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This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB | Experimental | Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without outer membrane vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of Diphtheria Tetanus Pertussis-Haemophilus influenzae type b-Inactivated Polio Vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months). |
|
| rMenB+OMV | Experimental | Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
|
| Routine | Experimental | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. |
|
| 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, BCA ≥1:4, 30 Days After the Third Immunization | Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. | Baseline and one month after third-dose of infants series |
| Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series 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 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. | Baseline and one month after third-dose of infants series |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups). | Day 1 through day 7 after each vaccination |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3). | Day 1 through day 7 after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination. |
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Inclusion Criteria:
Subjects eligible to be enrolled in the study:
healthy 2-month old infants (55-89 days, inclusive), born after full term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg;
for whom a parent/legal guardian had provided written informed consent after the nature of the study had been explained;
those available for all the visits scheduled in the study;
those in good health as determined by:
Exclusion Criteria:
Individuals were not to be enrolled into the study:
1. whose parents/legal guardians were unwilling or unable to give written informed consent to participate in the study; 2. who had previously received any meningococcal B vaccine; 3. who had received prior vaccination with Diphtheria Tetanus Pertussis (DTP) (acellular or whole cell), Inactivated Polio Vaccine (IPV) or Oral Polio Vaccine (OPV), H influenzae type b (Hib) or Heptavalent Pneumococcal Conjugate (PC7) vaccine; 4. who had a previous ascertained or suspected disease caused by N meningitidis, S pneumoniae, C diphtheriae, tetani, Poliovirus, Hib, or B pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period ≥2weeks associated with apnea or whooping); 5. who had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis, B pertussis, Hib, C diphtheriae or Polio infection since birth; 6. who had a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 7. who had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (≥38.0°C) within the previous 3 days; 8. who had any present or suspected serious acute or chronic disease (e.g., with signs of cardiac, renal failure, hepatic disease, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome); 9. who had leukemia, lymphomas; 10. who had a known or suspected autoimmune disease or impairment/alteration of immune function resulting from (for example):
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines - Information Services | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gloucester | GLI 3NN | United Kingdom | ||||
All enrolled subjects were included in the trial.
Subjects were enrolled at three study centers in the United Kingdom (UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | rMenB | Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months). |
| FG001 | rMenB+OMV | Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
| FG002 | Routine | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. |
| FG003 | Routine+OMV | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was performed on all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | rMenB | Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
| BG001 |
| 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 | Percentage of Subjects With Bactericidal Titers, BCA ≥1:4, 30 Days After the Third Immunization | Immunogenicity was measured as percentage of subjects who achieved bactericidal titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, evaluated using serum bactericidal assay, before vaccination (baseline) and at one month after third-dose of Infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. | Analysis was performed on the per protocol (PP) 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 third-dose of infants series |
|
Serious adverse events (SAEs) were collected throughout the study (day 1 through 481).
