Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003681-20 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| IQVIA Pty Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The study is a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, tolerability and immunogenicity of three doses of GBS NN/NN2 with Alhydrogel® (Recombinant protein vaccine against Group B Streptococcus) in elderly participants aged 55 to 75.Participants will be followed up to 6 months after last vaccination.
Sixty (60) healthy older adult participants aged 55 to 75 years will be randomised in two cohorts; 30 obese and/or diabetic participants aged 55 to 75 years will be randomised in two cohorts.
Participants will be involved in the study for approximately one year including screening and safety follow-up.
Eligible participants will be administered a dose of GBS-NN/NN2 or placebo on three occasions: the first dose will be administered on Day 1, followed by the second and third doses 4 and 24 weeks later, respectively.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - Active | Experimental | Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 1 - Placebo | Placebo Comparator | Cohort 1 (30 healthy older adult) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 2 - Active | Experimental | Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 2 - Placebo | Placebo Comparator | Cohort 2 (30 healthy older adult) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 3 - Active | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBS-NN/NN2 | Biological | GBS-NN/NN2 bound to alhydrogel as an adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine |
| Up to 28 days after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint). | Day 197 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Participants who have received a GBS vaccine previously.
Participants with history or presence of significant (as evaluated by the investigator) cardiovascular disease, pulmonary, hepatic, gallbladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, autoimmune disease or current infection.
NOTE: Patients with type 2 diabetes are to be recruited for Cohort 3 and Cohort 4.
Laboratory values at screening which are deemed by the investigator to be clinically significantly abnormal.
Current or history of drug or alcohol abuse per investigator judgement.
Positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
Participants currently participating in a clinical trial.
Participants receiving an investigational drug, vaccine or device during the 90 days preceding the initial dose in this study.
Any significant illness during the 4 weeks preceding the vaccination visit, per investigator judgement.
Participants with a history of severe allergic reactions after previous vaccination.
Participants who have received any vaccine within 30 days of first IMP administration, or who are planning to receive any vaccine (eg, travel vaccines) up to 30 days after each vaccination.
NOTE: Exceptions could be made for emergency vaccinations (eg, tetanus) or vaccination campaigns (eg, SARS, CoV-2 or influenza) which will be permitted not less than 7 days before or after study vaccination.
Participants receiving immunosuppressive therapy or immunoglobulins in the 6 months prior to screening.
Participants within a 7-day period after an acute infection in the 7 days preceding vaccination, as per investigator judgement, or with fever (oral temperature >37.9°C) in the 72 hours preceding vaccination.
Participants who have received antipyretics/analgesics treatment within 72 hours prior to dosing.
Participants on chronic medications that are likely to affect the assessments specified in the protocol (eg, anticoagulant therapy, systemic steroids).
NOTE: Chronic medications such as antihypertensives, bronchodilators, statins that do not affect the immune system, will be permitted and allowed to continue during the study at the discretion of the investigator. Treatment for diabetes will be continued as required for the diabetic participants recruited. Non-steroidal anti-inflammatory drugs or paracetamol will be permitted for the treatment of headache or other symptoms during the study. Use of over the counter (OTC) vitamins and dietary supplements is allowed.
Participants with skin defects and/or tattoos at the proposed site of vaccine administration.
Donation of blood or blood products within 90 days prior to first study vaccination.
Participants who, in the opinion of the Investigator, are unsuitable for participation in the study.
Involvement in the planning and/or conduct of the study (applies to both Sponsor personnel and/or personnel at the study centre or Clinical Research Organisation [CRO]).
