ID

35895

Descripción

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Palabras clave

Versiones (1)
  1. 2/4/19 2/4/19 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

2 de abril de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

Inglés

Extended Safety Follow-Up

1 formularios  
Extended Safety Follow-Up
Descripción

Extended Safety Follow-Up

Alias
UMLS CUI-1
C1522577
Since the last contact, has your child: • experienced any illness or event that: − put your child's life in danger? − was disabling/incapacitating? − resulted in a hospital admission? − prolonged a hospital stay due to a worsening of an event for which your child was admitted or because of a complication of this event? • experienced any other medically important event? • been diagnosed with a cancer?
Descripción

No to all, skip to question 10. Yes to any, continue to next question (2).

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0006826
Has this event been reported to the study staff?
Descripción

Yes , go to question 10. Following the phone call, the record of the illness/event must be verified. If there is no record of this reported illness/event, contact the parent and obtain the information. !No , complete questions 3 through 9. Determine if more than one serious adverse event (SAE) occurred and complete information for each SAE.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0684224
What was this illness/event? Please briefly describe the illness/event. Was a diagnosis given? [If so,] What was the diagnosis?
Descripción

Serious Adverse Event, Description, Diagnosis

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0678257
UMLS CUI [1,3]
C0011900
When did the illness/event begin (day, month, year)?
Descripción

Serious Adverse Event, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0808070
When did the illness/event end (day, month, year)?
Descripción

Serious Adverse Event, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0806020
Was your child hospitalized for the illness/event? [If no,] Was your child seen at an emergency room for illness/event? [If no,] Was your child seen by medical personnel, that is an M.D., D.O., or nurse practitioner in an office setting for the illness/event?
Descripción

No to all 3 questions, record no and go to next question 7. Yes, record yes and which type of medical advice and go to next question 7.

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1708385
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C0583237
UMLS CUI [3,1]
C1519255
UMLS CUI [3,2]
C1512346
Which of the following best describes the outcome of your child's illness/event:
Descripción

Adverse Event Outcome

Tipo de datos

text

Alias
UMLS CUI [1]
C1705586
Were any medications given to treat this illness/event? [If yes,] − What was the name of the medicine given? − What was the dosage (amount of medicine)? − How often was the medicine given? − How was the medicine given [for example, by mouth, by shot (injection) or by intravenous administration]? − What date was your child started on this medication? − What date did your child stop receiving this medication? − What was the reason for the medication?
Descripción

Serious Adverse Event, Pharmaceutical Preparations

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0013227
You have answered many questions describing this illness/event. Is there anything else that you can tell me about this event?
Descripción

Serious Adverse Event, Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1522508
Has your child experienced any new illness that is chronic (ongoing) such as: • Diabetes, • Autoimmune disorders, • Asthma and/or, • Allergies
Descripción

Chronic Disease, New onset

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0746890
Briefly describe the illness/event (diagnosis if you have one) that your child had.
Descripción

Chronic Disease, Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0678257
On what date did this illness/event start?
Descripción

Chronic Disease, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0808070
How severe was the illness/event?
Descripción

Chronic Disease, Severity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0439793
Was your child hospitalized for the illness/event? [If no,]Was your child seen at an emergency room for the illness/event? [If no,] Was your child seen by a medical personnel, that is a M.D., D.O., or nurse practitioner in an office setting for the illness/event?
Descripción

Chronic disease, Hospitalization; Chronic Disease; Emergency room admission; Chronic disease, Patient visit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0583237
UMLS CUI [3,1]
C0008679
UMLS CUI [3,2]
C1512346
Has your child experienced any of these specific types of rash? [If the rash was any of the following, please describe using the specific terminology underlined below.] • Hives (welts), • Idiopathic thrombocytopenic purpura (small blood blisters or large number of bruises) and/or, • Petechiae (blood blisters or red dots that don't disappear when you press near them). [Do not report rashes other than the ones specified above.)
Descripción

Exanthema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0015230
Briefly describe the rash that your child had.
Descripción

Exanthema, Description

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0678257
On what date did this rash start?
Descripción

Exanthema, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0808070
On what date did the rash stop?
Descripción

Exanthema, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0806020
How severe was the rash?
Descripción

Exanthema, Severity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0439793
Which of the following best describes the outcome of your child's rash:
Descripción

Exanthema, Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C1547647
Was your child hospitalized for the rash? [If no,] Was your child seen at an emergency room for the rash? [If no,] Was your child seen by medical personnel, that is an M.D., D.O., or nurse practitioner in an office setting for the rash?
Descripción

Exanthema, Hospitalization; Exanthema, Emergency room admission; Exanthema, Patient visit

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C0015230
UMLS CUI [2,2]
C0583237
UMLS CUI [3,1]
C0015230
UMLS CUI [3,2]
C1512346
Since the last visit, did your child require an emergency room (ER) visit? [If yes,] I would like to ask you more about the illness/event that required an emergency room visit.
Descripción

Emergency room admission

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0583237
Briefly describe this illness/event (diagnosis if you have one) that your child had.
Descripción

Emergency room admission, Disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0012634
On what date did this illness/event start?
Descripción

