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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenC-CRM LIQ (Liquid Formulation) | Experimental | Subjects received 1 injection of MenC-CRM vaccine,liquid formulation. |
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| MenC-CRM ROS (Rosia) | Experimental | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy |
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| MenC-CRM EMV (Emeryville) | Active Comparator | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenC-CRM LIQ | Biological | One dose of MenC-CRM vaccine, liquid formulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination | Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV. | 1 month postvaccination (day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination | Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS. | 1 month postvaccination (day 29) |
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Inclusion Criteria:
Exclusion Criteria:
History of any meningococcal vaccine administration.
Previous known or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.
Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38.0°C within the previous 3 days.
Individuals who have received antibiotics within 6 days before vaccination.
Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):
History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).
Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
Taken any antipyretic medication in the previous 6 hours.
Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization).
Toddler's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study.
Family members or household members of site research staff.
History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NZOZ Bioscience Sp zoo | Ul Czerkaska | Bydgoszcz | Poland | |||
| Department Infection Disease ZOZ |
All enrolled subjects were included in the trial. Data from the group MenC-CRM ROS_EMV was not included in the primary and secondary analyses as these subjects were initially enrolled in group MenC-CRM ROS, but wrongly vaccinated with MenC-CRM EMV.
Subjects were enrolled at eleven sites in Poland.
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| ID | Title | Description |
|---|---|---|
| FG000 | MenC-CRM LIQ | Subjects received 1 injection of MenC-CRM vaccine, liquid formulation. |
| FG001 | MenC-CRM ROS | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| MenC-CRM ROS | Biological | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. |
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| MenC-CRM EMV | Biological | One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. |
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| Number Of Subjects Reporting Solicited Local And Systemic Adverse Events | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV. Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS. | From day 1 through day 7 |
| Dept Infection Disease ZOZ |
| Debica |
| Poland |
| Centrum Medyczne Graniczna Sp zoo | Ul Graniczna 45 | Katowice | Poland |
| NZOZ HIPOKRATES IIspzoo | Ul Strzelecka 2 | Krakow | Poland |
| Specjalistyczny Zespol | Ul Krysiewicza | Poznan | Poland |
| NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska | NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska | Siemianowice Slaskie | Poland |
| Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie | E Szczeklik Hospital | Tarnów | Poland |
| Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w | Ul Prusicka 5355 | Trzebnica | Poland |
| Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe | Ceglowska 80 | Warszawa | Poland |
| Amicur_Krystyna Lechka-Florianska i Partnerzy | Ul O Bujwida | Wroclaw | Poland |
| Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego | Ul. Kniaziewicza 1-5 | Łódź Voivodeship | Poland |
| FG002 | MenC-CRM EMV | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. |
| FG003 | MenC-CRM ROS_EMV | Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MenC-CRM LIQ | Subjects received 1 injection of MenC-CRM vaccine, liquid formulation. |
| BG001 | MenC-CRM ROS | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. |
| BG002 | MenC-CRM EMV | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. |
| BG003 | MenC-CRM ROS_EMV | Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV |
| BG004 | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination | Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV. | Analysis was done on the per protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month postvaccination (day 29) |
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| Secondary | Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination | Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS. | Analysis was done on the per protocol (PP) set. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 month postvaccination (day 29) |
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| Secondary | Number Of Subjects Reporting Solicited Local And Systemic Adverse Events | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV. Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS. | Analysis was done on the safety dataset, i.e. the subjects in the exposed population who provided postvaccination safety data. | Posted | Number | Number of subjects | From day 1 through day 7 |
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Solicited local and systemic adverse events from day 1 to 7. Serious adverse events (SAEs) and Unsolicited AEs (other than SAEs) from day 1 to day 29 (1 month after first vaccination).
All Solicited AEs are classified as systematic assessment and all unsolicited AEs are classified as non-systematic assessment.
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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 | MenC-CRM LIQ | Subjects received 1 injection of MenC-CRM vaccine, liquid formulation. | 0 | 299 | 252 | 299 | ||
| EG001 | MenC-CRM ROS | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. | 3 | 267 | 227 | 267 | ||
| EG002 | MenC-CRM EMV | Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. | 2 | 304 | 236 | 304 | ||
| EG003 | MenC-CRM ROS_EMV | Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV | 1 | 119 | 88 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Gastroenteritis Rotavirus | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Crying | General disorders | MedDRA | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA | Systematic Assessment |
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| Injection Site Induration | General disorders | MedDRA | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA | Systematic Assessment |
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| Irritability | General disorders | MedDRA | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Eating Disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
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| Respiratory Tract Infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
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| Male |
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| The study would be considered a success if the two-sided 95% confidence intervals (CIs) for the hSBA GMT ratios comparing MenC-CRM ROS to MenC-CRM EMV at 28 days after a single vaccination were both within the equivalence interval (0.5, 2.0). | ANOVA | 95% CIs for the GMTs ratios was obtained by exponentiating difference of least square means of log10-transformed titers and both the limits of 95% CIs | <0.05 | hSBA GMT ratios | 1.14 | 2-Sided | 95 | 0.92 | 1.41 | Non-Inferiority or Equivalence | The equivalence margin was (0.5, 2.0). If the two-sided 95% CI for the ratio of the hSBA GMTs at 28 days following vaccination was within this equivalence interval for each of the two coprimary comparisons,MenC-CRM ROS and MenC-CRM EMV would be declared equivalent with respect to the immune response to the vaccines. |
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Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV |
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