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Geoff Kitson | gkitson@propharmapartners.uk.com | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent - Centrum voor Vaccinologie (CEVAC) department | Ghent | 9000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Overall, 90 participants were enrolled and randomised.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Older Adult : GBS-NN/NN2 50 µg | Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| FG001 | Healthy Older Adult : GBS-NN/NN2 125 µg | Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| FG002 | Healthy Older Adult : Placebo | Healthy older adult received three injections of placebo. Placebo: Normal Saline 0.9 % |
| FG003 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| FG004 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| FG005 | Obese and/or Diabetic Older Adult : Placebo | Obese and/or diabetic older adults received three injections of placebo. Placebo: Normal Saline 0.9 % |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Older Adult : GBS-NN/NN2 50 µg | Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| BG001 | Healthy Older Adult : GBS-NN/NN2 125 µg |
| 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 | Safety and Tolerability of the GBS-NN/NN2 Vaccine for 4 Weeks After Each Dose of Vaccine |
| Posted | Count of Participants | Participants | Up to 28 days after each vaccination |
|
All adverse events were collected from Day 1 until Day 57 and from Day 162 to Day 197. From Day 58 to Day 16 and from Day 198 to Day 365, only MAAEs, AESIs, and SAEs were collected.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Older Adult : GBS-NN/NN2 50 µg | Healthy older adult received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (26.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cornelia Oostvogels/Chief Medical Officer (CMO) | MinervaX | 00491515092821 | lio@minervax.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 11, 2023 | Aug 6, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 23, 2024 | Aug 6, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo).
|
| Cohort 3 - Placebo | Placebo Comparator | Cohort 3 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 4 - Active | Experimental | Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Cohort 4 - Placebo | Placebo Comparator | Cohort 4 (15 obese and/or diabetic older adults) will receive three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide in a 4:1 ratio (investigational medicinal product or placebo). |
|
| Placebo | Biological | Normal Saline 0.9 % |
|
| Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps |
Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination. |
| 4 weeks after each vaccination (Days 29, 57 and 197) |
| Seroconversion Rate at Any Time Post Vaccination | Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response. | Up to 6 months after last vaccination |
| Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (>1, >2, >4, and >8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose. | Up to day 197 |
| Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) |
| Up to day 365 |
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| BG002 | Healthy Older Adult : Placebo | Healthy older adult received three injections of placebo. Placebo: Normal Saline 0.9 % |
| BG003 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| BG004 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| BG005 | Obese and/or Diabetic Older Adult : Placebo | Obese and/or diabetic older adults received three injections of placebo. Placebo: Normal Saline 0.9 % |
