12 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Headache | 36 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Pain | 53 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Treatment of pain and (or)fever | 7 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Pain | 74 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Treatment of pain and/or fever | 12 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Ecchymosis | 3 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any systemic-Vaccination I | 56 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Myalgia | 16 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Fatigue | 32 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Erythema | 12 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any local-Vaccination I | 77 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Prevention of pain and/or fever | 1 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Diarrhea | 6 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Induration | 16 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Malaise | 25 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Nausea | 9 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Vomiting | 2 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Systemic-Vaccination II (N=95,102,97,102) | 37 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Prevention of pain and/or fever | 3 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Fatigue | 19 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Induration | 6 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Nausea | 12 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Diarrhea | 9 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Malaise | 17 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Erythema | 16 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Myalgia | 23 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Vomiting | 0 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I,Body Temp (≥38°C) | 1 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Loss of appetite | 10 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Arthralgia | 13 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Ecchymosis | 2 participants |
| Medium Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Loss of appetite | 10 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Induration | 4 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any local-Vaccination I | 60 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Pain | 53 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Ecchymosis | 2 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Erythema | 13 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Induration | 9 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any systemic-Vaccination I | 44 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Nausea | 8 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Myalgia | 13 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Arthralgia | 10 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Headache | 23 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Fatigue | 24 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Vomiting | 2 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Diarrhea | 6 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Loss of appetite | 11 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Malaise | 23 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I,Body Temp (≥38°C) | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Prevention of pain and/or fever | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Treatment of pain and/or fever | 3 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Local-Vaccination II | 46 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Pain | 45 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Ecchymosis | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Erythema | 6 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Systemic-Vaccination II (N=95,102,97,102) | 33 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Nausea | 9 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Myalgia | 14 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Arthralgia | 12 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Headache | 17 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Fatigue | 15 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Vomiting | 1 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Diarrhea | 4 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Loss of appetite | 7 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Malaise | 14 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Body Temp (≥38°C) | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Prevention of pain and/or fever | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Treatment of pain and (or)fever | 7 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Treatment of pain and/or fever | 3 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Prevention of pain and/or fever | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Body Temp (≥38°C) | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Headache | 11 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I,Body Temp (≥38°C) | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Malaise | 15 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Erythema | 11 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Fatigue | 15 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Loss of appetite | 4 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Diarrhea | 7 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Ecchymosis | 5 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Vomiting | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Vomiting | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Fatigue | 22 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Treatment of pain and (or)fever | 4 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Diarrhea | 8 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Headache | 20 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Arthralgia | 8 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Prevention of pain and/or fever | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Loss of appetite | 6 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Myalgia | 11 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Nausea | 5 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Pain | 19 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Malaise | 9 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Systemic-Vaccination II (N=95,102,97,102) | 25 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Induration | 6 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any systemic-Vaccination I | 42 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Nausea | 7 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Erythema | 9 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Ecchymosis | 4 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination I, Induration | 4 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Myalgia | 7 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Pain | 21 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any Local-Vaccination II | 27 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any local-Vaccination I | 30 participants |
| High Dose + No Adj | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Vaccination II, Arthralgia | 3 participants |
Primary
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.
Time frame: Day 1 to Day 43
Population: Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any AEs | 29 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related AEs | 6 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related AEs | 11 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any AEs | 31 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any AEs | 24 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related AEs | 7 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Any AEs | 24 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related AEs | 8 participants |
Primary
Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine
The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.
Time frame: Day 1 to Day 366.
Population: Analysis was done on unsolicited safety set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | SAEs | 2 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | NOCD | 1 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AESI | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related SAEs | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Death | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AEs leading to withdrawal | 0 participants |
| Low Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Medically attended AE | 33 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | NOCD | 7 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Medically attended AE | 43 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AEs leading to withdrawal | 0 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AESI | 0 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Death | 0 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related SAEs | 0 participants |
| Medium Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | SAEs | 2 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Medically attended AE | 34 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | SAEs | 3 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related SAEs | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AEs leading to withdrawal | 1 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AESI | 0 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | NOCD | 5 participants |
| High Dose + Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Death | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AEs leading to withdrawal | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Death | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | NOCD | 3 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | At least possibly related SAEs | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | SAEs | 1 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | AESI | 0 participants |
| High Dose + No Adj | Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine | Medically attended AE | 30 participants |
Primary
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Time frame: Day 43
Population: FAS-Day 43
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | 26 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | 44 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | 52 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | 3 Percentages of subjects |
Primary
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.
