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| ID | Type | Description | Link |
|---|---|---|---|
| CVIA-058 | Other Identifier | PATH |
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| Name | Class |
|---|---|
| PATH | OTHER |
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Out of the 13 identified serogroups of Neisseria meningitidis (Nm) the six serogroups (A, B, C, W, Y and X) are responsible for majority of infections. Presently available vaccines effectively protect against A, B, C, W and Y serogroups; but no vaccine that is protective against serogroup X is available yet.
Serum Institute of India Private Limited (SIIPL) has developed a conjugate vaccine against serogroups A, C, Y, W and X (NmCV-5).
The first-in-human Phase 1 study was among 60 healthy adults in USA did not show no any safety issues.
This phase 2 study is designed to evaluate safety and immunogenicity of the non-adjuvanted and adjuvanted formulations of NmCV-5 in healthy children 12-16 months of age, in comparison with the licensed quadrivalent meningococcal conjugate vaccine (Menactra®).
Both vaccines will be administered in two dose schedule 3 months apart. among vaccine-naïve healthy subjects in Mali. Safety will be assessed by collecting solicited reactions till day 7 post each dose whereas adverse events will be collected throughout the study. Each subject will be followed up for 84 days post each vaccine dose.
The vaccine immunogenicity will measured using a rabbit complement serum bactericidal activity assay (rSBA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adjuvanted study formulation NmCV-5 | Experimental | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. |
|
| Non-adjuvanted study formulation NmCV-5 | Experimental | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. |
|
| Menactra | Active Comparator | Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-adjuvanted study formulation NmCV-5 | Biological | Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Solicited Adverse Event | Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90) | 7 days post each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotective rSBA Titres | Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2) | 112 days |
| Long Term Protective rSBA Titres |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre pour le Développement des Vaccins du Mali, ex-Institut Marchoux, Ministry of Health, BP251 | Bamako | BP251 | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34077644 | Derived | Tapia MD, Sow SO, Naficy A, Diallo F, Haidara FC, Chaudhari A, Martellet L, Traore A, Townsend-Payne K, Borrow R, Hosken N, Smolenov I, Pisal SS, LaForce FM, Dhere RM, Kapse D, Tang Y, Alderson MR, Kulkarni PS. Meningococcal Serogroup ACWYX Conjugate Vaccine in Malian Toddlers. N Engl J Med. 2021 Jun 3;384(22):2115-2123. doi: 10.1056/NEJMoa2013615. |
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A total of 515 toddlers were consented to withhold Mali EPI MenAfriVac vaccination at 9 months and were invited to return at 12 months for a second consent and final eligibility assessment. Among these, 136 were subsequently not consented, of which 127 received MenAfriVac to align with their EPI schedule. 379 participants were subsequently consented and assessed for eligibility, of which 2 did not meet eligibility criteria and 1 withdrew consent prior to randomization, leading to 376 randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-adjuvanted Study Formulation NmCV-5 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| FG001 | Adjuvanted Study Formulation NmCV-5 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine |
| FG002 | Menactra | Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-adjuvanted Study Formulation NmCV-5 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| 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 | Severe Solicited Adverse Event | Number and Percentage of subjects with at least one severe solicited AE within 7 days after any study vaccination (Days 0-6 and Days 84-90) | Analysis population different for severe solicited AEs within 7 days after 2nd study vaccination, as number of subjects who received the 2nd dose was less than those that received the first dose. Reasons outlined in Participant Flow. | Posted | Number | 95% Confidence Interval | participants | 7 days post each vaccination |
|
Safety assessment includes occurrence of solicited local and systemic adverse reactions within 7 days of each vaccine dose; unsolicited adverse events within 28 days after each vaccine dose, AEs leading to withdrawal and SAE throughout the entire study period (168 days).
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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 | Non-adjuvanted NmCV-5 Dose 1 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. First dose to be administered is 0.5 mL intramuscularly. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Escheria Sepsis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Tenderness | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Abhijeet Dharmadhikari | Serum Institute of India Pvt. Ltd. | +91-20-26602855 | 2855 | abhijeet.dharmadhikari@seruminstitute.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2017 | Aug 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2019 | Aug 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Observer blind wherein the pharmacist and other study staff involved in vaccine administration will be aware of the treatment allocation.
