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| Name | Class |
|---|---|
| National Institute of Hygiene and Epidemiology, Vietnam | OTHER |
| World Health Organization | OTHER |
| Department of Health and Human Services | FED |
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The study hypothesis was that two 0.5 mL doses of whole virion monovalent A/H5N1 influenza vaccine (IVACFLU-A/H5N1) adjuvanted with alum would be safe and well tolerated in healthy adults, and that at least one of the two doses tested would be immunogenic in 60% or more of the subjects tested.
Although the A/H1N1 (2009) pandemic has subsided and the virus has become endemic, the threat of another pandemic due to avian influenza A/H5N1 remains constant. Since 1997, highly pathogenic A/H5N1 avian viruses have caused both widespread outbreaks in poultry with high mortality and sporadic, severe, and fatal disease in humans. Southeast Asian countries, including Vietnam, have been affected by influenza A/H5N1. From 2003 through March 2015, WHO has reported 826 confirmed human cases of A/H5N1 influenza infection; including 440 fatal cases (World Health Organization, 2015). Southeast Asian countries accounted for 42% of all confirmed influenza A/H5N1 cases reported since 2003, and influenza A/H5N1 infection in animals is now thought to be endemic in the region (World Health Organization, 2015). As of March 2015, Vietnam has reported 127 confirmed human cases and 64 deaths. In 2014, two cases of A/H5N1 avian influenza were reported in Vietnam. Therefore, the risk of transmission to human is still present.
At the time of the study, no influenza A/H5N1 vaccine had been licensed in Vietnam. IVACFLU-A/H5N1 is an influenza A/H5N1 vaccine produced by Institute of Vaccines and Medical Biologicals (IVAC) using embryonated chicken eggs. IVACFLU-A/H5N1 is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge (Alfa Wassermann, West Caldwell, NJ) and inactivated with formaldehyde. The vaccine is alum adjuvanted. Vaccine strain NIBRG-14 derived from original influenza A/Vietnam/1194/2004 was provided to IVAC by the National Institute for Biological Standards and Control of the Health Protection Agency of the United Kingdom. A clinical trial of IVACFLU-A/H5N1 vaccine conducted in 75 subjects at the Ben Luc Health District in Vietnam in 2014 showed that the vaccine is safe and immunogenic at doses of 7.5 and 15 mcg.
This study was conducted in two stages: Phase 2 was a dose selection study where subjects were randomized to one of the three groups (15 mcg IVACFLU-A/H5N1 vaccine, 30 mcg IVACFLU-A/H5N1 vaccine or placebo) at a 1:1:1 ratio. The conduct of Phase 3 was dependent on showing hemagglutination inhibition (HAI) response titer of ≥1:40 in ≥60% of vaccine recipients in at least one of the two Phase 2 IVACFLU-A/H5N1 vaccine groups. Based on the review of immunogenicity and safety results from the Phase 2 study, a dose of study vaccine was selected for Phase 3. Subjects were randomized at two sites (Khanh Hoa and Hai Phong) to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 or placebo . Safety was assessed in all subjects and immunogenicity was measured in a subset of subjects at the Hai Phong study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: Placebo | Placebo Comparator | Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
|
| Phase 2: Vaccine (15 mcg) | Active Comparator | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
|
| Phase 2: Vaccine (30 mcg) | Active Comparator | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
|
| Phase 3: Placebo | Placebo Comparator | Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
|
| Phase 3: Vaccine | Experimental | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVACFLU-A/H5N1 vaccine | Biological | Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative. |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 1, Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Minor out-of-range laboratory values no greater than Grade 1 were not considered to be exclusionary at screening.