>5% Adverse Events (AEs) included the solicited local and systemic reactions collected from day 1 through day 7 after each vaccination, and non-serious unsolicited AEs collected from day 8 through day 30 after each 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 | Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MeDDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body temperature increased | Investigations | MeDDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| D013745 | Tetanus Toxoid |
| D011054 | Poliovirus Vaccine, Inactivated |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C000625559 | MenC-CRM vaccine |
| D012411 | Rubella Vaccine |
| D022542 | Measles-Mumps-Rubella Vaccine |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Routine+OMV | Experimental | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. |
|
|
| 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. |
|
|
| DTaP-Hib-IPV | Biological | Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh. |
|
|
| PC7 | Biological | IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh. |
|
|
| MenC-CRM | Biological | MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh. |
|
|
| MenC-Hib | Biological | MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh. |
|
|
| MMR | Biological | IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh. |
|
|
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3). | Day 1 through day 7 after each vaccination |
| Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3). | Day 1 through day 7 after each vaccination |
| Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only). | Day 1 through day 7 after each vaccination |
| Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers. | 30 days after the third vaccination |
| Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection. | At baseline (pre-vaccination) and 30 days after the third vaccination |
| 1 month after first vaccination |
| Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination. | prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination |
| Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population. | pre-first vaccination and 1 month after first vaccination |
| Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age. | 30 days after the second vaccination and 1 month after fourth (booster) vaccination |
| Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. | pre-first vaccination and 1 month after first vaccination |
| Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age. | 1 month after first vaccination |
| Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age. | At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination. |
| Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population. | At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age. |
| London |
| NW9 5EQ |
| United Kingdom |
| Oxford | OX3 7LJ | United Kingdom |
| Lost to Follow-up |
|
| Protocol Violation |
|
| rMenB+OMV |
Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
| BG002 | Routine | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. |
| BG003 | Routine+OMV | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. |
| BG004 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | rMenB+OMV | Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). |
|
|
| Secondary | Percentages of Subjects With Fourfold Rises in Bactericidal Titers 1 Month After First Vaccination | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with fourfold rises in bactericidal titers for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) 1 month after first vaccination. The analysis was done on the Per Protocol population 1 month after first vaccination. | Analysis was performed on the PP set. | Posted | Number | 95% Confidence Interval | Percentage of subjects | 1 month after first vaccination |
|
|
|
| Primary | Geometric Mean Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series 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 and NZ98/254, before vaccination (baseline) and at one month after third-dose of infants series vaccination of rMenB vaccine with and without OMV administered at 6 months of age. | Analysis was performed on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | titers | Baseline and one month after third-dose of infants series |
|
|
|
