ID

26671

Beschreibung

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Stichworte

Versionen (4)
  1. 23.10.17 23.10.17 -
  2. 26.10.17 26.10.17 -
  3. 26.10.17 26.10.17 -
  4. 03.11.17 03.11.17 -
Rechteinhaber

Pfizer

Hochgeladen am

23. Oktober 2017

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years

Englisch

Criteria to check at every visit

1 Formulare  
ELIMINATION CRITERIA DURING THE STUDY
Beschreibung

ELIMINATION CRITERIA DURING THE STUDY

Alias
UMLS CUI-1
C0680251
[A] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Beschreibung

Investigational new drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
[ B ] Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C1533734
UMLS CUI [2,3]
C0205191
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
Beschreibung

Meningococcal Vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700144
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Beschreibung

Other Vaccines

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
Beschreibung

Immunoglobulins | Blood products

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0371802
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Alias
UMLS CUI-1
C0522473
[ A ] Anaphylactic reaction following the administration of vaccine(s).
Beschreibung

Anaphylactic reaction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0042196
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Alias
UMLS CUI-1
C0522473
[ B ] Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Rectal temperature <38°C
Beschreibung

Acute severe illness

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4061114
UMLS CUI [1,2]
C0205082
[ C ] Axillary temperature x37.5°C / Rectal temperature x38°C.Fe
Beschreibung

Fever

Datentyp

boolean

Alias
UMLS CUI [1]
C0015967
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
Beschreibung

CONTRAINDICATIONS TO SUBSEQUENT VACCINATION

Alias
UMLS CUI-1
C0522473
[ D ] Hypersensitivity reaction due to the vaccine.
Beschreibung

Hypersensitivity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0042210
[ E ] Encephalopathy defined as an acute, severe central nervous system disorder occurring within seven days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persisted more than a few hours, with failure to recover within 24 hours.
Beschreibung

Central nervous system disorder

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007682
UMLS CUI [1,2]
C1510821
UMLS CUI [1,3]
C0042210
[ F ] Temperature x40.5°C (rectal) or x40.0°C (axillary) within 48 hours following vaccination, not due to another identifiable cause.
Beschreibung

High fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0205250
UMLS CUI [1,3]
C1510821
UMLS CUI [1,4]
C0042210
[ G ] Collapse or shock-like state (e.g., hypotonic-hyporesponsive episode) within 48 hours following vaccination.
Beschreibung

Collapse or Shock

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0344329
UMLS CUI [1,2]
C1510821
UMLS CUI [1,3]
C0042210
UMLS CUI [2,1]
C0036974
UMLS CUI [2,2]
C1510821
UMLS CUI [2,3]
C0042210
[ H ] Persistent, inconsolable crying lasting xthree hours, occurring within 48 hours following vaccination.
Beschreibung

Persistent Crying

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2721683
UMLS CUI [1,2]
C1510821
UMLS CUI [1,3]
C0042210
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Ähnliche Modelle

Criteria to check at every visit

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
ELIMINATION CRITERIA DURING THE STUDY
C0680251 (UMLS CUI-1)
Investigational new drug
Item
[A] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Concomitant Medication
Item
[ B ] Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0205191 (UMLS CUI [1,3])
C0005525 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Meningococcal Vaccine
Item
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Other Vaccines
Item
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
C0042210 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins | Blood products
Item
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0371802 (UMLS CUI [1,2])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0522473 (UMLS CUI-1)
Anaphylactic reaction
Item
[ A ] Anaphylactic reaction following the administration of vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0522473 (UMLS CUI-1)
Acute severe illness
Item
[ B ] Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature <37.5°C / Rectal temperature <38°C
boolean
C4061114 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Fever
Item
[ C ] Axillary temperature x37.5°C / Rectal temperature x38°C.Fe
boolean
C0015967 (UMLS CUI [1])
Item Group
CONTRAINDICATIONS TO SUBSEQUENT VACCINATION
C0522473 (UMLS CUI-1)
Hypersensitivity
Item
[ D ] Hypersensitivity reaction due to the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Central nervous system disorder
Item
[ E ] Encephalopathy defined as an acute, severe central nervous system disorder occurring within seven days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persisted more than a few hours, with failure to recover within 24 hours.
boolean
C0007682 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
High fever
Item
[ F ] Temperature x40.5°C (rectal) or x40.0°C (axillary) within 48 hours following vaccination, not due to another identifiable cause.
boolean
C0015967 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
C1510821 (UMLS CUI [1,3])
C0042210 (UMLS CUI [1,4])
Collapse or Shock
Item
[ G ] Collapse or shock-like state (e.g., hypotonic-hyporesponsive episode) within 48 hours following vaccination.
boolean
C0344329 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0036974 (UMLS CUI [2,1])
C1510821 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
Persistent Crying
Item
[ H ] Persistent, inconsolable crying lasting xthree hours, occurring within 48 hours following vaccination.
boolean
C2721683 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
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