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| Name | Affiliation | Role |
|---|---|---|
| Tran N Duong, MD, PhD | National Institute of Hygiene and Epidemiology, Vietnam | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 3: Hai Phong Provincial Preventive Medicine Center | Haiphong | Hai Phong | Vietnam | |||
| Phase 2 & 3: Khanh Hoa Provincial Health Department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31812464 | Derived | Duong TN, Thiem VD, Anh DD, Cuong NP, Thang TC, Huong VM, Chien VC, Phuong NTL, Montomoli E, Holt R, Scorza FB, Flores J, Tewari T. A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1). Vaccine. 2020 Feb 5;38(6):1541-1550. doi: 10.1016/j.vaccine.2019.11.059. Epub 2019 Dec 4. |
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Phase 2 & 3: Recruitment occurred from communes affiliated with the District Health Centers. Commune health workers identified potential participants through home visits and invited interested people to attend an information session. People heard about the study and those interested had individual consent for screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2: Placebo | Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| FG001 | Phase 2: Vaccine (15 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| FG002 | Phase 2: Vaccine (30 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| FG003 | Phase 3: Placebo | Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| FG004 | Phase 3: Vaccine | Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phase 2 |
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| ||||||||||||||||||||||||||||||
| Phase 3 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2: Placebo | Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| BG001 | Phase 2: Vaccine (15 mcg) |
| 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 and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 1, Day 43 |
|
21 days for non-serious adverse events, 90 days for serious adverse events
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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 | Phase 2: Placebo | Subjects participating in Phase 2 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal adhesion | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Le Van Be | IVAC | (+84 90) 3501529 | ivaclevabe@dng.vnn.vn |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 22, 2015 | Oct 29, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Nov 24, 2015 | Oct 29, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| PATH |
| OTHER |
| FHI 360 | OTHER |
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|
|
| Placebo | Biological | Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate. |
|
|
| Day 1, Day 22 |
| Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 22, Day 43 |
| Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 43 |
| Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 1, Day 22, Day 43 |
| Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 1, Day 43 |
| Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1 | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 22, Day 43 |
| Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 43 |
| Number and Percentage of Subjects Experiencing Reactogenicity | Immediate reactogenicity (30 minutes post-injection) were evaluated on Day 1 and Day 22 and consisted of:
Immediate reactogenicity were assessed by a study physician or appropriately trained medical staff. | 30 minutes after each injection |
| Number and Percentage of Subjects Experiencing Reactogenicity | Reported solicited signs and symptoms were recorded by the subject on the Diary Card from Days 1-7 and Days 22-28 in the study, then evaluated by study physician on Days 8, 22, and 29.The evaluated solicited local reactogenicity events were as follows:
The evaluated solicited systemic reactogenicity events were as follows:
| 7 days after each vaccination |
| Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE) | Unsolicited AEs were any AEs that occurred any time after study product was given (temporally related to study product), whether or not deemed "related" to the product, and were not solicited. Unsolicited AEs were either observed by study staff while the subject was at a clinic for a study visit or reported by the subject at any time. Any solicited sign or symptom starting after 7 days post-study product injection was recorded as an "unsolicited AE". For the Phase 2 study, laboratory results were considered AEs when the result was Grade 2 or above. Any medical condition that was present at the time that the subject was enrolled was not reported as an AE, but was reported as a pre-existing condition on the Medical History Form. However, if this condition occurred with greater frequency or severity during the study, it was recorded as an AE. | 21 days after each vaccination |
| Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE) | Defined as an adverse event that led to death, was life-threatening (subject at immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in congenital anomaly/birth defect; resulted in a persistent or significant disability or incapacity. | 90 days |
| Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Day 22, Day 43 |
| Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer | The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo. | Day 43 |
| Phase 2: Geometric Mean Neutralizing Antibody Titer | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Day 1, Day 22, Day 43 |
| Phase 3: Geometric Mean Neutralizing Antibody Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Day 1, Day 43 |
| Phase 2: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1 | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Day 22, Day 43 |
| Phase 3: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1 | The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo. | Day 43 |
| Nha Trang |
| Khanh Hoa |
| Vietnam |
| Pregnancy |
|
| Received Injection 1 |
|
| Received Injection 2 |
|
| Completed Day 29 Clinic Visit |
|
| Completed Day 43 Clinic Visit |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days.
| BG002 | Phase 2: Vaccine (30 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| BG003 | Phase 3: Placebo | Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| BG004 | Phase 3: Vaccine | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Phase 2: Vaccine (15 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| OG002 | Phase 2: Vaccine (30 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
| OG003 | Phase 3: Placebo | Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. |
| OG004 | Phase 3: Vaccine | Subjects participating in Phase 3 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. |
|
|
| Secondary | Phase 2: Number and Percentage of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer of ≥1:40 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 1, Day 22 |
|
|
|
| Secondary | Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 43 |
|
|
|
| Secondary | Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 43 |
|
|
|
| Secondary | Phase 2: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1 | Serum specimens were tested for the presence of HAI antibodies to influenza on day 1, day 22, and day 43 (day 1 and 22 prior to injection). The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | fold change | Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Geometric Mean Hemagglutination Inhibition (HAI) Titer Ratio, With Respect to Day 1 | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | fold change | Day 43 |
|
|
|
| Secondary | Number and Percentage of Subjects Experiencing Reactogenicity | Immediate reactogenicity (30 minutes post-injection) were evaluated on Day 1 and Day 22 and consisted of:
Immediate reactogenicity were assessed by a study physician or appropriately trained medical staff. | Subjects who received injections | Posted | Count of Participants | Participants | 30 minutes after each injection |
|
|
|
| Secondary | Number and Percentage of Subjects Experiencing Reactogenicity | Reported solicited signs and symptoms were recorded by the subject on the Diary Card from Days 1-7 and Days 22-28 in the study, then evaluated by study physician on Days 8, 22, and 29.The evaluated solicited local reactogenicity events were as follows:
The evaluated solicited systemic reactogenicity events were as follows:
| Subjects who received injections | Posted | Count of Participants | Participants | 7 days after each vaccination |
|
|
|
| Secondary | Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE) | Unsolicited AEs were any AEs that occurred any time after study product was given (temporally related to study product), whether or not deemed "related" to the product, and were not solicited. Unsolicited AEs were either observed by study staff while the subject was at a clinic for a study visit or reported by the subject at any time. Any solicited sign or symptom starting after 7 days post-study product injection was recorded as an "unsolicited AE". For the Phase 2 study, laboratory results were considered AEs when the result was Grade 2 or above. Any medical condition that was present at the time that the subject was enrolled was not reported as an AE, but was reported as a pre-existing condition on the Medical History Form. However, if this condition occurred with greater frequency or severity during the study, it was recorded as an AE. | Subjects who received injections | Posted | Count of Participants | Participants | 21 days after each vaccination |
|
|
|
| Secondary | Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE) | Defined as an adverse event that led to death, was life-threatening (subject at immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in congenital anomaly/birth defect; resulted in a persistent or significant disability or incapacity. | Subjects who received injections | Posted | Count of Participants | Participants | 90 days |
|
|
|
| Secondary | Phase 2: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Number and Percentage of Subjects Achieving at Least a 4-fold Increase in Neutralizing Antibody Titer | The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Count of Participants | Participants | Day 43 |
|
|
|
| Secondary | Phase 2: Geometric Mean Neutralizing Antibody Titer | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Geometric Mean Neutralizing Antibody Titer | Serum specimens were tested for the presence of HAI antibodies to influenza. The HAI assay was conducted using serum samples from all the subjects in Phase 2 of the study and in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in Phase 3 in order to have at least 200 evaluable subjects receiving IVACFLU-A/H5N1 and 40 evaluable subjects receiving placebo, at the end of study. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 1, Day 43 |
|
|
|
| Secondary | Phase 2: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1 | The microneutralization (MN) assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. | Subjects who received the prior injections (as applicable) and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | fold change | Day 22, Day 43 |
|
|
|
| Secondary | Phase 3: Geometric Mean Neutralizing Antibody Titer Ratio, With Respect to Day 1 | The MN assay is an alternative assay for determining immunologic response to vaccination. It is a highly sensitive assay that can provide information on the ability of induced antibody to neutralize influenza virus. Titers of neutralizing antibodies were expressed as the amount of the greatest dilution of serum giving a neutralization of 50% of tissue cytopathic effects of the virus in the tissue culture. In Phase 3, MN assay was conducted in a subset of approximately 270 subjects receiving the IVACFLU-A/H5N1 vaccine (vaccinees) and placebo from one study site in order to have at least 200 evaluable subjects receiving IVACFLU A/H5N1 and 40 evaluable subjects receiving placebo. | Subjects who received 2 injections and had valid sera samples for the day measured | Posted | Geometric Mean | 95% Confidence Interval | fold change | Day 43 |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 21 |
| 100 |
| EG001 | Phase 2: Vaccine (15 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. | 0 | 100 | 1 | 100 | 20 | 100 |
| EG002 | Phase 2: Vaccine (30 mcg) | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (30 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. | 0 | 100 | 0 | 100 | 24 | 100 |
| EG003 | Phase 3: Placebo | Subjects participating in Phase 3 and assigned to receiving two injections of placebo administered intramuscularly as a single dose, separated by 21 days. | 0 | 105 | 4 | 105 | 17 | 105 |
| EG004 | Phase 3: Vaccine | Subjects participating in Phase 2 and assigned to receiving two injections of IVACFLU-A/H5N1 vaccine (15 mcg concentration) administered intramuscularly as a single dose, separated by 21 days. | 0 | 525 | 8 | 525 | 58 | 525 |
| Abdominal symptom | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Electric shock | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral fever | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periodontal inflammation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vestibular disorder | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinitis allergic | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue 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 |
|
| Tonsillitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (Unspecified) | Systematic Assessment |
|
| Vestibular disorder | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal symptom | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Oropharyngeal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Burning sensation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Urticaria | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gingivitis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gout | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Back pain | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertigo | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Laryngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Herpes Zoster | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection site bruising | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Refraction disorder | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pharyngitis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Cervicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Sebaceous gland infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Abdominal adhesion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Electric shock | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Pyelonephritis | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Subcutaneous abscess | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
Not provided
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Day 22 |
|
|
| Day 43 |
|
|
| Day 43 |
|
|
|
| Injection 1: any systemic reaction |
|
|
| Injection 2: any local reaction |
|
|
| Injection 2: any systemic reaction |
|
|
|
| Injection 1: any systemic reaction |
|
|
| Injection 2: any local reaction |
|
|
| Injection 2: any systemic reaction |
|
|
|
| Injection 1: at least 1 severe AE |
|
|
| Injection 1: at least 1 treatment-related AE |
|
|
| Injection 2: at least one AE |
|
|
| Injection 2: at least 1 severe AE |
|
|
| Injection 2: at least 1 treatment-related AE |
|
|
| Title | Measurements |
|---|---|
|
| Day 22 |
|
|
| Day 43 |
|
|
| Day 43 |
|
|