| Secondary | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to the First Dose, 30 Days After the Second Immunization and at 12 Months Age | Geometric mean bactericidal titers as measure of the Bactericidal activity against meningococcal strains 44/76-SL, 5/99 and NZ98/254, before vaccination (baseline) and at 30 days after second immunization, at 12 months age,and 30 days after the fourth (booster) vaccination. | Analysis was performed on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | titers | prior 1st dose, 30 days post-2nd vaccination, 12 months age to 1 month post 4th vaccination |
|
|
|
| Secondary | Geometric Mean Titers Against a Panel of Genetically Distinct Meningococcal Strains Prior to and 30 Days After a Single Dose Administered at 12 Months of ageVaccination of rMenB Vaccine With and Without OMV-NZ | Geometric Mean Titers (GMTs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Routine +Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) at 12 months age, i.e. pre-first vaccination and 1 month after first vaccination. The analysis was done on the Per Protocol population. | Analysis was performed on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | titers | pre-first vaccination and 1 month after first vaccination |
|
|
|
| Secondary | Geometric Mean Ratios (GMRs) to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Second Immunization and 1 Month After Fourth (Booster) Vaccination | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the second immunization and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population at 30 days after the second immunization and 1 month after fourth (booster) vaccination.of age. | Analysis was performed on the PP set. | Posted | Geometric Mean | 95% Confidence Interval | ratios | 30 days after the second vaccination and 1 month after fourth (booster) vaccination |
|
|
|
| Secondary | Percentages of Subjects With Bactericidal Titers ≥1:4 at 12 Months Age | Percentages of subjects treated with Routine + Novartis rMenB Vaccine +/- OMV NZ (Groups III and IV) with a bactericidal activity (BCA) measured as BCA titer ≥1:4 for the for three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. The analysis was done on the Per Protocol population at 12 months age, i.e. pre-first vaccination, and 1 month after first vaccination. | Analysis was performed on the PP set after booster vaccination. | Posted | Number | 95% Confidence Interval | Percentage of subjects | pre-first vaccination and 1 month after first vaccination |
|
|
|
| Primary | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of rMenB Vaccine With and Without OMV | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of rMenB vaccine with and without OMV administered at 2 months (vaccination 1), 4 months (vaccination 2), 6 months (vaccination 3) and 12 months (vaccination 4; vaccination 1 for Routine and Routine+OMV groups). | Analysis was performed on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
|
|
|
| Primary | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of PC7 | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of PC7 administered at 2 months (vaccination 1) and 4 months (vaccination 3). | Analysis was performed on the safety set. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
|
|
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| Primary | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of DTaP-Hib-IPV Pentavalent Vaccine | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of the pentavalent vaccine DTaP-Hib-IPV administered at 2 months (vaccination 1), 3 months (vaccination 2) and 4 months (vaccination 3). | Analysis was performed on the safety set. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
|
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|
| Primary | Number of Subjects Who Reported Solicited Local Reactions After Each Vaccination of MenC-CRM or MenC-Hib | Safety was assessed as the number of subjects who reported solicited local reactions from day 1 through day 7 after each vaccination of MenC-CRM administered at 2 months (vaccination 1) and 5 months (vaccination 2). MenC-Hib was administered at 12 months of age (vaccination 3). | Analysis was performed on the safety set. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
