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| Name | Class |
|---|---|
| Institute of Vaccines and Medical Biologicals, Vietnam | INDUSTRY |
| Pasteur Institute, Ho Chi Minh City | OTHER_GOV |
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The study hypothesis is that two 0.5 ml doses of non-adjuvanted whole virion monovalent A/H1N1 influenza vaccine (IVACFLU)--each dose with an HA content of 15 mcg from A/California/07/2009 (H1N1)-like virus--will be safe and immunogenic in healthy adults.
This is a phase I, double-blind, individually-randomized (1:1, vaccine:placebo), controlled trial with two groups, IVACFLU (A/H1N1) and placebo. Healthy male and female adults 18 through 40 years of age will be invited to participate. In addition to sponsor monitoring of safety, Program for Appropriate Technology in Health (PATH) will review safety data. Safety data through 7 days post-dose one for all subjects will be reviewed in a blinded fashion prior to administration of dose two of study vaccine or placebo. PATH will review all adverse events (AEs), including clinical laboratory evaluations (pre- and post-vaccination) and will advise if the volunteers may receive dose two of study vaccine or placebo. For all subjects, the procedures and timelines are summarized below.
On the day of first screening (S1), about 14 days (between 5 and 30 days) prior to administration of dose one of study vaccine or placebo, subjects will be screened for eligibility through medical history review, physical examination, testing for serologic evidence of chronic viral infection [human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)], routine biochemical and hematological blood tests and urinalysis by dipstick. For screening for serologic evidence of chronic viral infections, appropriate pre- and post-test counseling must be provided.
Subject screening for eligibility will continue and be completed on the second screening day (S2). This second screening day will occur the same day as scheduled enrollment into the trial and administration of study vaccine or placebo (Day 0). Women will undergo pregnancy tests using urine samples on Day 0. Fully eligible subjects will be enrolled into the trial. At that time, blood specimens will be collected for immunological testing prior to administration of study vaccine or placebo. Subjects will be unaware of which allocation, IVACFLU or placebo, is received; study vaccine and placebo will be masked. Subjects will be carefully monitored for adverse reactions for 60 minutes after vaccination.
During the first week following vaccination, subjects will be asked to record local and general signs and symptoms using preprinted diary cards, thermometer, and small ruler. Concomitant medications will also be recorded. In addition to solicited signs, subjects will be asked to report any other adverse events, whether or not they believe that the event is related to the vaccination. Member of the investigator's clinical team will visit subjects one and five days after vaccination to check that subjects are correctly completing the diary card and to check on the subjects' well-being. Subjects will then return to the study clinic 7 days after dose one. At that time, the investigator will check the subjects' diary cards and transcribe all adverse events onto the case report forms using medical language. Blood and urine specimens will also be collected for routine biochemical and hematological blood tests and urinalysis by dipstick.
Two days before subjects are scheduled to receive dose two, subjects will be visited or called to remind them of the next visit to the study clinic and to check on the subjects' well-being. Subjects will return to the study clinic at 3 weeks after administration of dose one of study vaccine or placebo in order to receive dose two. At that time, interim histories and concomitant medications will be reviewed. Women will again undergo urine pregnancy tests. All subjects will undergo collection of blood and urine specimens for routine biochemical and hematological blood tests and urinalysis by dipstick and collection of blood serum specimens for immunologic analyses. Then subjects will receive dose two of study vaccine or placebo and be monitored for 60 minutes.
After receipt of dose two, subjects will again complete diary cards for 7 days after vaccination with visits by members of the investigator's clinical team again at days one and five after vaccination to check that the subjects are correctly completing diary cards and to check on the subjects' well-being. Subjects will then return to the study clinic 7 days after dose two (Day 28) for review of diary cards by the investigator and collection of blood and urine specimens for routine biochemical and hematological blood tests and urinalysis by dipstick.
Two days before the subjects' next scheduled visit at 3 weeks after administration of dose two, subjects will be visited or called to remind them of the next visit to the study clinic and to check on the subjects' well-being. Subjects will then return to the study clinic at 3 weeks after administration of dose two (Day 42) of study vaccine or placebo for another study visit. At that time, interim histories and concomitant medications will again be reviewed and final blood specimens will be collected for immunogenicity analyses. Women will also undergo a final pregnancy screen.
Subjects will then be asked to immediately report severe adverse events (SAEs) which occur from Day 42 to Day 201 (approximately 6 months after receipt of dose two). To facilitate this reporting, a member of the investigator's team will visit or call the subjects monthly to check on their well-being. At last study visit on Day 201, subjects will be interviewed and examined one last time before completing the study.
