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ID
34702
Beschreibung
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
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Versionen (1)
- 23.01.19 23.01.19 -
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GSK group of companies
Hochgeladen am
23. Januar 2019
DOI
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Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664
Visit 2: No Boost Only (UK)
- StudyEvent: ODM
Ähnliche Modelle
Visit 2: No Boost Only (UK)
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
CL Item
African Heritage/African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian-Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (10)
Other
Item
If Other, specify
text
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
History of H. influenzae type b, meningococcal or pertussis disease
Item
1. History of H. influenzae type b, meningococcal or pertussis diseases since the previous long-term persistence visit
boolean
PreviousAdministrationBoosterDose
Item
2. Previous administration of a booster dose of Hib or meningococcal serogroup C vaccines since the previous long-term persistence visit
boolean
immunosuppressants
Item
3. Chronic administration (defined as more than 14 days) of immunosuppressants or other immunemodifying drugs since the last visit.
boolean
immunoglobulins
Item
4. Administration of immunoglobulins and/or any blood products within 6 months prior to each persistence visit
boolean
Inclusion criteria for parents/guardians
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
Inclusion criteria age
Item
2. A male or female between, and including, 6 to 12 weeks of age at the time of the first vaccination
boolean
Inclusion criteria informed consent
Item
3. Written informed consent obtained from the parent or guardian of the subject
boolean
Inclusion Criteria Health
Item
4. Free of obvious health problems as established by medical history and clinical examination before entering into the study
boolean
Inclusion criteria previous study
Item
5. Having completed the booster vaccination study HIB-MENC-TT-013 BST:012
boolean
Exclusion criteria 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
Exclusion criteria previous History of Haemophilus influenzae type b and/or meningococcal diseases
Item
2. History of Haemophilus influenzae type b and/or meningococcal diseases
boolean
Treatment Allocation
Item
Record treatment number
integer
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 Hib disease since birth?
text
Code List
Has the subject received any vaccination against Hib disease since birth?
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
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
Date
Item
Record the date
date
Pre-Vaccination Temperature
Item
Pre-Vaccination Temperature
float
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Rectal (3)
CL Item
InfrarixTM-IPV Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Wrong vial number
Item
Record wrong vial number
integer
CL Item
Menitorix Vaccine (1)
CL Item
Replacement vial (2)
CL Item
Wrong vial number (3)
CL Item
Not administered (4)
Wrong vial number
Item
Record wrong vial number
integer
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Other (2)
SAEnumber
Item
Please specify the SAE number
integer
Other, specify
Item
If Other, please specify
text
CL Item
Investigator (1)
CL Item
Subject (2)
CL Item
Parents/Guardians (3)
SAEReminder
Item
If any adverse events occurred during the immediate post-vacconation period time (30 min) please fill in Serious Adverse Event form
text
Item
Has the subject experienced any serious adverse events within one month (minimum 30 days) following Infrarix-IPV and the Hib catch-up vaccine (Menitorix) administration?
text
Code List
Has the subject experienced any serious adverse events within one month (minimum 30 days) following Infrarix-IPV and the Hib catch-up vaccine (Menitorix) administration?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
TelephoneContact
Item
Has the subject been contacted?
boolean
Date of Contact
Item
Date of Contact
date
Occurrence of Serious Adverse Event
Item
Did the subject experience any Serious Adverse Event?
boolean
TotalNumberofSAE
Item
Specify total number of SAEs
integer
PreviousStudyDisease
Item
Has the subject experienced any Meningococcal, Hib or Pertussis disease?
boolean
INVESTIGATOR'S SIGNATURE
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