Emergency room admission, Disease, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
On what date did this illness/event stop?
Descripción

Emergency room admission, Disease, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
How severe was this illness/event?
Descripción

Emergency room admission, Disease, Severity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0439793
Which of the following best describes the outcome of your child's illness/event:
Descripción

Emergency room admission, Disease, Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0583237
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1547647
Did your child require a physician office visit(s) that was not related to well-child care, vaccination, injury, or common illnesses such as upper respiratory infection, otitis media (middle ear inflammation), pharyngitis (sore throat), and gastroenteritis (stomach/intestinal illness)? [If yes,] I would like to ask you more about this illness/event that required a physician office visit.
Descripción

Office visit

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0028900
Briefly describe this illness/event (diagnosis if you have one) that your child had.
Descripción

Office visit, Disease

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0012634
On what date did this illness/event start?
Descripción

Office visit, Disease, Start Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0808070
On what date did this illness/event stop?
Descripción

Office visit, Disease, End Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0806020
How severe was this illness/event?
Descripción

Office visit, Disease, Severity

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0439793
Which of the following best describes the outcome of your child's event/symptom:
Descripción

Office visit, Disease, Outcome

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0028900
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C1547647
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Similar models

Extended Safety Follow-Up

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Extended Safety Follow-Up
C1522577 (UMLS CUI-1)
Disease; Malignant Neoplasms
Item
Since the last contact, has your child: • experienced any illness or event that: − put your child's life in danger? − was disabling/incapacitating? − resulted in a hospital admission? − prolonged a hospital stay due to a worsening of an event for which your child was admitted or because of a complication of this event? • experienced any other medically important event? • been diagnosed with a cancer?
boolean
C0012634 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
Serious Adverse Event, Report
Item
Has this event been reported to the study staff?
boolean
C1519255 (UMLS CUI [1,1])
C0684224 (UMLS CUI [1,2])
Serious Adverse Event, Description, Diagnosis
Item
What was this illness/event? Please briefly describe the illness/event. Was a diagnosis given? [If so,] What was the diagnosis?
text
C1519255 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,3])
Serious Adverse Event, Start Date
Item
When did the illness/event begin (day, month, year)?
date
C1519255 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Serious Adverse Event, End Date
Item
When did the illness/event end (day, month, year)?
date
C1519255 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Serious Adverse Event, Hospitalization; Serious Adverse Event, Emergency Room Admission; Serious Adverse Event, Patient visit
Item
Was your child hospitalized for the illness/event? [If no,] Was your child seen at an emergency room for illness/event? [If no,] Was your child seen by medical personnel, that is an M.D., D.O., or nurse practitioner in an office setting for the illness/event?
boolean
C1519255 (UMLS CUI [1,1])
C1708385 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0583237 (UMLS CUI [2,2])
C1519255 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
Item
Which of the following best describes the outcome of your child's illness/event:
text
C1705586 (UMLS CUI [1])
Adverse Event Outcome
Code List
Which of the following best describes the outcome of your child's illness/event:
CL Item
your child recovered or is now fine, (1)
CL Item
your child's recovering but the illness/event is still present, (2)
CL Item
the illness/event is still present, (3)
CL Item
your child recovered from the acute (short-term) illness/event, but still has some symptom or condition as result of this event (4)
Serious Adverse Event, Pharmaceutical Preparations
Item
Were any medications given to treat this illness/event? [If yes,] − What was the name of the medicine given? − What was the dosage (amount of medicine)? − How often was the medicine given? − How was the medicine given [for example, by mouth, by shot (injection) or by intravenous administration]? − What date was your child started on this medication? − What date did your child stop receiving this medication? − What was the reason for the medication?
text
C1519255 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Serious Adverse Event, Details
Item
You have answered many questions describing this illness/event. Is there anything else that you can tell me about this event?
text
C1519255 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
Chronic Disease, New onset
Item
Has your child experienced any new illness that is chronic (ongoing) such as: • Diabetes, • Autoimmune disorders, • Asthma and/or, • Allergies
boolean
C0008679 (UMLS CUI [1,1])
C0746890 (UMLS CUI [1,2])
Chronic Disease, Description
Item
Briefly describe the illness/event (diagnosis if you have one) that your child had.
text
C0008679 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Chronic Disease, Start Date
Item
On what date did this illness/event start?
date
C0008679 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Item
How severe was the illness/event?
text
C0008679 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Chronic Disease, Severity
Code List
How severe was the illness/event?
CL Item
Was easily tolerated by your child, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Was sufficiently discomforting to interfere with your child's normal everyday activities. (2)
CL Item
Prevented normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at a day-care center and would cause the parents/ guardians to seek medical advice.) (3)
Chronic disease, Hospitalization; Chronic Disease; Emergency room admission; Chronic disease, Patient visit
Item
Was your child hospitalized for the illness/event? [If no,]Was your child seen at an emergency room for the illness/event? [If no,] Was your child seen by a medical personnel, that is a M.D., D.O., or nurse practitioner in an office setting for the illness/event?