The other study staff involved in safety assessments will be masked to treatment arm. The laboratory involved in immunogenicity analysis will also be blinded to the treatment allocation.
|
|
| Adjuvanted study formulation NmCV-5 | Biological | Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine |
|
|
| Menactra | Biological | Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. |
|
|
Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112 |
| 112 days |
| Rise in rSBA Titres | Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.
| 112 days |
| Geometric Mean of rSBA Titres | rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112 | 112 Days |
| Solicited Reactions | Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90); | 7 days post each vaccination |
| Adverse Events | Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111); | 112 Days |
| Other Adverse Events | AEs leading to premature withdrawal during the entire study period; | 168 Days |
| Serious Adverse Events | SAEs reported during the entire study period | 168 Days |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Subject discontinued due to travel |
|
| BG001 | Adjuvanted Study Formulation NmCV-5 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine |
| BG002 | Menactra | Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Length (cm) | Mean | Standard Deviation | centimeters |
|
| Weight (kg) | Mean | Standard Deviation | kilograms |
|
| Temperature (°C) | Mean | Standard Deviation | Celsius |
|
| Heart Rate (beats/min) | Mean | Standard Deviation | Beats/minute |
|
| Respiratory Rate (breaths per minute) | Mean | Standard Deviation | Breaths per minute |
|
| OG001 | Non-adjuvanted Study Formulation NmCV-5 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. |
| OG002 | Menactra | Subjects in this arm will licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. Dose to be administered is 0.5 mL intramuscularly in a two dose series separated by atleast 84 days. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. |
|
|
| Secondary | Seroprotective rSBA Titres | Percentage of subjects with rSBA titer ≥ 8 against serogroups A, C, W, Y and X at Visits Day 0 (Baseline), Day 28 (28 days after dose 1), Day 84 (prior to dose 2) and Day 112 (28 days after dose 2) | per protocol population | Posted | Count of Participants | Participants | 112 days |
|
|
|
| Secondary | Long Term Protective rSBA Titres | Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112 | Per Protocol Population | Posted | Count of Participants | Participants | 112 days |
|
|
|
| Secondary | Rise in rSBA Titres | Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W, Y and X at Visits Day 28 and Day 112.
| Per protocol population | Posted | Count of Participants | Participants | 112 days |
|
|
|
| Secondary | Geometric Mean of rSBA Titres | rSBA GMT for serogroups A, C, W, Y and X at Visits Day 0, Day 28, Day 84 and Day 112 | Per protocol population | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean rSBA Titer | 112 Days |
|
|
|
| Secondary | Solicited Reactions | Solicited local and systemic AEs reported during the 7 days after each vaccination (Days 0-6 and Days 84-90); | Safety Population | Posted | Count of Participants | Participants | 7 days post each vaccination |
|
|
|
| Secondary | Adverse Events | Unsolicited AEs reported during 28 days after each vaccination (Days 0-27 and Days 84-111); | Safety Population | Posted | Count of Participants | Participants | 112 Days |
|
|
|
| Secondary | Other Adverse Events | AEs leading to premature withdrawal during the entire study period; | Posted | Number | Number of events | 168 Days |
|
|
|
| Secondary | Serious Adverse Events | SAEs reported during the entire study period | Posted | Number | Number of events | 168 Days |
|
|
|
| 1 |
| 149 |
| 1 |
| 149 |
| 41 |
| 149 |
| EG001 | Adjuvanted NmCV-5 Dose 1 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. First dose to be administered is 0.5 mL intramuscularly. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine | 1 | 150 | 1 | 150 | 44 | 150 |
