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To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY-CRM_6-12 M | Experimental | Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) |
|
| MenACWY-CRM_12 M | Experimental | Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) |
|
| MenC-CRM_12 M_MenACWY-CRM_18 M | Experimental | Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACWY-CRM | Biological | Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group) | Before and 1 month after 2-dose or 1-dose schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group) |
Not provided
Inclusion Criteria:
Inclusion criteria for Groups I (MenACWY-CRM_6-12 M) and II (MenACWY-CRM_12 M)
Subjects eligible for enrollment in the study were healthy infants:
Inclusion criteria for Group III (MenC-CRM_12 M_MenACWY-CRM_18 M)
Subjects eligible for enrollment in the study were healthy infants:
Exclusion criteria:
Subjects were not to be included in this study if:
their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
they previously received any meningococcal vaccine;
they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;
they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);
they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):
they had a suspected or known HIV infection or HIV-related disease;
they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;
they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
they had a history of seizure disorder:
they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic [e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin] could have been enrolled 7 days following the last dose);
their parents/legal guardians were planning to leave the area of the study center before the end of the study period;
they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Halperin, Dr. | Novartis Vaccines & Diagnostics | Principal Investigator |
| Francisco Diaz-Mitoma, Dr. | Novartis Vaccines | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Eastern Ontario Research Institute | Ottawa | Ontario | K1H 8L1 | Canada | ||
| Herridge Community Health Clinic |
All enrolled subjects were included in the study.
Subjects were enrolled at three sites in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-CRM_6-12 M | Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age). |
| FG001 | MenACWY-CRM_12 M | Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age). |
| FG002 | MenC-CRM_12 M_MenACWY-CRM_18 M | Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis was done for all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-CRM_6-12 M | Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). |
| BG001 | MenACWY-CRM_12 M |
| 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 hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group) | Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Before and 1 month after 2-dose or 1-dose schedule |
|
Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)
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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 | MenACWY-CRM_6-12M | Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
Not provided
| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| 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 |
|---|---|
| C556088 | MenACWY-CRM vaccine |
| C000625559 | MenC-CRM vaccine |
| C410218 | serogroup C meningococcal conjugate vaccine |
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| D013745 | Tetanus Toxoid |
| C512971 | pentacel |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| MenC-CRM | Biological | One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region. |
|
|
| DTaP-Hib-IPV | Biological |
|
|
| PC7 | Biological | One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh. |
|
|
| MMR | Biological |
|
|
| Varicella | Biological |
|
| Before and 1 month after 2-dose or 1-dose schedule |
| Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M) | Before and 1 month after 2-dose or 1-dose schedule |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Before and 1 month after MenC-CRM vaccination at 12 months |
| Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Before and 1 month after MenC-CRM vaccination at 12 months |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months |
| hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months |
| Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months |
| hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Before and 1 month after MenACWY-CRM vaccination at 18 months |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination | From day 1 through day 7 after any vaccination |
| Ottawa |
| Ontario |
| K1S 0G8 |
| Canada |
| Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center | Halifax | B3K 6R8 | Canada |
| Inappropriate enrollment |
|
| Unable to classify |
|
Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). |
| BG002 | MenC-CRM_12 M_MenACWY-CRM_18 M | Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months). |
| BG003 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). |
| OG001 | MenACWY-CRM_12 M | Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months). |
|
|
| Secondary | Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group) | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Before and 1 month after 2-dose or 1-dose schedule |
|
|
|
| Secondary | Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule | Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M) | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Before and 1 month after 2-dose or 1-dose schedule |
|
|
|
| Secondary | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Before and 1 month after MenC-CRM vaccination at 12 months |
|
|
|
| Secondary | Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age | The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Before and 1 month after MenC-CRM vaccination at 12 months |
|
|
|
| Secondary | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Before and 1 month after MenACWY-CRM vaccination at 18 months |
|
|
|
| Secondary | hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age | The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Before and 1 month after MenACWY-CRM vaccination at 18 months |
|
|
|
| Secondary | Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Analysis was done on PP population. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Before and 1 month after MenACWY-CRM vaccination at 18 months |
|
|
|
| Secondary | hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age | Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age | Analysis was done on PP population. | Posted | Geometric Mean | 95% Confidence Interval | Geometric mean titers | Before and 1 month after MenACWY-CRM vaccination at 18 months |
|
|
|
| Secondary | Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination | The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination | Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data. | Posted | Number | participants | From day 1 through day 7 after any vaccination |
|
|
|
| 3 |
| 64 |
| 62 |
| 64 |
| EG001 | MenACWY-CRM_12M | Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months) | 2 | 61 | 58 | 61 |
| EG002 | MenC-CRM_12M_MenACWY-CRM_18M | Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months) | 2 | 50 | 50 | 50 |
| Infectious mononucleosis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Irritability | General disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Eating disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.
| 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 |
| D000090862 | Neuroinflammatory Diseases |
| D022242 |
| Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D017778 | Vaccines, Combined |
| Serogroup C - Prevaccination |
|
| Serogroup C - Postvaccination |
|
| Serogroup W - Prevaccination (N=40,41) |
|
| Serogroup W-Postvaccination (N=40,41) |
|
| Serogroup Y - Prevaccination |
|
| Serogroup Y - Postvaccination |
|
| Serogroup C - Prevaccination |
|
| Serogroup C - Postvaccination |
|
| Serogroup W - Prevaccination (N=40,41) |
|
| Serogroup W - Postvaccination (N=40,41) |
|
| Serogroup Y - Prevaccination (N=53,54) |
|
| Serogroup Y - Postvaccination (N=53,54) |
|
|
| hSBA titers ≥1:8 - Postvaccination |
|
|
| Serogroup W - hSBA ≥1:4 - Postvaccination (N=37) |
|
| Serogroup Y - hSBA ≥1:4 - Prevaccination |
|
| Serogroup Y - hSBA ≥1:4 - Postvaccination |
|
| Serogroup A - hSBA ≥1:8 - Prevaccination |
|
| Serogroup A - hSBA ≥1:8 - Postvaccination |
|
| Serogroup W - hSBA ≥1:8 - Prevaccination (N=37) |
|
| Serogroup W - hSBA ≥1:8 - Postvaccination (N=37) |
|
| Serogroup Y - hSBA ≥1:8 - Prevaccination |
|
| Serogroup Y - hSBA ≥1:8 - Postvaccination |
|
|
| Serogroup W - Postvaccination (N=37) |
|
| Serogroup Y - Prevaccination |
|
| Serogroup Y - Postvaccination |
|
|
| hSBA ≥1:8 - Postvaccination |
|
|
| MenACWY MenC Erythema (N=64,56,50) |
|
| MenACWY MenC Induration (N=64,56,50) |
|
| DTaP-Hib-IPV Tenderness (N=64,61,44) |
|
| DTaP-Hib-IPV Erythema (N=64,61,44) |
|
| DTaP-Hib-IPV Induration (N=64,61,44) |
|
| PCV7 Tenderness |
|
| PC7 Erythema |
|
| PC7 Induration |
|
| Any systemic reactions |
|
| Change in eating habits (N=62,60,50) |
|
| Sleepiness |
|
| Irritability |
|
| Vomiting |
|
| Diarrhea |
|
| Fever (≥38 °C) |
|
| Analgesic Antipyretic Medicines Used |
|