For the evaluation of serum antibodies (by hemagglutination inhibition and microneutralization), serum specimens will be collected on Day 0 (prior to administration of dose one of study vaccine or placebo), on Day 21 (prior to administration of dose two of study vaccine or placebo) and on Day 42.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21 |
|
| Placebo | Placebo Comparator | Received placebo, administered intramuscularly, on days 0 and 21 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVACFLU | Biological | IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Maximum Systemic Reaction After Vaccination 1 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | 7 days |
| Number of Participants With Maximum Systemic Reaction After Vaccination 2 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | 7 days |
| Number of Participants With Maximum Local Reaction After Vaccination 1 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI) | Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Neuzil, MD, MPH | PATH | Study Director |
| Le V Be, MD, PhD | Institute of Vaccines and Medical Biologicals, Vietnam | Study Director |
| Ho V Thang, MD, MSc | Pasteur Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Luc Health Center | Bến Lức | Long An | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30337172 | Derived | Thang HV, Huong VM, Victor JC, Van CB, Nga NT, Be LV, Cuong NP, Tsvetnitsky V, Neuzil KM, Power M, Flores J. Safety and immunogenicity of inactivated monovalent influenza A/H1N1 vaccine candidate manufactured in Vietnam. Vaccine. 2018 Nov 12;36(46):6918-6925. doi: 10.1016/j.vaccine.2018.10.013. Epub 2018 Oct 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Vaccine | Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21 IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials. |
| FG001 | Placebo | Received placebo, administered intramuscularly, on days 0 and 21 Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Vaccine | Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21 IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Maximum Systemic Reaction After Vaccination 1 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | Posted | Count of Participants | Participants | 7 days |
|
7 days after each vaccination for non-serious adverse events; 201 days for serious adverse events.
Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Additionally, the participant recorded any serious adverse events over the entire study on clinic visits on day 42 and 201.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Influenza Vaccine | Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21 IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jorge Flores | PATH | (202) 822-0033 | jeflores@path.org |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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|
|
| Placebo | Other | Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials. |
|
| 7 days |
| Number of Participants With Maximum Local Reaction After Vaccination 2 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | 7 days |
| Unsolicited, Non-serious Adverse Events | Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Adverse events were collected throughout the study period, and were graded for severity; however unsolicited adverse events were assessed only for relationship to vaccine if the events were immediate reactions or considered to be serious adverse events. | 7 days after each dose (Day 7 and Day 28) |
| Day 0, Day 21 and Day 42 |
| Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI) | Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 0, Day 21 and Day 42 |
| Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 21 and Day 42 |
| Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40 | Day 21 and Day 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 21 and Day 42 |
| Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40 | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 21 and Day 42 |
| Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer | Seroprotection defined as an HAI titer ≥1:40. Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 21 and Day 42 |
| Geometric Mean Titer of Microneutralizing (MN) Antibodies | Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Day 0, Day 21 and Day 42 |
| Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies | Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Day 0, Day 21 and Day 42 |
| Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies | Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Day 21 and Day 42 |
| Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40 | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Day 21 and Day 42 |
| Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40 | Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Day 21 and Day 42 |
| Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer | Seroprotection defined as an antibody titer of 1:40 or greater. Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Day 21 and Day 42 |
| BG001 | Placebo | Received placebo, administered intramuscularly, on days 0 and 21 Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Handedness | Count of Participants | Participants |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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Received placebo, administered intramuscularly, on days 0 and 21
Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
| OG001 | Influenza Vaccine | Received 0.50 mL of inactivated monovalent influenza vaccine (IVACFLU), administered intramuscularly, on days 0 and 21 IVACFLU: IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials. |
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| Primary | Number of Participants With Maximum Systemic Reaction After Vaccination 2 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited systemic reactogenicity events included body temperature, feverishness, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion, convulsions/seizures, fatigue/malaise, muscle aches, joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting and jaundice. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | Posted | Count of Participants | Participants | 7 days |
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| Primary | Number of Participants With Maximum Local Reaction After Vaccination 1 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | Posted | Count of Participants | Participants | 7 days |
