Information:
Fel:
ID
34071
Beskrivning
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis
Nyckelord
Versioner (1)
- 2019-01-14 2019-01-14 -
Rättsinnehavare
GSK group of companies
Uppladdad den
14 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664
Visit 1: Eligibility Criteria, Physical Examination, Vaccination, Non Participation, Use of Human Samples Consent
Similar models
Visit 1: Eligibility Criteria, Physical Examination, Vaccination, Non Participation, Use of Human Samples Consent
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Date of Visit
Item
Date of Visit
date
Subject Number
Item
Subject Number
integer
InformedConsent
Item
I certify that Informed Consent has been obtained prior to any procedure. Date below
date
Item
Did the suject agree that her/his biological sample(s) may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
text
Code List
Did the suject agree that her/his biological sample(s) may be used by GSK Biologicals for further research that is NOT RELATED to the vaccine(s) or the disease(s) under study?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Center Number
Item
Center Number
integer
Date of Birth
Item
Date of Birth
date
CL Item
Male (1)
CL Item
Female (2)
EntryCriteriaMet
Item
Did the subject meet all the entry criteria?
boolean
Do not enter the subject into the study if he/she failed any inclusion criteria below
Item
Do not enter the subject into the study if he/she failed any inclusion criteria below.
text
1. Parents/guardians of the subject can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) according to the investigator's opinion
Item
1. Parents/guardians of the subject can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) according to the investigator's opinion
boolean
2. A male or female between, and including, 6 to 12 weeks of age at the time of the first vaccination
Item
2. A male or female between, and including, 6 to 12 weeks of age at the time of the first vaccination
boolean
3. Written informed consent obtained from the parent or guardian of the subject
Item
3. Written informed consent obtained from the parent or guardian of the subject
boolean
Healthy subjects
Item
4. Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
undefined item
Item
5. Having completed the booster vaccination study HIB-MENC-TT-013 BST:012
boolean
previous administration of booster dose
Item
1. Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study BID-MENC-TT-013 BST:012 (104056)
boolean
previous History of Haemophilus influenzae type b and/or meningococcal diseases
Item
2. History of Haemophilus influenzae type b and/or meningococcal diseases
boolean
previous administration of a booster dose of a pertussis-containing vaccine
Item
3. UK SUBJECTS ONLY: previous administration of a booster dose of a pertussis-containing vaccine
boolean
Item Group
General Medical History / Physical Examination
pre-existing conditions
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
Skin and subcutaneous tissue
Item
Skin and subcutaneous tissue
text
CL Item
Past (1)
CL Item
Current (2)
Muskuloskeletal and connective tissue
Item
Muskuloskeletal and connective tissue
text
CL Item
Past (1)
CL Item
Current (2)
Cardiac
Item
Cardiac
text
CL Item
Past (1)
CL Item
Current (2)
CL Item
Past (1)
CL Item
Current (2)
CL Item
Past (1)
CL Item
Current (2)
Respiratory, thoracic and mediastinal
Item
Respiratory, thoracic and mediastinal
text
CL Item
Past (1)
CL Item
Current (2)
Gastrointestinal
Item
Gastrointestinal
text
CL Item
Past (1)
CL Item
Current (2)
Hepatobiliary
Item
Hepatobiliary
text
CL Item
Past (1)
CL Item
Current (2)
Renal and urinary
Item
Renal and urinary
text
CL Item
Past (1)
CL Item
Current (2)
Nervous system
Item
Nervous system
text
CL Item
Past (1)
CL Item
Current (2)
Eye
Item
Eye
text
CL Item
Past (1)
CL Item
Current (2)
Ear and labyrinth
Item
Ear and labyrinth
text
CL Item
Past (1)
CL Item
Current (2)
Endocrine
Item
Endocrine
text
CL Item
Past (1)
CL Item
Current (2)
Metabolism and nutrition
Item
Metabolism and nutrition
text
CL Item
Past (1)
CL Item
Current (2)
Blood and lymphatic system
Item
Blood and lymphatic system
text
CL Item
Past (1)
CL Item
Current (2)
Immune system
Item
Immune system
text
CL Item
Past (1)
CL Item
Current (2)
Infections and infestations
Item
Infections and infestations
text
CL Item
Past (1)
CL Item
Current (2)
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
Item
Neoplasms benign, malignant and unspecified (incl cysts, polyps)
text
CL Item
Past (1)
CL Item
Current (2)
Surgical and medical procedures
Item
Surgical and medical procedures
text
CL Item
Past (1)
CL Item
Current (2)
Item
Has the subject received any vaccination against meningococcal disease since last visit?
integer
Code List
Has the subject received any vaccination against meningococcal disease since last visit?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Trade / Generic Name
Item
Trade / Generic Name
text
Dose Number
Item
Dose Number
text
VaccineDate
Item
Estimated date of vaccine
date
Item
Has the subject received any vaccination against pertussis disease since last visit?
text
Code List
Has the subject received any vaccination against pertussis disease since last visit?