Time frame: Day 1 and 43
Population: FAS-Day 43.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 1 | 0 Percentages of subejcts |
| Low Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 43 | 26 Percentages of subejcts |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 43 | 44 Percentages of subejcts |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 1 | 0 Percentages of subejcts |
| High Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 1 | 0 Percentages of subejcts |
| High Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 43 | 52 Percentages of subejcts |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 1 | 0 Percentages of subejcts |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43) | Day 43 | 3 Percentages of subejcts |
Secondary
Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.
Time frame: Day 183 and 366
Population: FAS-Day 183 and FAS-Day 366
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183/Day 1 | 1.03 Ratio |
| Low Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366/Day 1 | 1 Ratio |
| Medium Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366/Day 1 | 1.03 Ratio |
| Medium Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183/Day 1 | 1.09 Ratio |
| High Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183/Day 1 | 1.2 Ratio |
| High Dose + Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366/Day 1 | 1.03 Ratio |
| High Dose + No Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183/Day 1 | 1.02 Ratio |
| High Dose + No Adj | Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366/Day 1 | 1.02 Ratio |
Secondary
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)
GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.
Time frame: Day 22
Population: FAS-Day 22
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Low Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) | 1.01 Ratio |
| Medium Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) | 1 Ratio |
| High Dose + Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) | 1 Ratio |
| High Dose + No Adj | Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22) | 1.01 Ratio |
Secondary
Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)
The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.
Time frame: Day 183 and 366.
Population: FAS-Day 183 and FAS-Day 366
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 | 5.17 Titers |
| Low Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366 (N=90,96,91,100) | 5 Titers |
| Medium Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366 (N=90,96,91,100) | 5.14 Titers |
| Medium Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 | 5.43 Titers |
| High Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 | 5.99 Titers |
| High Dose + Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366 (N=90,96,91,100) | 5.14 Titers |
| High Dose + No Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 183 | 5.16 Titers |
| High Dose + No Adj | Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence) | Day 366 (N=90,96,91,100) | 5.16 Titers |
Secondary
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)
Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.
Time frame: Day 1 and 22
Population: FAS-Day 22
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Low Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 1 | 5 Titers |
| Low Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 22 (N=96,103,97,102) | 5.07 Titers |
| Medium Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 22 (N=96,103,97,102) | 5 Titers |
| Medium Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 1 | 5 Titers |
| High Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 1 | 5 Titers |
| High Dose + Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 22 (N=96,103,97,102) | 5 Titers |
| High Dose + No Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 1 | 5.05 Titers |
| High Dose + No Adj | Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22) | Day 22 (N=96,103,97,102) | 5.1 Titers |
Secondary
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination. Seroconversion is defined as postvaccination HI titer\> 40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum 4-fold increase in titer for subjects with baseline titer \>1:10.
Time frame: Day 22
Population: FAS-Day 22
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | 0 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | 0 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | 0 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | 0 Percentages of subjects |
Secondary
Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination. Seroconversion is defined as postvaccination HI titer\>40 for subjects with baseline (day 1); HI titer \<1:10 or a minimum four-fold increase in titer for subjects with baseline titer\>1:10.
Time frame: Day 183 and 366
Population: FAS-Day 183 and FAS-Day 366
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 0 Percentages of subjects |
| Low Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 0 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 1 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 0 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 1 Percentages of subjects |
Secondary
Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)
Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.
Time frame: Day 1 and 22.
Population: FAS-Day 22
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 1 | 0 Percentages of subjects |
| Low Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 22 | 0 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 22 | 0 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 1 | 0 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 1 | 0 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 22 | 0 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 1 | 0 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22) | Day 22 | 1 Percentages of subjects |
Secondary
Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)
Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.
Time frame: Day 183 and 366
Population: FAS-Day 183 and FAS-Day 366
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Low Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 0 Percentages of subjects |
| Low Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 0 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 1 Percentages of subjects |
| Medium Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 0 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 183 | 1 Percentages of subjects |
| High Dose + No Adj | Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence) | Day 366 | 1 Percentages of subjects |