| BG006 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Healthy Older Adult : GBS-NN/NN2 125 µg |
Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| OG002 | Healthy Older Adult : Placebo | Healthy older adult received three injections of placebo. Placebo: Normal Saline 0.9 % |
| OG003 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| OG004 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant |
| OG005 | Obese and/or Diabetic Older Adult : Placebo | Obese and/or diabetic older adults received three injections of placebo. Placebo: Normal Saline 0.9 % |
|
|
| Secondary | Geometric Mean Antibody Concentration in μg/mL for Antibodies to the Four Individual Alps | Geometric mean antibody concentration in μg/mL for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody response to the GBS-NN/NN2 vaccine at Day 197 (principal immunological endpoint). | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Day 197 |
|
|
|
| Secondary | Geometric Mean Fold Increase in Antibody Concentration for Antibodies to the Four Individual Alps | Geometric mean fold increase in antibody concentration for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) to evaluate IgG antibody responses induced by the three vaccine doses, on a 0-, 1- and 6-month regimen, in older adult participants 4 weeks after each vaccination. | Posted | Number | 95% Confidence Interval | Geometric mean fold ratio | 4 weeks after each vaccination (Days 29, 57 and 197) |
|
|
|
| Secondary | Seroconversion Rate at Any Time Post Vaccination | Seroconversion rate (proportion of participants with a 4-fold increase above baseline - pre dose concentration) at any time post vaccination to assess whether pre existing antibody levels affect the vaccine-induced antibody response. | Posted | Number | participants | Up to 6 months after last vaccination |
|
|
|
| Secondary | Proportion of Participants Achieving Antibody Concentrations for Antibodies to the Four Individual Alps | Proportion of participants achieving antibody concentrations for antibodies to the four individual Alps (Alp 1, Alp2/3, Rib and AlpC) above specific thresholds (>1, >2, >4, and >8 µg/mL) at Days 29, 57, 169, and 197, to evaluate the immune response up to 6 months following the third dose. | Posted | Number | participants | Up to day 197 |
|
|
|
| Secondary | Long-term Safety Profile of the GBS-NN/NN2 Vaccine Between Day 57 (28 Days Post Second Injection) to Day 168 and 6 Months Following the Third Dose (Safety Endpoint) |
| Posted | Number | participants | Up to day 365 |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| 17 |
| 24 |
| EG001 | Healthy Older Adult : GBS-NN/NN2 125 µg | Healthy older adult received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 0 | 24 | 1 | 24 | 16 | 24 |
| EG002 | Healthy Older Adult : Placebo | Healthy older adult received three injections of placebo. Placebo: Normal Saline 0.9 % | 0 | 12 | 2 | 12 | 10 | 12 |
| EG003 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 50 µg | Obese and/or diabetic older adults received three injections, each consisting of 50 μg of GBS-NN and 50 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 0 | 12 | 1 | 12 | 9 | 12 |
| EG004 | Obese and/or Diabetic Older Adult : GBS-NN/NN2 125 µg | Obese and/or diabetic older adults received three injections, each consisting of 125 μg of GBS-NN and 125 μg of GBS NN2 bound to aluminium hydroxide. GBS-NN/NN2: GBS-NN/NN2 bound to alhydrogel as an adjuvant | 0 | 12 | 0 | 12 | 9 | 12 |