text
C0008679 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0583237 (UMLS CUI [2,2])
C0008679 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
Exanthema
Item
Has your child experienced any of these specific types of rash? [If the rash was any of the following, please describe using the specific terminology underlined below.] • Hives (welts), • Idiopathic thrombocytopenic purpura (small blood blisters or large number of bruises) and/or, • Petechiae (blood blisters or red dots that don't disappear when you press near them). [Do not report rashes other than the ones specified above.)
boolean
C0015230 (UMLS CUI [1])
Exanthema, Description
Item
Briefly describe the rash that your child had.
text
C0015230 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
Exanthema, Start Date
Item
On what date did this rash start?
date
C0015230 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Exanthema, End Date
Item
On what date did the rash stop?
date
C0015230 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
How severe was the rash?
text
C0015230 (UMLS CUI [1,1])
C0439793 (UMLS CUI [1,2])
Exanthema, Severity
Code List
How severe was the rash?
CL Item
Was easily tolerated by your child, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Was sufficiently discomforting to interfere with your child's normal everyday activities. (2)
CL Item
Prevented normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at a day-care center and would cause the parents/ guardians to seek medical advice.) (3)
Item
Which of the following best describes the outcome of your child's rash:
text
C0015230 (UMLS CUI [1,1])
C1547647 (UMLS CUI [1,2])
Exanthema, Outcome
Code List
Which of the following best describes the outcome of your child's rash:
CL Item
your child recovered or is now fine, (1)
CL Item
your child's recovering but the rash is still present, (2)
CL Item
the rash is still present, (3)
CL Item
your child recovered from the rash, but still has some symptom or condition as result of this event. (4)
Exanthema, Hospitalization; Exanthema, Emergency room admission; Exanthema, Patient visit
Item
Was your child hospitalized for the rash? [If no,] Was your child seen at an emergency room for the rash? [If no,] Was your child seen by medical personnel, that is an M.D., D.O., or nurse practitioner in an office setting for the rash?
text
C0015230 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C0015230 (UMLS CUI [2,1])
C0583237 (UMLS CUI [2,2])
C0015230 (UMLS CUI [3,1])
C1512346 (UMLS CUI [3,2])
Emergency room admission
Item
Since the last visit, did your child require an emergency room (ER) visit? [If yes,] I would like to ask you more about the illness/event that required an emergency room visit.
boolean
C0583237 (UMLS CUI [1])
Emergency room admission, Disease
Item
Briefly describe this illness/event (diagnosis if you have one) that your child had.
text
C0583237 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Emergency room admission, Disease, Start Date
Item
On what date did this illness/event start?
date
C0583237 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Emergency room admission, Disease, End Date
Item
On what date did this illness/event stop?
date
C0583237 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
How severe was this illness/event?
text
C0583237 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,3])
Emergency room admission, Disease, Severity
Code List
How severe was this illness/event?
CL Item
Was easily tolerated by your child, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Was sufficiently discomforting to interfere with your child's normal everyday activities. (2)
CL Item
Prevented normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at a day-care center and would cause the parents/ guardians to seek medical advice.) (3)
Item
Which of the following best describes the outcome of your child's illness/event:
text
C0583237 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1547647 (UMLS CUI [1,3])
Emergency room admission, Disease, Severity
Code List
Which of the following best describes the outcome of your child's illness/event:
CL Item
your child recovered or is now fine, (1)
CL Item
your child's recovering but the illness/event is still present, (2)
CL Item
the illness/event is still present, (3)
CL Item
your child recovered from the acute (short-term) illness/event, but still has some symptom or condition as result of this event, (4)
Office visit
Item
Did your child require a physician office visit(s) that was not related to well-child care, vaccination, injury, or common illnesses such as upper respiratory infection, otitis media (middle ear inflammation), pharyngitis (sore throat), and gastroenteritis (stomach/intestinal illness)? [If yes,] I would like to ask you more about this illness/event that required a physician office visit.
boolean
C0028900 (UMLS CUI [1])
Office visit, Disease
Item
Briefly describe this illness/event (diagnosis if you have one) that your child had.
text
C0028900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
Office visit, Disease, Start Date
Item
On what date did this illness/event start?
date
C0028900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
Office visit, Disease, End Date
Item
On what date did this illness/event stop?
date
C0028900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
Item
How severe was this illness/event?
text
C0028900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,3])
Office visit, Disease, Severity
Code List
How severe was this illness/event?
CL Item
Was easily tolerated by your child, causing minimal discomfort and not interfering with everyday activities. (1)
CL Item
Was sufficiently discomforting to interfere with your child's normal everyday activities. (2)
CL Item
Prevented normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at a day-care center and would cause the parents/ guardians to seek medical advice.) (3)
Item
Which of the following best describes the outcome of your child's event/symptom:
text
C0028900 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C1547647 (UMLS CUI [1,3])
Office visit, Disease, Severity
Code List
Which of the following best describes the outcome of your child's event/symptom:
CL Item
your child recovered or is now fine, (1)
CL Item
your child's recovering but the illness/event is still present, (2)
CL Item
the illness/event is still present, (3)
CL Item
your child recovered from the acute (short-term) illness/event, but still has some symptom or condition as result of this event, (4)
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