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| Primary | Number of Subjects Who Reported Solicited Systemic Reactions And Other Indicator of Reactogenicity After Each Vaccination Administered During Study | Safety was assessed as the number of subjects who reported solicited systemic reactions and other indicator of reactogenicity from day 1 through day 7 after each vaccination administered during study as follow: rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 2 months (vaccination 1), MenC-CRM, DTaP-Hib-IPV at 3 months (vaccination 2), rMenB vaccine with and without OMV, PC7, DTaP-Hib-IPV at 4 months (vaccination 3), MenC-CRM at 5 months (vaccination 4), rMenB vaccine with and without OMV at 6 months (vaccination 5; rMenB and rMenB+OMV groups only), rMenB vaccine with and without OMV at 12 months (vaccination 5; routine and routine+OMV groups only), and rMenB vaccine with and without OMV (vaccination 6; rMenB and rMenB+OMV groups only). | Analysis was performed on the safety set. | Posted | Number | Number of subjects | Day 1 through day 7 after each vaccination |
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| Primary | Percentage of Subjects With Fourfold Rises in Bactericidal Titers Against Meningococcal Strains One Month After Third-Dose of Infants Series Vaccination or rMenB Vaccine With and Without OMV-NZ. | Percentage of subjects fourfold increase in bactericidal titers against meningococcal strains 44/76-SL, 5/99 and NZ98/254 were measured at one month after third-dose and calculated respect to baseline titers. | Analysis was performed on the Per Protocol Set (PP) 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 | 30 days after the third vaccination |
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| Primary | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After the Third Immunization. | Geometric Mean Ratios (GMRs) as measure of the bactericidal activity against the for the three major meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) in subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) at 30 days after the third immunization. The analysis was done on the Per Protocol population at one month after third injection. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | At baseline (pre-vaccination) and 30 days after the third vaccination |
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| Secondary | Geometric Mean Ratios to Baseline Against a Panel of Genetically Distinct Meningococcal Strains 30 Days After a Single Dose Administered at 12 Months of Age | Geometric Mean Ratios to baseline against a panel of genetically distinct meningococcal strains 30 days after a single dose administered at 12 months of age. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | 1 month after first vaccination |
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| Secondary | Percentages of Subjects With Fourfold Rises in Bactericidal Titers After the Second Immunization and at 12 Months Age | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with fourfold rises in bactericidal titers for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, i.e. 6 months after third (pre-booster) vaccination, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population 30 days after the second vaccination and at 12 months age. | Posted | Number | 95% Confidence Interval | Percentages of Subjects | At pre-vaccination and 30 days post the 2nd vaccination and at 12 months age, and 1 month post 4th (booster) vaccination. |
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| Secondary | Percentages of Subjects With Bactericidal Titers, BCA, ≥1:4 After the Second Immunization and at 12 Months Age | Percentages of subjects treated with Novartis rMenB Vaccine +/- OMV NZ (Groups I and II) with a BCA titer ≥1:4 for the three meningococcal B strains (Strain 44/76-SL, Strain 5/99, Strain NZ98/254) at 30 days after the second vaccination and at 12 months age, and 1 month after fourth (booster) vaccination. The analysis was done on the Per Protocol population. | Posted | Number | 95% Confidence Interval | Percentages of Subjects | At baseline (pre-vaccination) and 30 days after the second vaccination and at 12 months age. |
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| 3 |
| 48 |
| 48 |
| 48 |
| EG001 | rMenB+OMV | Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). | 9 | 50 | 50 | 50 |
| EG002 | Routine | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age. | 4 | 25 | 25 | 25 |
| EG003 | Routine+OMV | Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age. | 2 | 24 | 24 | 24 |
| Deafness | Ear and labyrinth disorders | MeDDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MeDDRA | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Arthritis reactive | Musculoskeletal and connective tissue disorders | MeDDRA | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MeDDRA | Non-systematic Assessment |