CL Item
No (1)
CL Item
Unknown (2)
CL Item
Yes (3)
Trade / Generic Name
Item
Trade / Generic Name
text
Dose Number
Item
Dose Number
text
VaccineDate
Item
Estimated date of vaccine
date
Item
Previous history of meningococcal disease since last visit?
text
Code List
Previous history of meningococcal disease since last visit?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
diagnosis
Item
Please specify the diagnosis
text
estimated date
Item
Please record estimated date
date
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
diagnosis
Item
Please specify the diagnosis
text
estimated date
Item
Please record estimated date
date
Item
Previous history of Pertussis disease since last visit?
text
Code List
Previous history of Pertussis disease since last visit?
CL Item
Yes (1)
CL Item
No (2)
CL Item
Unknown (3)
diagnosis
Item
Please specify the diagnosis
text
estimated date
Item
Please record estimated date
date
blood sample
Item
Has a blood sample for antibodies determination been taken?
boolean
Date sample taken
Item
Please record the date sample taken
date
concomitant medication/treatment
Item
Have any relevant medications/treatments been administered since the last visit?
boolean
Trade/Generic Name
Item
Trade/Generic Name
text
Prophylactic
Item
Was the treatment prophylactic?
boolean
medical indication
Item
If no, record medical indication
text
Total daily dose
Item
Total daily dose
text
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Vaginal (11)
CL Item
Unknown (12)
CL Item
Other (13)
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing medication
Item
Is the medication/treatment continuing?
boolean
SAE
Item
Did the subject experience any Serious Adverse Events since last visit?
boolean
total number of SAEs
Item
If Yes, please specify the total number of SAEs
integer
SAE relationship to the vaccination?
Item
Have the SAEs forms determined the relationship to the vaccination?
boolean
case of meningitis
Item
Has the subject experienced any meningitis?
boolean
If Yes, please complete the meningitis page
Item
If Yes, please complete the meningitis page
text
Investigator's Confirmation
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's Signature
Item
Investigator's Signature
text
Printed Investigator's Name
Item
Printed Investigator's Name
text
Previous Subject Number
Item
Previous Subject Number
integer
Date of Birth
Item
Date of Birth
date
CL Item
Subject not eligible - Please specify below criteria that are not fulfilled (1)
CL Item
Subject lost to follow-up or not reached (2)
CL Item
Subject eligible but not willing to participate (please specify the reason below) (3)
CL Item
Subject died (record the date below) (4)
criteria for subject ineligibility
Item
If Subject not eligible, please specify criteria that are not fulfilled
text
Item
If Subject is not wiling to participate, record reason
text
CL Item
Adverse event(s), or serious adverse event (1)
CL Item
Other (2)
If AE/SAE, please record details
Item
If AE/SAE, please record details
text
If Other, please specify
Item
If Other, please specify
text
DeathDate
Item
In case of death, record the date
date
Date of Contact
Item
Date of Contact
date
Investigator's name
Item
Investigator's name
text
Signature
Item
Signature
text
Date
Item
Date
date
Informed Consent
Item
Please tick in the following sections what is also covered y the subject Informed Consent form of your center.
text
Quality Assurance of tests described in the protocol
Item
Was Informed consent for quality Assurance of tests described in the protocol obtained?
boolean
Informed Consent for further investigation
Item
Was the Informed Consent obtained for further investigation by GSK Biologicals into the ability of the vaccine to protect people if any findings from related studies require it and further research in the disease(s) under study.
boolean
Informed Consent for further research
Item
Further research by GSK Biologicals that is NOT RELATED to the vaccine(s) or the disease(s) under study done on an anonymous basis (meaning that any identification linking the subject to the sample is destroyed).
boolean
Item
Please tick below if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center
text
Code List
Please tick below if a 15 years GSK storage period is covered by the subject's Informed Consent form of your center
CL Item
At lest 15 years storage period by GSK Biologicals (1)
CL Item
Other (2)
If Other, please specify
Item
If Other, please specify
text
ICF Effective Date
Item
ICF Effective Date
date
Investigator's Signature
Item
Investigator's Signature
text
Printed Investigator's Name
Item
Printed Investigator's Name
text
Date
Item
Date
date