| EG005 | Obese and/or Diabetic Older Adult : Placebo | Obese and/or diabetic older adults received three injections of placebo. Placebo: Normal Saline 0.9 % | 0 | 6 | 0 | 6 | 4 | 6 |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Injection site haemorrhage | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Injection site warmth | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Sinusitis bacterial | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Joint injury | Infections and infestations | MedDRA (26.0) | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA (26.0) | Non-systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA (26.0) | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (26.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Burnout syndrome | Psychiatric disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Hypertonic bladder | Renal and urinary disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (26.0) | Non-systematic Assessment |
|
Not provided
Not provided
| Anti-Alp2/3 |
|
| Anti-AlpC |
|
| Anti-Rib |
|
| Alp1- Day 57 |
|
| Alp1 - Day 197 |
|
| Alp2/3 - Day 29 |
|
| Alp2/3 - Day 57 |
|
| Alp2/3 - Day 197 |
|
| AlpC - Day 29 |
|
| AlpC - Day 57 |
|
| AlpC - Day 197 |
|
| Rib - Day 29 |
|
| Rib - Day 57 |
|
| Rib - Day 197 |
|
| Anti-Alp1 - Day 57 |
|
| Anti-Alp1 - Day 169 |
|
| Anti-Alp1 - Day 197 |
|
| Anti-Alp1 - Day 365 |
|
| Anti-Alp2/3 - Day 29 |
|
| Anti-Alp2/3 - Day 57 |
|
| Anti-Alp2/3 - Day 169 |
|
| Anti-Alp2/3 - Day 197 |
|
| Anti-Alp2/3 - Day 365 |
|
| Anti-AlpC - Day 29 |
|
| Anti-AlpC - Day 57 |
|
| Anti-AlpC - Day 169 |
|
| Anti-AlpC - Day 197 |
|
| Anti-AlpC - Day 365 |
|
| Anti-Rib - Day 29 |
|
| Anti-Rib - Day 57 |
|
| Anti-Rib - Day 169 |
|
| Anti-Rib - Day 197 |
|
| Anti-Rib - Day 365 |
|
| Alp 1 >1 µg/mL - Day 57 |
|
| Alp 1 >1 µg/mL - Day 169 |
|
| Alp 1 >1 µg/mL - Day 197 |
|
| Alp 1 >2 µg/mL - Day 29 |
|
| Alp 1 >2 µg/mL - Day 57 |
|
| Alp 1 >2 µg/mL - Day 169 |
|
| Alp 1 >2 µg/mL - Day 197 |
|
| Alp 1 >4 µg/mL - Day 29 |
|
| Alp 1 >4 µg/mL - Day 57 |
|
| Alp 1 >4 µg/mL - Day 169 |
|
| Alp 1 >4 µg/mL - Day 197 |
|
| Alp 1 >8 µg/mL - Day 29 |
|
| Alp 1 >8 µg/mL - Day 57 |
|
| Alp 1 >8 µg/mL - Day 169 |
|
| Alp 1 >8 µg/mL - Day 197 |
|
| Alp2/3 >1 µg/mL - Day 29 |
|
| Alp2/3 >1 µg/mL - Day 57 |
|
| Alp2/3 >1 µg/mL - Day 169 |
|
| Alp2/3 >1 µg/mL - Day 197 |
|
| Alp2/3 >2 µg/mL - Day 29 |
|
| Alp2/3 >2 µg/mL - Day 57 |
|
| Alp2/3 >2 µg/mL - Day 169 |
|
| Alp2/3 >2 µg/mL - Day 197 |
|
| Alp2/3 >4 µg/mL - Day 29 |
|
| Alp2/3 >4 µg/mL - Day 57 |
|
| Alp2/3 >4 µg/mL - Day 169 |
|
| Alp2/3 >4 µg/mL - Day 197 |
|
| Alp2/3 >8 µg/mL - Day 29 |
|
| Alp2/3 >8 µg/mL - Day 57 |
|
| Alp2/3 >8 µg/mL - Day 169 |
|
| Alp2/3 >8 µg/mL - Day 197 |
|
| Rib >1 µg/mL - Day 29 |
|
| Rib >1 µg/mL - Day 57 |
|
| Rib >1 µg/mL - Day 169 |
|
| Rib >1 µg/mL - Day 197 |
|
| Rib >2 µg/mL - Day 29 |
|
| Rib >2 µg/mL - Day 57 |
|
| Rib >2 µg/mL - Day 169 |
|
| Rib >2 µg/mL - Day 197 |
|
| Rib >4 µg/mL - Day 29 |
|
| Rib >4 µg/mL - Day 57 |
|
| Rib >4 µg/mL - Day 169 |
|
| Rib >4 µg/mL - Day 197 |
|
| Rib >8 µg/mL - Day 29 |
|
| Rib >8 µg/mL - Day 57 |
|
| Rib >8 µg/mL - Day 169 |
|
| Rib >8 µg/mL - Day 197 |
|
| AlpC >1 µg/mL - Day 29 |
|
| AlpC >1 µg/mL - Day 57 |
|
| AlpC >1 µg/mL - Day 169 |
|
| AlpC >1 µg/mL - Day 197 |
|
| AlpC >2 µg/mL - Day 29 |
|
| AlpC >2 µg/mL - Day 57 |
|
| AlpC >2 µg/mL - Day 169 |
|
| AlpC >2 µg/mL - Day 197 |
|
| AlpC >4 µg/mL - Day 29 |
|
| AlpC >4 µg/mL - Day 57 |
|
| AlpC >4 µg/mL - Day 169 |
|
| AlpC >4 µg/mL - Day 157 |
|
| AlpC >8 µg/mL - Day 29 |
|
| AlpC >8 µg/mL - Day 57 |
|
| AlpC >8 µg/mL - Day 169 |
|
| AlpC >8 µg/mL - Day 197 |
|
| SAE from Day 197 to Day 365 |
|
| MAAEs from Day 197 up to Day 365 |
|
| AESIs from Day 197 up to Day 365 |
|
| ARs/SARs from Day 197 up to Day 365 |
|