ID

33319

Descrizione

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Keywords

versioni (2)
  1. 05/12/18 05/12/18 -
  2. 05/12/18 05/12/18 -
Titolare del copyright

GSK group of companies

Caricato su

5 dicembre 2018

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0
Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Torna ai commenti del modello
Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Inglese

Visit 1: Exclusion Criteria

1 moduli  
Administrative data
Descrizione

Administrative data

Date of Visit
Descrizione

Date of Visit

Tipo di dati

date

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Eligibility check
Descrizione

Eligibility check

Did the subject meet all the entry criteria?
Descrizione

Did the subject meet all the entry criteria?

Tipo di dati

boolean

If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Descrizione

Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria listed below

Tipo di dati

text

Exclusion Criteria
Descrizione

Exclusion Criteria

For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Descrizione

tick "Yes" for any of the exclusion criteria that disqualified the subject from entry

Tipo di dati

text

Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
Descrizione

Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.

Tipo di dati

boolean

Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
Descrizione

For corticosteroids, this will mean prednisone, or equivalent >=0.5 mg/kg/day. Inhaled and topical steroids are allowed

Tipo di dati

boolean

Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Descrizione

Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.

Tipo di dati

boolean

Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
Descrizione

Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.

Tipo di dati

boolean

History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
Descrizione

History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001

Tipo di dati

boolean

Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
Descrizione

Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease

Tipo di dati

boolean

Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Descrizione

Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).

Tipo di dati

boolean

A family history of congenital or hereditary immunodeficiency.
Descrizione

A family history of congenital or hereditary immunodeficiency.

Tipo di dati

boolean

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Descrizione

History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

Tipo di dati

boolean

Major congenital defects or serious chronic illness.
Descrizione

Major congenital defects or serious chronic illness.

Tipo di dati

boolean

History of any neurologic disorders or seizures.
Descrizione

Subject who only had a single, uncomplicated febrile convulsion in the past can be included

Tipo di dati

boolean

Acute disease at the time of enrollment.
Descrizione

Acute disease - 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 t° <37.5°C/rectal t° <38°C

Tipo di dati

boolean

Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
Descrizione

Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.

Tipo di dati

boolean

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Descrizione

Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.

Tipo di dati

boolean

Specify other conditions.
Descrizione

if necessary

Tipo di dati

text

Adverse events
Descrizione

one of the following AE that constitute contraindications or precaution to further administration of DTP vaccine, having occurred after previous administration of DTP vaccine

Tipo di dati

text

Ritorna all'inizio della pagina

Similar models

Visit 1: Exclusion Criteria

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
Item Group
Eligibility check
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
Item
If No, please tick all boxes corresponding to violations of any inclusion/exclusion criteria
text
Item Group
Exclusion Criteria
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
Item
For subjects receiving Plain PRP followed by DTPw-HBV Kft:
text
Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
Item
Use of investigational or non-registered product other than study vaccine within 30 days preceding administration of the study vaccine, or planned use during the study period.
boolean
Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
Item
Chronic administration (more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
boolean
Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Item
Planned administration/administration of vaccine not foreseen by the study protocol during the 30-day period starting before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
boolean
Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
Item
Previous booster vaccination against diphteria, tetanus, pertussis, hepatitis B and/or Hib disease since the conclusion of the study DTPw=Hib Kft-001.
boolean
History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
Item
History of dyphtheria, tetanus, petrussis, hepatits B and/or Kft-001
boolean
Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
Item
Known exposure to diphtheria,tetanus, pertussis, hepatitis B and/or Hib disease
boolean
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
boolean
A family history of congenital or hereditary immunodeficiency.
Item
A family history of congenital or hereditary immunodeficiency.
boolean
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Item
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
History of any neurologic disorders or seizures.
Item
History of any neurologic disorders or seizures.
boolean
Acute disease at the time of enrollment.
Item
Acute disease at the time of enrollment.
boolean
Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
Item
Administration of immunoglobulins and/or any blood products within the three months preceding administration of the study vaccine or planned administration during the study period.
boolean
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
Item
Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
boolean
Specify other conditions.
Item
Specify other conditions.
text
Item
Adverse events
text
Adverse events
Code List
Adverse events
CL Item
Hypersensitivity to any component of the vaccine, or signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B and Hib vaccines (1)
CL Item
Encephalopathy (not due to another identifiable cause): acute, severe central nervous system disorder occurring within 7 days following vaccination->major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours (2)
CL Item
Axillary temperature of ≥ 40°C/rectal temperature ≥ 40.5°C within 48 hrs of vaccination (3)
CL Item
Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hrs of vaccination (4)
CL Item
Persistent, inconsolable crying lasting ≥3 hrs, occurring within 48 hrs of vaccination (5)
CL Item
Convulsions with or without fever, occuring within 3 days of vaccination (6)
Ritorna all'inizio della pagina 

Contatto

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Aiuto

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