ID

39545

Descrição

Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines; ODM derived from: https://clinicaltrials.gov/show/NCT01307436

Link

https://clinicaltrials.gov/show/NCT01307436

Palavras-chave

Versões (2)
  1. 26/01/2020 26/01/2020 -
  2. 26/01/2020 26/01/2020 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de janeiro de 2020

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0
Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Voltar para os comentários do modelo
Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Hepatitis A NCT01307436

Inglês

Eligibility Hepatitis A NCT01307436

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
original study:
Descrição

Clinical Trial Original

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205313
written informed consent obtained from the parent/legal guardian of the subject.
Descrição

Informed Consent Parent | Informed Consent Guardian

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0030551
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1274041
free of obvious health problems as established by medical history and/or clinical examination before entering the study.
Descrição

Free of Health problem | Medical History | Clinical Examination

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332296
UMLS CUI [1,2]
C0018684
UMLS CUI [1,3]
C0033213
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
at least 8 kg of body weight at age of 12 months.
Descrição

Body Weight | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C0001779
follow-up phase:
Descrição

Follow-up Phase

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1710475
subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines.
Descrição

Enrollment Clinical Trial Original | Randomization Clinical Trial Original | Vaccines Dose Quantity | Vaccines Investigational Hepatitis A

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0008976
UMLS CUI [1,3]
C0205313
UMLS CUI [2,1]
C0034656
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205313
UMLS CUI [3,1]
C0042210
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0042210
UMLS CUI [4,2]
C1517586
UMLS CUI [4,3]
C0019159
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
original study:
Descrição

Clinical Trial Original

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0205313
children not having received 3 documented doses of dtpahib and polio vaccines during infancy
Descrição

Children | Diphtheria-Tetanus-acellular Pertussis Vaccines Absent | Oral Polio Vaccine Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0535644
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0032375
UMLS CUI [3,2]
C0332197
children having received a documented dose of mmr during infancy
Descrição

Children | Measles-Mumps-Rubella Vaccine Dose

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0008059
UMLS CUI [2,1]
C0065828
UMLS CUI [2,2]
C0178602
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
Descrição

Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C0013231
UMLS CUI [3]
C1875384
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Descrição

Immunosuppressive Agents chronic | Biological Response Modifiers chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
administration of systemic corticosteroids (inhaled and topical steroids are allowed).
Descrição

CORTICOSTEROIDS FOR SYSTEMIC USE

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3653708
administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
Descrição

Vaccine Except Study Protocol

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332300
UMLS CUI [1,3]
C2348563
previous vaccination against hepatitis a.
Descrição

Vaccination Previous Hepatitis A

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0019159
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
Descrição

Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2,1]
C4048329
UMLS CUI [2,2]
C0750491
UMLS CUI [3]
C0021051
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0750491
UMLS CUI [5]
C0019693
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Descrição

Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4086268
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C4086268
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0042210
UMLS CUI [3,3]
C1705248
major congenital defects or serious chronic illness
Descrição

Congenital defects Major | Chronic disease Serious

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
acute disease at the time of enrolment.
Descrição

Acute Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001314
follow-up phase:
Descrição

Follow-up Phase

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1710475
children who had received a hepatitis a antigen containing vaccine since the last visit
Descrição

Vaccine Containing Hepatitis A Antigen

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332256
UMLS CUI [1,3]
C0062523
Voltar ao início da página

Similar models

Eligibility Hepatitis A NCT01307436

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Informed Consent Parent | Informed Consent Guardian
Item
written informed consent obtained from the parent/legal guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0030551 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1274041 (UMLS CUI [2,2])
Free of Health problem | Medical History | Clinical Examination
Item
free of obvious health problems as established by medical history and/or clinical examination before entering the study.
boolean
C0332296 (UMLS CUI [1,1])
C0018684 (UMLS CUI [1,2])
C0033213 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
Body Weight | Age
Item
at least 8 kg of body weight at age of 12 months.
boolean
C0005910 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Enrollment Clinical Trial Original | Randomization Clinical Trial Original | Vaccines Dose Quantity | Vaccines Investigational Hepatitis A
Item
subjects enrolled and randomised in the original study and having received two doses of the hepatitis a study vaccines.
boolean
C1516879 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0205313 (UMLS CUI [1,3])
C0034656 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205313 (UMLS CUI [2,3])
C0042210 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0042210 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
C0019159 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Clinical Trial Original
Item
original study:
boolean
C0008976 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
Children | Diphtheria-Tetanus-acellular Pertussis Vaccines Absent | Oral Polio Vaccine Absent
Item
children not having received 3 documented doses of dtpahib and polio vaccines during infancy
boolean
C0008059 (UMLS CUI [1])
C0535644 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0032375 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Children | Measles-Mumps-Rubella Vaccine Dose
Item
children having received a documented dose of mmr during infancy
boolean
C0008059 (UMLS CUI [1])
C0065828 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
Investigational New Drugs | Drugs, Non-Prescription | INVESTIGATIONAL VACCINES
Item
use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and the 30 days safety follow-up after the last dose.
boolean
C0013230 (UMLS CUI [1])
C0013231 (UMLS CUI [2])
C1875384 (UMLS CUI [3])
Immunosuppressive Agents chronic | Biological Response Modifiers chronic
Item
chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
CORTICOSTEROIDS FOR SYSTEMIC USE
Item
administration of systemic corticosteroids (inhaled and topical steroids are allowed).
boolean
C3653708 (UMLS CUI [1])
Vaccine Except Study Protocol
Item
administration of a vaccine not foreseen by the study protocol within 4 weeks prior to the first dose of study vaccine.
boolean
C0042210 (UMLS CUI [1,1])
C0332300 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Vaccination Previous Hepatitis A
Item
previous vaccination against hepatitis a.
boolean
C0042196 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0019159 (UMLS CUI [1,3])
Immunosuppression | Immunosuppression Suspected | Immunodeficiency | Immunodeficiency Suspected | HIV Infection
Item
any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (hiv) infection.
boolean
C4048329 (UMLS CUI [1])
C4048329 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0021051 (UMLS CUI [3])
C0021051 (UMLS CUI [4,1])
C0750491 (UMLS CUI [4,2])
C0019693 (UMLS CUI [5])
Hypersensitivity Exacerbation | Allergic Reaction Exacerbation | Etiology Vaccine Component
Item
history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C4086268 (UMLS CUI [1,2])
C1527304 (UMLS CUI [2,1])
C4086268 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0042210 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
Congenital defects Major | Chronic disease Serious
Item
major congenital defects or serious chronic illness
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Acute Disease
Item
acute disease at the time of enrolment.
boolean
C0001314 (UMLS CUI [1])
Follow-up Phase
Item
follow-up phase:
boolean
C3274571 (UMLS CUI [1,1])
C1710475 (UMLS CUI [1,2])
Vaccine Containing Hepatitis A Antigen
Item
children who had received a hepatitis a antigen containing vaccine since the last visit
boolean
C0042210 (UMLS CUI [1,1])
C0332256 (UMLS CUI [1,2])
C0062523 (UMLS CUI [1,3])
Voltar ao início da página 

Contacto

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Ajuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial