ID

23224

Description

Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 2: 30 – 42 days after Visit 1

Lien

https://clinicaltrials.gov/ct2/show/NCT00317161

Mots-clés

Hepatitis-B-Vakzine

Klinische Studie [Dokumenttyp]

Kleinkind

Vakzination

29/06/2017 29/06/2017 -

Téléchargé le

29 juin 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 2 NCT00317161

model
Détails

Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 Formulaires

StudyEvent: ODM
1. Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

Name

Type

Description | Question | Decode (Coded Value)

Type de données

Alias

Check for Study Continuation

Item Group

Check for Study Continuation

C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)

subject return for visit 2

Item

Did the subject return for visit 2 ?

integer

C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

subject come at visit 2

Code List

Did the subject return for visit 2 ?

CL Item

Yes, please complete the next pages. (1)

CL Item

No, please specify (2)

reason for study discontinuation

Item

Please tick the ONE most appropriate reason and skip the following pages of this visit.

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Code List

Please tick the ONE most appropriate reason and skip the following pages of this visit.

CL Item

Serious adverse event (1)

CL Item

Non-Serious adverse event (2)

CL Item

Other (3)

SAE Number

Item

SAE Number

integer

C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

AE Number

Item

AE Number or Code

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Other reason for Study Discontinuation

Item

Other reason for Study Discontinuation

text

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Item

reason for study discontinuation

integer

C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])

reason for study discontinuation

Code List

reason for study discontinuation

CL Item

Investigator (1)

CL Item

Parents/Guardians (2)

Laboratory Tests

Item Group

Laboratory Tests

C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)

blood sample

Item

Has a blood sample been taken?

boolean

C0005834 (UMLS CUI [1])

Protocol required Concomitant Vaccination

Item Group

Protocol required Concomitant Vaccination

C2347852 (UMLS CUI-1)
C0771080 (UMLS CUI-2)
C0078048 (UMLS CUI-3)

Japanese encephalitis

Item

Japanese encephalitis

boolean

C0771080 (UMLS CUI [1])

Japanese encephalitis Date

Item

Japanese encephalitis Date

date

C0771080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Varicella

Item

Varicella

boolean

C0078048 (UMLS CUI [1])

Varicella date

Item

Varicella date

date

C0078048 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Large Swelling Reaction

Item Group

Large Swelling Reaction

C0038999 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0443286 (UMLS CUI-3)

Vaccine administered

Item

Vaccine administered for which the large swelling reaction reported:

integer

C0042210 (UMLS CUI [1])

Vaccine administered

Code List

Vaccine administered for which the large swelling reaction reported:

CL Item

DTPw-HBV/Hib-MenAC Vaccine (1)

CL Item

DTPw-HBV/Hib Vaccine (2)

CL Item

Meningitec Vaccine (3)

Date of physical examination

Item

Date of physical examination

date

C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

performer of examination

Item

Was the examination performed by a member of study personnel during the large swelling reaction period:

boolean

C0031809 (UMLS CUI [1,1])
C0025082 (UMLS CUI [1,2])

Date when the swelling was first considered to be a large swelling reaction:

Item

Date when the swelling was first considered to be a large swelling reaction:

date

C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

hours after vaccination

Item

If occurring within 24 hours after vaccination, please specify how long after vaccination:

float

C0038999 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])

Size of swelling

Item

Measurement of the greatest diameter:

float

C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])

Type of swelling

Item

Type of swelling:

text

C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])

Type of swelling

Code List

Type of swelling:

CL Item

Local swelling around injection site, not involving adjacent joint (1)

CL Item

Diffuse swelling, not involving adjacent joint (2)

CL Item

Swelling, involving adjacent joint (3)

Circumference

Item

Circumference of swollen limb (at the site of maximum swelling):

float

C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])

Circumference

Item

Circumference of the opposite limb (at the same level):

float

C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])

Temperature

Item

Associated signs: Temperature

float

C0005903 (UMLS CUI [1])

Temperature Route

Item

Temperature Route

text

C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])

Temperature Route

Code List

Temperature Route

CL Item

Axillary (A)

CL Item

Oral (O)

CL Item

Rectal (R)

Redness

Item

Associated signs: Redness

boolean

C0332575 (UMLS CUI [1])

Redness largest diameter

Item

Redness, largest diameter

float

C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])

Induration

Item

Associated signs: Induration

boolean

C0332534 (UMLS CUI [1])

Induration largest diameter

Item

Induration, largest diameter

float

C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])

Pain

Item

Associated signs: Pain (at administration site)

boolean

C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Pain

Item

Pain, Intensity

integer

C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Pain

Code List

Pain, Intensity

CL Item

grade 1, Minor reaction to touch (1)

CL Item

grade 2, Cries / protests on touch (2)

CL Item

grade 3, Cries when limb is move (3)

Functional impairment

Item

Associated signs: Functional impairment

boolean

C4062321 (UMLS CUI [1])

Functional impairment

Item

Functional impairment, Intensity

integer

C4062321 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])

Functional impairment

Code List

Functional impairment, Intensity

CL Item

Grade 1, Easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)

CL Item

Grade 2, Sufficiently discomforting to interfere with normal everyday activities (2)

CL Item

Grade 3, Prevents normal everyday activities (3)

Case description

Item

Case description

text

C0449437 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])

Last date of swelling

Item

Last date when the swelling was still considered to be large swelling reaction:

date

C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

duration swelling

Item

If lasting for less than 24 hours, please specify duration (hours):

float

C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])

Outcome of the large swelling reaction:

Item

Outcome of the large swelling reaction: swelling reaction:

integer

C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])

Outcome of the large swelling reaction:

Code List

Outcome of the large swelling reaction: swelling reaction:

CL Item

Recovered / resolved (1)

CL Item

Recovering / resolving (2)

CL Item

Not recovered / not resolved (3)

CL Item

Recovered with sequelae / resolved with sequelae (4)

alternative explanation

Item

Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)

boolean

C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])

alternative explanation

Item

Alternative explanation. If Yes, please specify

text

C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])

Concomitant Vaccination

Item Group

Concomitant Vaccination

C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)

Subject Number

Item

Subject Number

text

C2348585 (UMLS CUI [1])

vaccine

Item

Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?

integer

C0042210 (UMLS CUI [1])

vaccine

Code List

Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?

CL Item

No (1)

CL Item

Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)

Name

Item

Trade/Generic Name

text

C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Route

Item

Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Route

Code List

Route

CL Item

Intradermal (ID)

CL Item

Inhalation (IH)

CL Item

Intramuscular (IM)

CL Item

Intravenous (IV)

CL Item

Intranasal (NA)

CL Item

Other (OTH)

CL Item

Parenteral (PE)

CL Item

Oral (PO)

CL Item

Subcutaneous (SC)

CL Item

Sublingual (SL)

CL Item

Transdermal (TD)

CL Item

Unknown (UNK)

Administration date

Item

Administration date

date

C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Medication

Item Group

Medication

C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)

Medication

Item

Have any medications/treatments been administered during study period?

integer

C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])

Medication

Code List

Have any medications/treatments been administered during study period?

CL Item

No (1)

CL Item

Yes, please complete the following table. (2)

Medication name

Item

Trade or generic name

text

C2360065 (UMLS CUI [1])

Indication

Item

Medical Indication

text

C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Prophylactic

Item

Medical Indication: Prophylactic?

boolean

C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])

Total daily dose

Item

Total daily dose

text

C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Administration Route

Item

Route

text

C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Administration Route

Code List

Route

CL Item

External (EXT)

CL Item

Intradermal (ID)

CL Item

Inhalation (IH)

CL Item

Intramuscular (IM)

CL Item

Intraarticular (IR)

CL Item

Intrathecal (IT)

CL Item

Intravenous (IV)

CL Item

Intranasal (NA)

CL Item

Other (OTH)

CL Item

Parenteral (PE)

CL Item

Oral (PO)

CL Item

Rectal (PR)

CL Item

Subcutaneous (SC)

CL Item

Sublingual (SL)

CL Item

Transdermal (TD)

CL Item

Topical (TO)

CL Item

Unknown (UNK)

CL Item

Vaginal (VA)

Medication Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Medication End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])

Medication Ongoing

Item

Medication Ongoing: tick box if continuing at end of study

boolean

C2826666 (UMLS CUI [1])

Non-serious Adverse Events

Item Group

Non-serious Adverse Events

C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)

Subject Number

Item

Subject Number

text

C2348585 (UMLS CUI [1])

non-serious adverse events

Item

Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?

integer

C1518404 (UMLS CUI [1])

Withdrawal

Code List

Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?

CL Item

No (1)

CL Item

Yes, please complete the following table (2)

Adverse Event Number

Item

Adverse Event Number

integer

C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])

Description

Item

Non-serious adverse events: Description

text

C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Description

Item

Non-serious adverse events: Description

integer

C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Description

Code List

Non-serious adverse events: Description

CL Item

Administration sites (1)

CL Item

Non-administration site (2)

Type of vaccine

Item

Non-serious adverse events: Description, Type of vaccine

integer

C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])

Type of vaccine

Code List

Non-serious adverse events: Description, Type of vaccine

CL Item

DTPw-HBV/Hib-MenAC vaccine (1)

CL Item

DTPw-HBV/Hib vaccine (2)

CL Item

Meningitec vaccine (3)

Start Date

Item

Start Date

date

C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Start

Item

Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)

boolean

C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

End Date

Item

End Date

date

C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Maximum Intensity

Item

Maximum Intensity

integer

C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Withdrawal

Code List

Maximum Intensity

CL Item

Mild (1)

CL Item

Modearte (2)

CL Item

Severe (3)

Relationship to investigational product(s)

Item

Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?

boolean

C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])

Outcome

Item

Outcome

text

C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])

Outcome

Code List

Outcome

CL Item

Recovered / Resolved (1)

CL Item

Recovering / resolving (2)

CL Item

Not recovered / not resolved (3)

CL Item

Recovered with sequelae / Resolved with sequelae (4)

Medically attended visit

Item

Medically attended visit?

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])

Medically attended visit type

Item

Medically attended visit type

text

C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])

Medical advice type

Code List

Medically attended visit type

CL Item

Hospitalisation (HO)

CL Item

Emergency room (ER)

CL Item

Medical doctor (MD)

Retour au début de la page

ID

Description

Lien

Mots-clés

Versions (1)

Téléchargé le

DOI

Licence

Modèle Commentaires :

Groupe Item commentaires pour :

Item commentaires pour :

Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 2 NCT00317161

Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Unités de mesure

Alias

Description

Type de données

Alias

Description

Type de données

Unités de mesure