Influenza
Conditions
Keywords
Influenza
Brief summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Detailed description
All currently licensed influenza vaccines in the United States are produced in embryonated hen's eggs. There are several well-recognized disadvantages to the use of eggs as the substrate for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic. It is usually necessary to adapt candidate vaccine viruses for high-yield growth in eggs, a process that can be time consuming, is not always successful, and can select receptor variants that may have suboptimal immunogenicity. In addition, agricultural diseases that affect chicken flocks, and that might be an important issue in a pandemic due to an avian influenza virus strain, could easily disrupt the supply of eggs for vaccine manufacturing. Therefore, development of alternative substrates for influenza vaccine production has been identified as a high-priority objective. One potential alternative method for production of influenza vaccine is expression of the influenza virus hemagglutinin (HA) using recombinant DNA techniques. This alternative avoids dependence on eggs and is very efficient because of the high levels of protein expression under the control of the baculovirus polyhedrin promoter.
Interventions
BIOLOGICALPanblok
Intramuscular injection
BIOLOGICALrHA adjuvant
Intramuscular injection
Sponsors
Protein Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults, regardless of gender, aged 18 years and above 2. Able to give written informed consent to participate. 3. Body temperature \<100.0ºF. 4. The subject must be in reasonably good health as determined by targeted physical examination, when necessary, based on medical history. 5. Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 24 hours preceding receipt of first and second vaccine doses. 6. Women are considered not of child-bearing potential if they are: * Surgically sterile * Menopausal, defined as no natural menses for ≥12 months 7. Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits and remote contacts.
Exclusion criteria
1. Persons who previously received an H5N1 or H7N9 influenza vaccine or who plan to receive an H5N1or H7N9 influenza vaccine while participating in the study. 2. Persons who plan to receive a seasonal influenza vaccine earlier than Day 42 of participation in this study, i.e. before the post-vaccination serology sample is obtained. 3. Persons with an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of immune responses. 4. Persons taking medications or treatments that may adversely affect the immune system, e.g. cytotoxic agents, immunosuppressive doses of corticosteroids, anti-TNFα agents. 5. Persons with an active neoplastic disease (excluding non-melanoma skin cancer that was successfully treated) or a history of any hematological malignancy. For this criterion, active is defined as having received treatment within the past 5 years. 6. Persons with a history of documented autoimmune disease. 7. Women currently pregnant, nursing mothers or women planning a pregnancy between enrollment and 42 days after randomization. 8. Persons who have had a prior serious reaction to any influenza vaccine. 9. Persons with a known history of Guillain-Barré Syndrome (GBS). 10. Persons with a history of anaphylactic-type reaction to injected vaccines. 11. Persons with a history of illicit drug use or alcohol abuse that may compromise the subject's ability to comply with the protocol. 12. Persons who received a seasonal influenza vaccine \< 6 months prior to enrollment (may delay enrollment). 13. Persons who received any licensed inactivated or recombinant (non-live) vaccine within 2 weeks prior to enrollment or any licensed live vaccine within 1 month prior to enrollment (may delay enrollment) (See separate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 42 Days | The primary endpoint will be seroprotection rate to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days | Solicited events of local and systemic reactogenicity Days 0-7 |
| Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | 13 months | — |
| Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | 42 Days | Unsolicited adverse events (UAEs) Days 0-42. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Panblok 7.5µg in 2% SE 7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection | 95 |
| Panblok 15µg in 2% SE 15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection | 94 |
| Panblok 30µg in 2% SE 30µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection
rHA adjuvant: Intramuscular injection | 99 |
| Panblok 30µg (No Adjuvant) 30µg recombinant hemagglutinin (no adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle
Panblok: Intramuscular injection | 94 |
| Total | 382 |
Baseline characteristics
| Characteristic | Panblok 7.5µg in 2% SE | Panblok 15µg in 2% SE | Panblok 30µg in 2% SE | Panblok 30µg (No Adjuvant) | Total |
|---|---|---|---|---|---|
| Age, Customized Age, Categorical <65 Years | 45 Participants | 45 Participants | 49 Participants | 42 Participants | 181 Participants |
| Age, Customized Age, Categorical >=65 Years | 50 Participants | 49 Participants | 50 Participants | 52 Participants | 201 Participants |
| Sex: Female, Male Female | 62 Participants | 54 Participants | 56 Participants | 61 Participants | 233 Participants |
| Sex: Female, Male Male | 33 Participants | 40 Participants | 43 Participants | 33 Participants | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 101 | 0 / 102 | 1 / 97 |
| other Total, other adverse events | 0 / 100 | 0 / 101 | 0 / 102 | 0 / 97 |
| serious Total, serious adverse events | 4 / 100 | 4 / 101 | 3 / 102 | 2 / 97 |
Outcome results
Primary
Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic.