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| Primary | Number of Participants With Maximum Local Reaction After Vaccination 2 | Systemic and local reactogenicity data were collected on Study Days 0, 7, 21 and 28, prevaccination, and within 60 minutes post-vaccination by clinic staff. Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Solicited local reactogenicity included size of redness, size of swelling, size of induration, pain, and tenderness. | Posted | Count of Participants | Participants | 7 days |
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| Primary | Unsolicited, Non-serious Adverse Events | Subjects completed diary cards for 7 days after each vaccination and received visits from the investigator's clinical team at Days 1 and 5 following each vaccination. Adverse events were collected throughout the study period, and were graded for severity; however unsolicited adverse events were assessed only for relationship to vaccine if the events were immediate reactions or considered to be serious adverse events. | Posted | Number | adverse events | 7 days after each dose (Day 7 and Day 28) |
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| Secondary | Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI) | Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0, Day 21 and Day 42 |
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| Secondary | Ratio of Geometric Mean Titer of Hemagglutination-inhibition Antibodies (HAI) | Day 0, 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0, Day 21 and Day 42 |
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| Secondary | Number and Percentage of All Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Less Than 40 | Day 21 and Day 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Subjects with baseline titer <40 | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Number and Percentage of Subjects Achieving a Four-fold Rise in Hemagglutination-inhibition Antibodies (HAI) Among Subjects With Baseline Titer Greater Than 40 | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Subjects with baseline titer >=40 | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Number and Percentage of Subjects Developing a Seroprotective Hemagglutination-inhibition (HAI) Antibody Titer | Seroprotection defined as an HAI titer ≥1:40. Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Includes subjects who had a baseline titer of <1:40. | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Geometric Mean Titer of Microneutralizing (MN) Antibodies | Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 0, Day 21 and Day 42 |
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| Secondary | Ratio of Geometric Mean Titer of Microneutralization (MN) Antibodies | Day 0, 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Posted | Geometric Mean | 95% Confidence Interval | ratio | Day 0, Day 21 and Day 42 |
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| Secondary | Number and Percentage of All Subjects Achieving a Four-fold Rise in Microneutralization (MN) Antibodies | Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Less Than 40 | Day 21 and 42 blood samples from study subjects (n=48) were tested. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The hemagglutination titer was reported as the reciprocal of the highest dilution that caused hemagglutination and was expressed in HA units (HAU)/50μL, calculated as the average of results of duplicate wells. | Subjects with baseline titer <40 | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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| Secondary | Number and Percentage of Subjects Achieving a Four-fold Rise in Microneutralizing (MN) Antibodies Among Subjects With Baseline Titer Greater Than 40 | Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Subjects with baseline titer >=40 | Posted | Count of Participants | Participants | Day 21 and Day 42 |
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|
| Secondary | Number and Percentage of Subjects Developing a Seroprotective Microneutralizing (MN) Antibody Titer | Seroprotection defined as an antibody titer of 1:40 or greater. Day 21 and 42 specimens were tested in the microneutralization (MN) assay. The microneutralization assay determines the titer of neutralizing antibodies against influenza A/H1N1. The assay is performed in duplicate wells of 2-fold serial dilutions of serum. The 50% neutralizing antibody titer is the reciprocal of the corresponding serum dilution. The geometric mean titers (GMT) and corresponding confidence intervals were based on a log 10 scale. | Includes subjects who had a baseline titer of <1:40. | Posted | Count of Participants | Participants | Day 21 and Day 42 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 11 |
| 23 |
| EG001 | Placebo | Received placebo, administered intramuscularly, on days 0 and 21 Placebo: Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials. | 0 | 25 | 1 | 25 | 15 | 25 |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Generalized erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Piloerection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinitis allergic | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sciatica | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Moderate |
|
| Feverishness/subjective fever |
|
| Chills |
|
| Cough |
|
| Difficulty breathing |
|
| Runny nose |
|
| Nasal congestion |
|
| Sore throat |
|
| Hoarseness of voice |
|
| Headache |
|
| Confusion |
|
| Seizure |
|
| Fatigue/malaise |
|
| Muscle aches (generalized) |
|
| Joint pain |
|
| Pink or red eyes |
|
| Sore eyes |
|
| Itchy eyes |
|
| Drainage from eyes |
|
| Ear pain or discharge |
|
| Rash |
|
| Abdominal pain |
|
| Diarrhea |
|
| Vomiting |
|
| Jaundice |
|
| Swollen after injection |
|
| Red after injection |
|
| Hardness after injection |
|
| Painful feeling after injection |
|
| Pain when touching to the injection |
|
| Swollen after injection |
|
| Red after injection |
|
| Hardness after injection |
|
| Painful feeling after injection |
|
| Pain when touching to the injection |
|
| Day 42 |
|
| Day 42/Day 21 |
|
| Day 42 |
|
| Day 21 or 42 |
|
| Day 42 |
|
| Day 42 |
|
| Day 42 |
|
| Day 42 |
|
| Day 42/Day 21 |
|
| Day 42 |
|
| Day 21 or 42 |
|
| Day 42 |
|
| Day 42 |
|
| Day 42 |
|