|
| Purpura | Skin and subcutaneous tissue disorders | MeDDRA | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MeDDRA | Non-systematic Assessment |
|
| wheezing | Respiratory, thoracic and mediastinal disorders | MeDDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MeDDRA | Non-systematic Assessment |
|
| Crying | General disorders | MeDDRA | Non-systematic Assessment |
|
| Injection Site Bruising | General disorders | MeDDRA | Non-systematic Assessment |
|
| Injection Site Erythema | General disorders | MeDDRA | Non-systematic Assessment |
|
| Injection site induration | General disorders | MeDDRA | Non-systematic Assessment |
|
| Injection Site pain | General disorders | MeDDRA | Non-systematic Assessment |
|
| Pyrexia | General disorders | MeDDRA | Non-systematic Assessment |
|
| Vaccination Site Erythema | General disorders | MeDDRA | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MeDDRA | Non-systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MeDDRA | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MeDDRA | Non-systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MeDDRA | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MeDDRA | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MeDDRA | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MeDDRA | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MeDDRA | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Lower Respiratory Tract Infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Viral Infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
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| Viral Rash | Infections and infestations | MeDDRA | Non-systematic Assessment |
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| Viral Upper Respiratory Tract Infection | Infections and infestations | MeDDRA | Non-systematic Assessment |
|
| Vaccination Site Induration | General disorders | MeDDRA | Non-systematic Assessment |
|
Not provided
| D007239 | Infections |
| D015164 |
| Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D017778 | Vaccines, Combined |
| D008458 | Measles Vaccine |
| D009108 | Mumps Vaccine |
| NZ98/254 (1 month after first Vacc; N=21, 22) |
|
| 44/76-SL (1 month after 4th (booster); N=37, 30) |
|
| 5/99 (1 month after 4th (booster); N=33, 27) |
|
| NZ98/254 (1 month after 4th (booster); N=38, 29) |
|
| Strain 5/99 - Baseline (N=42,43) |
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| Strain 5/99 - Post-3rd dose (N=32,37) |
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| Strain NZ98/254 - Baseline (N=46,46) |
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| Strain NZ98/254 - Post-3rd dose (N=37,40) |
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| Strain NZ98/254 (pre-vaccination; N=46, 46) |
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| Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) |
|
| Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) |
|
| Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) |
|
| 44/76-SL (6 months after pre-booster; N=40, 44) |
|
| 5/99 (6 months after pre-booster; N=37, 40) |
|
| NZ98/254 (6 months after pre-booster; N=41, 44) |
|
| 44/76-SL (1 month after booster; N=38, 31) |
|
| 5/99 (1 month after booster; N=34, 30) |
|
| NZ98/254 (1 month after booster; N=39, 31) |
|
| NZ98/254 (pre-vaccination; N=21, 22) |
|
| 44/76-SL (1 month after first Vacc; N=22,22) |
|
| 5/99 (1 month after first Vacc; N=21,22) |
|
| NZ98/254 (1 month after first Vacc; N=21, 22) |
|
| Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38) |
|
| 44/76-SL (1 month after booster; N=38, 31) |
|
| 5/99 (1 month after booster; N=34, 30) |
|
| NZ98/254 (1 month after booster; N=39, 31) |
|
| NZ98/254 (12 Months Age, pre-first vacc; N=21,22) |
|
| 44/76-SL (1 month after first Vacc; N=22,22) |
|
| 5/99 (1 month after first Vacc; N=21,22) |
|
| NZ98/254 (1 month after first Vacc; N=21, 22) |
|
| Tenderness - Vaccination 2 (N=48,48,24,23) |
|
| Tenderness - Vaccination 3 (N=47,48,24,23) |
|
| Tenderness - Vaccination 4 (N=45,48,24,23) |
|
| Erythema - Vaccination 1 |
|
| Erythema - Vaccination 2 (N=48,48,24,23) |
|
| Erythema - Vaccination 3 (N=47,48,24,23) |
|
| Erythema - Vaccination 4 (N=45,48,24,23) |
|
| Induration - Vaccination 1 |
|
| Induration - Vaccination 2 (N=48,48,24,23) |
|
| Induration - Vaccination 3 (N=47,48,24,23) |
|
| Induration - Vaccination 4 (N=45,48,24,23) |
|
| Tenderness - Vaccination 3 (N=48,48,25,24) |
|