| EG002 | Menactra Dose 1 | Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. First dose to be administered is 0.5 mL intramuscularly. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. | 0 | 76 | 0 | 76 | 25 | 76 |
| EG003 | Non-adjuvanted NmCV-5 Dose 2 | Subjects in this arm will receive non-adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Non-adjuvanted study formulation NmCV-5 Dose 1. Non-adjuvanted study formulation NmCV-5: Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine. | 0 | 144 | 0 | 144 | 24 | 144 |
| EG004 | Adjuvanted NmCV-5 Dose 2 | Subjects in this arm will receive adjuvanted formulation of polyvalent conjugated vaccine against meningococcal serogroups A,C,Y,W & X. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after adjuvanted study formulation NmCV-5 dose 1. Adjuvanted study formulation NmCV-5: Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine | 0 | 145 | 0 | 145 | 17 | 145 |
| EG005 | Menactra Dose 2 | Subjects in this arm will receive licensed quadrivalent conjugated vaccine against meningococcal serogroups A,C,Y, & W viz. Menactra. Second dose to be administered is 0.5 mL intramuscularly at least 84 days after Menactra dose 1. Menactra: Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine. | 1 | 73 | 1 | 73 | 16 | 73 |
| Pneumonia | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Injection Site Swelling/Induration | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Decrease Eating | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Vomiting | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Fever | General disorders | MedDRA Version 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Allergic Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
|
Not provided
Not provided
| D007239 | Infections |
| D008589 | Meningococcal Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| Title | Measurements |
|---|---|
|
| Serogroup A Day 84 |
|
| Serogroup A Day 112 |
|
| Serogroup C Day 0 |
|
| Serogroup C Day 28 |
|
| Serogroup C Day 84 |
|
| Serogroup C Day 112 |
|
| Serogroup W Day 0 |
|
| Serogroup W Day 28 |
|
| Serogroup W Day 84 |
|
| Serogroup W Day 112 |
|
| Serogroup X Day 0 |
|
| Serogroup X Day 28 |
|
| Serogroup X Day 84 |
|
| Serogroup X Day 112 |
|
| Serogroup Y Day 0 |
|
| Serogroup Y Day 28 |
|
| Serogroup Y Day 84 |
|
| Serogroup Y Day 112 |
|
| Title | Measurements |
|---|---|
|
| Serogroup A Day 84 |
|
| Serogroup A Day 112 |
|
| Serogroup C Day 0 |
|
| Serogroup C Day 28 |
|
| Serogroup C Day 84 |
|
| Serogroup C Day 112 |
|
| Serogroup W Day 0 |
|
| Serogroup W Day 28 |
|
| Serogroup W Day 84 |
|
| Serogroup W Day 112 |
|
| Serogroup X Day 0 |
|
| Serogroup X Day 28 |
|
| Serogroup X Day 84 |
|
| Serogroup X Day 112 |
|
| Serogroup Y Day 0 |
|
| Serogroup Y Day 28 |
|
| Serogroup Y Day 84 |
|
| Serogroup Y Day 112 |
|
|
| Serogroup C: Day 28 |
|
| Serogroup C: Day 112 |
|
| Serogroup W: Day 28 |
|
| Serogroup W: Day 112 |
|
| Serogroup X: Day 28 |
|
| Serogroup X: Day 112 |
|
| Serogroup Y: Day 28 |
|
| Serogroup Y: Day 112 |
|
|
| Serogroup A Day 84 |
|
| Serogroup A Day 112 |
|
| Serogroup C Day 0 |
|
| Serogroup C Day 28 |
|
| Serogroup C Day 84 |
|
| Serogroup C Day 112 |
|
| Serogroup W Day 0 |
|
| Serogroup W Day 28 |
|
| Serogroup W Day 84 |
|
| Serogroup W Day 112 |
|
| Serogroup X Day 0 |
|
| Serogroup X Day 28 |
|
| Serogroup X Day 84 |
|
| Serogroup X Day 112 |
|
| Serogroup Y Day 0 |
|
| Serogroup Y Day 28 |
|
| Serogroup Y Day 84 |
|
| Serogroup Y Day 112 |
|
|
| Any Solicited Local AE |
|
|
| Tenderness |
|
|
| Swelling/Induration |
|
|
| Any Solicited Systemic AE |
|
|
| Irritability |
|
|
| Drowsiness |
|
|
| Decrease eating |
|
|
| Vomiting |
|
|
| Fever |
|
|
|
| At least one related Unsolicited AE |
|
|
| At least one serious unsolicited AE |
|
|
| At least one serious related unsolicited AE |
|
|
| Unsolicited AEs leading to withdrawal from Study |
|
|
| Unsolicited AEs leading to withdrawal from study vaccination but remaining in the study |
|
|
| unsolicited AEs leading to hospitalization |
|
|
| Unsolicited AEs leading to Death |
|
|