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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract Number: 2006-005589-38 |
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To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB | Experimental | 6-8 months-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. |
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| rMenB+OMV | Experimental | 6-8 months-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and 12 months of age. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rMenB | Biological | One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age). | Baseline and one month after second and third vaccination |
| Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Baseline and one month after second and third vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines (formerly Chiron Vaccines) Novartis | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford | OX3 7LJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35257644 | Derived | Viviani V, Biolchi A, Pizza M. Synergistic activity of antibodies in the multicomponent 4CMenB vaccine. Expert Rev Vaccines. 2022 May;21(5):645-658. doi: 10.1080/14760584.2022.2050697. Epub 2022 Mar 14. | |
| 20844462 | Derived | Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, Toneatto D, Pollard AJ. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010 Nov;29(11):e71-9. doi: 10.1097/INF.0b013e3181f59f6d. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at one study center in the United Kingdom (UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB | 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. |
| FG001 | rMenB+OMV | 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| rMenB+OMV | Biological | One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh. |
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| One month after second and third vaccination |
| Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Baseline and one month after second and third vaccination |
| Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Baseline and one month after second and third vaccination |
| Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | One month after second and third vaccination |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3). | Day 1 through day 7 after each vaccination |
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | rMenB | 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. |
| BG001 | rMenB+OMV | 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Subjects With Bactericidal Titers ≥1:4 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), evaluated using serum bactericidal assay, before vaccination (baseline) and one month after second vaccination (2 months later after vaccination at 6-8 months of age) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set, i.e. all subjects in the enrolled population who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to analysis. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Baseline and one month after second and third vaccination |
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| Primary | Percentage of Subjects With Bactericidal Titers ≥1:8 Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved bactericidal titers ≥1:8 against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Baseline and one month after second and third vaccination |
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| Secondary | Percentage of Subjects With Four-fold Rise in Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | One month after second and third vaccination |
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| Secondary | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | The immune response was measured as the geometric mean bactericidal titers directed against meningococcal strains 44/76-SL, 5/99, NZ98/254 (major strains), UK P1.7-2,4, GB101, GB355 and GB364 (additional strains), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Baseline and one month after second and third vaccination |
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| Secondary | Geometric Mean ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | The immune response was measured as the geometric mean concentrations (GMCs) against the meningococcal antigen 287-953, evaluated using enzyme-linked immunosorbent assay (ELISA), before vaccination (baseline) and one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Baseline and one month after second and third vaccination |
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| Secondary | Percentage of Subjects With Four-fold Rise in ELISA Concentration Against Meningococcal 287-953 Antigen One Month After Second and Third Vaccination of rMenB Vaccine With and Without OMV-NZ | Immunogenicity was measured as the percentage of subjects who achieved a four-fold increase in ELISA geometric mean concentrations against meningococcal 287-953 antigen, one month after second vaccination (2 months after vaccination at 6-8 months) and third vaccination (at 12 months of age). | Analysis was performed on the per protocol (PP) population set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | One month after second and third vaccination |
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| Secondary | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Each Vaccination of rMenB Vaccine With and Without OMV-NZ | Safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV-NZ administered at 6-8 months (vaccination 1), 2 months later (vaccination 2) and at 12 months (vaccination 3). | Analysis was performed on the safety set, i.e. all subjects in the exposed population who provided post-baseline safety data. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
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Throughout the study period (day 1 to follow-up of 180 days after 12 months vaccination)
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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 | rMenB | 6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. | 5 | 30 | 30 | 30 | ||
| EG001 | rMenB+OMV | 6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age. | 1 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Febrile convulsion | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Induration | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Swelling | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Crying | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| vaccination site erythema | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Eating disorder | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Teething | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Tonsilitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Varicella | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Viral rash | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
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| Injection site induration | General disorders | MedDRA (17.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Male |
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| Strain 44/76-SL - Post-3rd Vaccination (N=24,24) |
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| Strain 5/99 - Baseline |
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| Strain 5/99 - Post-2nd Vaccination (N=25,23) |
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| Strain 5/99 - Post-3rd Vaccination (N=24,24) |
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| Strain NZ98/254 - Baseline |
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| Strain NZ98/254 - Post-2nd Vaccination (N=24,22) |
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| Strain NZ98/254 - Post-3rd Vaccination (N=22,24) |
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| Strain UK P1.7-2,4 - Baseline (N=24,21) |
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| Strain UKP1.7-2,4 - Post-2nd Vaccination (N=23,19) |
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| Strain UKP1.7-2,4 - Post-3rd Vaccination (N=21,22) |
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| Strain GB101 - Baseline (N=24,21) |
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| Strain GB101 - Post-2nd Vaccination (N=22,21) |
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| Strain GB101 - Post-3rd Vaccination (N=22,22) |
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| Strain GB355 - Baseline (N=12,11) |
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| Strain GB355 - Post-2nd Vaccination (N=11,14) |
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| Strain GB355 - Post-3rd Vaccination (N=12,11) |
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| Strain GB364 - Baseline (N=22,17) |
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| Strain GB364 - Post-2nd Vaccination (N=19,16) |
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| Strain GB364 - Post-3rd Vaccination (N=17,19) |
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