| Erythema - Vaccination 1 |
|
| Erythema - Vaccination 3 (N=48,48,25,24) |
|
| Induration - Vaccination 1 |
|
| Induration - Vaccination 3 (N=48,48,25,24) |
|
| Tenderness - Vaccination 2 (N=48,49,25,24) |
|
| Tenderness - Vaccination 3 (N=48,48,25,24) |
|
| Erythema - Vaccination 1 |
|
| Erythema - Vaccination 2 (N=48,49,25,24) |
|
| Erythema - Vaccination 3 (N=48,48,25,24) |
|
| Induration - Vaccination 1 |
|
| Induration - Vaccination 2 (N=48,49,25,24) |
|
| Induration - Vaccination 3 (N=48,48,25,24) |
|
| Tenderness - Vaccination 2 (N=48,48,25,24) |
|
| Tenderness - Vaccination 3 (N=45,48,24,23) |
|
| Erythema - Vaccination 1 |
|
| Erythema - Vaccination 2 (N=48,48,25,24) |
|
| Erythema - Vaccination 3 (N=45,48,24,23) |
|
| Induration - Vaccination 1 |
|
| Induration - Vaccination 2 (N=48,48,25,24) |
|
| Induration - Vaccination 3 (N=45,48,24,23) |
|
| Change in eating habits- Vaccin 2 (N=48,49,25,24) |
|
| Change in eating habits- Vaccin 3 (N=48,48,25,24) |
|
| Change in eating habits- Vaccin 4 (N=48,48,25,24) |
|
| Change in eating habits- Vaccin 5 (N=47,48,24,23) |
|
| Change in eating habits- Vaccin 6 (N=45,48,25,24) |
|
| Sleepiness - Vaccination 1 |
|
| Sleepiness - Vaccination 2 (N=48,49,25,24) |
|
| Sleepiness - Vaccination 3 (N=48,48,25,24) |
|
| Sleepiness - Vaccination 4 (N=48,48,25,24) |
|
| Sleepiness - Vaccination 5 (N=47,48,24,23) |
|
| Sleepiness - Vaccination 6 (N=45,48,25,24) |
|
| Vomiting - Vaccination 1 |
|
| Vomiting - Vaccination 2 (N=48,49,25,24) |
|
| Vomiting - Vaccination 3 (N=48,48,25,24) |
|
| Vomiting - Vaccination 4 (N=48,48,25,24) |
|
| Vomiting - Vaccination 5 (N=47,48,24,23) |
|
| Vomiting - Vaccination 6 (N=45,48,25,24) |
|
| Diarrhea - Vaccination 1 |
|
| Diarrhea - Vaccination 2 (N=48,49,25,24) |
|
| Diarrhea - Vaccination 3 (N=48,48,25,24) |
|
| Diarrhea - Vaccination 4 (N=48,48,25,24) |
|
| Diarrhea - Vaccination 5 (N=47,48,24,23) |
|
| Diarrhea - Vaccination 6 (N=45,48,25,24) |
|
| Irritability - Vaccination 1 |
|
| Irritability - Vaccination 2 (N=48,49,25,24) |
|
| Irritability - Vaccination 3 (N=48,48,25,24) |
|
| Irritability - Vaccination 4 (N=48,48,25,24) |
|
| Irritability - Vaccination 5 (N=47,48,24,23) |
|
| Irritability - Vaccination 6 (N=45,48,25,24) |
|
| Unusual crying - Vaccination 1 |
|
| Unusual crying - Vaccination 2 (N=48,49,25,24) |
|
| Unusual crying - Vaccination 3 (N=48,48,25,24) |
|
| Unusual crying - Vaccination 4 (N=48,48,25,24) |
|
| Unusual crying - Vaccination 5 (N=47,48,24,23) |
|
| Unusual crying - Vaccination 6 (N=45,48,25,24) |
|
| Rash - Vaccination 1 (N=48,50,25,24) |
|
| Rash - Vaccination 2 (N=48,49,25,24) |
|
| Rash - Vaccination 3 (N=48,48,25,24) |
|
| Rash - Vaccination 4 (N=48,48,25,24) |
|
| Rash - Vaccination 5 (N=47,48,24,23) |
|
| Rash - Vaccination 6 (N=45,48,25,24) |
|
| Fever (≥38 °C) - Vaccination 1 (N=48,50,25,23) |
|
| Fever (≥38 °C) - Vaccination 2 (N=48,49,25,24) |
|
| Fever (≥38 °C) - Vaccination 3 (N=48,48,25,24) |
|
| Fever (≥38 °C) - Vaccination 4 (N=48,48,25,24) |
|
| Fever (≥38 °C) - Vaccination 5 (N=47,48,24,23) |
|
| Fever (≥38 °C) - Vaccination 6 (N=45,48,25,24) |
|
| Analgesic/Antipyretic Med. Used-Vaccination 1 |
|
| Analg. Antipyr. Med. Used-Vaccin 2 (N=48,49,25,24) |
|
| Analg. Antipyr. Med. Used-Vaccin 3 (N=48,48,25,24) |
|
| Analg. Antipyr. Med. Used-Vaccin 4 (N=48,48,25,24) |
|
| Analg. Antipyr. Med. Used-Vaccin 5 (N=47,48,24,23) |
|
| Analg. Antipyr. Med. Used-Vaccin 6 (N=45,48,25,24) |
|
| Str. NZ98/254-4-fold Rise-Post-3rd dose (N=37,40) |
|
| Strain NZ98/254 (1 Month After 3rd |
|
| NZ98/254 (1 month after first Vacc; N=21, 22) |
|
| Strain NZ98/254 (1 Month After 2nd Vacc N=41, 38) |
|
| 44/76-SL (6 months after pre-booster; N=40, 44) |
|
| 5/99 (6 months after pre-booster; N=37, 40) |
|
| NZ98/254 (6 months after pre-booster; N=41, 44) |
|
| 44/76-SL (1 month after 4th (booster); N=37, 30) |
|
| 5/99 (1 month after 4th (booster); N=33, 27) |
|
| NZ98/254 (1 month after 4th (booster); N=38, 29) |
|
| Strain NZ98/254 Pre-Vaccination; N=46, 46) |
|
| Strain 44/76-SL (1 Month After 2nd Vacc; N=40, 37) |
|
| Strain 5/99 (1 Month After 2nd Vacc; N=36, 33) |
|
| Strain NZ98/254 (1 Month After 2nd Vacc; N=41, 38 |
|
| 44/76-SL (6 months after pre-booster; N=40, 44) |
|
| Strain 5/99 (6 months after prebooster; N=37, 40) |
|
| NZ98/254 (6 months after pre-booster; N=41, 44) |
|
| 44/76-SL (1 month after booster; N=38, 31) |
|
| 5/99 (1 month after booster; N=34, 30) |
|
| NZ98/254 (1 month after booster; N=39, 31) |
|