The primary endpoint will be seroprotection rate to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Time frame: 42 Days
Population: Modified Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Panblok 7.5µg in 2% SE | Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 11 Participants |
| Panblok 15µg in 2% SE | Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 9 Participants |
| Panblok 30µg in 2% SE | Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 15 Participants |
| Panblok 30µg (No Adjuvant) | Demonstrate That the Immunogenicity of Adjuvanted Panblok H7 rHA is Sufficient to Support Emergency Use Authorization in the Event of a Declared Pandemic. | 1 Participants |
Secondary
Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination
Time frame: 13 months
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Myocardial infarction | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Fracture malunion | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Arthralgia | 1 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cellulitis | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Angina unstable | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Upper limb fracture | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Rib fracture | 1 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | VIIth nerve paralysis | 1 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Syncope | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Sinus bradycardia | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Peripheral arterial occlusive disease | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cervicobrachial syndrome | 1 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteolysis | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Chest pain | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Suicide attempt | 0 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteoarthritis | 2 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Musculoskeletal pain | 1 Participants |
| Panblok 7.5µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Appendicitis | 1 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Appendicitis | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Angina unstable | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Myocardial infarction | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Sinus bradycardia | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Chest pain | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Peripheral arterial occlusive disease | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cellulitis | 1 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Rib fracture | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Upper limb fracture | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Arthralgia | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Fracture malunion | 1 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Musculoskeletal pain | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteoarthritis | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteolysis | 1 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cervicobrachial syndrome | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Syncope | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | VIIth nerve paralysis | 0 Participants |
| Panblok 15µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Suicide attempt | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Appendicitis | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cervicobrachial syndrome | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteoarthritis | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Musculoskeletal pain | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Angina unstable | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Syncope | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Fracture malunion | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Suicide attempt | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Myocardial infarction | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Rib fracture | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteolysis | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cellulitis | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Peripheral arterial occlusive disease | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Upper limb fracture | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Chest pain | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Sinus bradycardia | 1 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | VIIth nerve paralysis | 0 Participants |
| Panblok 30µg in 2% SE | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Arthralgia | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Suicide attempt | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | VIIth nerve paralysis | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Fracture malunion | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Chest pain | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Angina unstable | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Musculoskeletal pain | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Peripheral arterial occlusive disease | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteoarthritis | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Sinus bradycardia | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Osteolysis | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Arthralgia | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cervicobrachial syndrome | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Myocardial infarction | 1 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Syncope | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Cellulitis | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Rib fracture | 0 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Upper limb fracture | 1 Participants |
| Panblok 30µg (No Adjuvant) | Long-term Safety Assessed by Incidence of SAEs, NOCIs. AESs Over 12 Months Following Vaccination | Appendicitis | 0 Participants |
Secondary
Reactogenicity Immediately After Each Injection, Extending to Day 7
Solicited events of local and systemic reactogenicity Days 0-7
Time frame: 7 Days
Population: Reactogenicity Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Panblok 7.5µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After First Vaccination | 37 Participants |
| Panblok 7.5µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After Second Vaccination | 30 Participants |
| Panblok 15µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After Second Vaccination | 30 Participants |
| Panblok 15µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After First Vaccination | 33 Participants |
| Panblok 30µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After First Vaccination | 33 Participants |
| Panblok 30µg in 2% SE | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After Second Vaccination | 26 Participants |
| Panblok 30µg (No Adjuvant) | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After First Vaccination | 27 Participants |
| Panblok 30µg (No Adjuvant) | Reactogenicity Immediately After Each Injection, Extending to Day 7 | 7 Days After Second Vaccination | 18 Participants |
Secondary
Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine
Unsolicited adverse events (UAEs) Days 0-42.
Time frame: 42 Days
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Cardiac disorders | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | General disorders | 4 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Neoplasms benign, malignant and unspecified | 1 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Musculoskeletal and connective tissue disorders | 4 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Metabolism and nutrition disorders | 1 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Immune system disorders | 1 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Nervous system disorders | 3 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Vascular disorders | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Respiratory, thoracic and mediastinal disorders | 6 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Infections and infestations | 6 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Ear and labyrinth disorders | 1 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Endocrine disorders | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Skin and subcutaneous tissue disorders | 1 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Injury, poisoning and procedural complications | 3 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Gastrointestinal disorders | 5 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Eye disorders | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Reproductive system and breast disorders | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Investigations | 0 Participants |
| Panblok 7.5µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Psychiatric disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Investigations | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Psychiatric disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Metabolism and nutrition disorders | 1 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Skin and subcutaneous tissue disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Musculoskeletal and connective tissue disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Nervous system disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Neoplasms benign, malignant and unspecified | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Eye disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Gastrointestinal disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Ear and labyrinth disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | General disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Cardiac disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Respiratory, thoracic and mediastinal disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Immune system disorders | 0 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Infections and infestations | 6 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Reproductive system and breast disorders | 1 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Injury, poisoning and procedural complications | 3 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Endocrine disorders | 2 Participants |
| Panblok 15µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Vascular disorders | 1 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Cardiac disorders | 1 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Ear and labyrinth disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Endocrine disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Eye disorders | 1 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Gastrointestinal disorders | 2 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | General disorders | 1 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Immune system disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Infections and infestations | 4 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Injury, poisoning and procedural complications | 2 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Investigations | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Metabolism and nutrition disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Musculoskeletal and connective tissue disorders | 5 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Neoplasms benign, malignant and unspecified | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Nervous system disorders | 5 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Psychiatric disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Reproductive system and breast disorders | 0 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Skin and subcutaneous tissue disorders | 2 Participants |
| Panblok 30µg in 2% SE | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Vascular disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Investigations | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Ear and labyrinth disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Psychiatric disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Injury, poisoning and procedural complications | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Infections and infestations | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Cardiac disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Reproductive system and breast disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Immune system disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | General disorders | 2 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Gastrointestinal disorders | 4 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Respiratory, thoracic and mediastinal disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Eye disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Endocrine disorders | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Vascular disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Neoplasms benign, malignant and unspecified | 0 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Musculoskeletal and connective tissue disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Skin and subcutaneous tissue disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Nervous system disorders | 1 Participants |
| Panblok 30µg (No Adjuvant) | Unsolicited Adverse Events (UAEs) During Days 0-42 Following the First Administration of Study Vaccine | Metabolism and nutrition disorders | 0 Participants |