ID
34015
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
Stichworte
Versionen (1)
- 11.01.19 11.01.19 -
Rechteinhaber
GSK group of companies
Hochgeladen am
11. Januar 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056
Visit 5
- StudyEvent: ODM
Beschreibung
Elimination Criteria During The Study
Beschreibung
If any of the criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.
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integer
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1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
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text
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(For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed)
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text
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3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
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text
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4. Administration of immunoglobulins and/or any blood products during the study period
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text
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Contraindications To Subsequent Vaccination
Beschreibung
The following adverse events (AEs) constitute ABSOLUTE contraindications to further administration of study vaccines; if any of these occur during the study, the subject must not receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
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text
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1. Anaphylactic reaction following the administration of vaccine(s)
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text
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2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
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text
Beschreibung
The following AEs constitute contraindications to further administration of study vaccines; if any of these occur during the study, the subject may be vaccinated at a later date within the time window specified in the protocol, or withdrawn at the dscretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
Datentyp
text
Beschreibung
Acute disease is defined as 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 Rectal temperature <38.0°C/Axillary temperature <37.5°C
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text
Beschreibung
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
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text
Beschreibung
Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
Beschreibung
If any of these adverse experiences occurred following previous vaccinations during the study, the subject should be withdrawn from the study
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text
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1. Known hypersensitivity to any component of the vaccines. It should be noted that in the IPV component, trace levels of neomycin sulfate, streptomycin and polymyxin B may be present
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text
Beschreibung
not due to another identifiable cause. This is defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination,, and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours. Even though causation by DTP vaccine cannot be established, no subsequent doses of pertussis vaccine should be given. The vaccination course can be continued with diphtheria-tetanus, hepatitis B, inactivated polio and Hi vaccines (the subject will be eliminated from the study)
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text
Beschreibung
Precautions for Vaccination
Beschreibung
Administration of InfarixTM-IPV or PediacelTM should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection is NOT a contraindication. Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccines.
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text
Beschreibung
As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness
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text
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Informed Consent
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Demographics
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Center Number
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integer
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Date of birth
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date
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Gender
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text
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Race
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text
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If Other, please specify
Datentyp
text
Beschreibung
Eligibility Check
Beschreibung
Inclusion Criteria
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
Datentyp
boolean
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
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boolean
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
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boolean
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
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boolean
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
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boolean
Beschreibung
Tick "Yes" if the subject fulfilled the criterion
Datentyp
boolean
Beschreibung
Exclusion Criteria
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
(one episode of febrile convulsion does not constitute an exclusion criterion). Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
(Acute disease is defined as 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. Rectal t° <38°C/Axillary t° < 37.5°C) Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datentyp
boolean
Beschreibung
Randomisation / Treatment Allocation
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Physical Examination
Beschreibung
If Yes, please tick appropriate box(es) and give diagnosis below
Datentyp
boolean
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Diagnosis
Datentyp
text
Beschreibung
Status
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integer
Beschreibung
Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
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Diagnosis
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text
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Status
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text
Beschreibung
Diagnosis
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text
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Status
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text
Beschreibung
Diagnosis
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text
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Status
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text
Beschreibung
Diagnosis
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text
Beschreibung
Status
Datentyp
text
Beschreibung
Vaccine History
Beschreibung
Laboratory Tests - Blood
Beschreibung
Vaccine Administration
Beschreibung
Vaccine
Beschreibung
Tick ONLY one box by vaccine
Datentyp
text
Beschreibung
If replacement vial, please record the number
Datentyp
integer
Beschreibung
If wrong vial, please record the number
Datentyp
text
Beschreibung
according to Protocol
Datentyp
text
Beschreibung
according to Protocol
Datentyp
text
Beschreibung
according to Protocol
Datentyp
text
Beschreibung
If No, please tick below all items that apply
Datentyp
boolean
Beschreibung
Side
Datentyp
text
Beschreibung
Site
Datentyp
text
Beschreibung
Route
Datentyp
text
Beschreibung
Vaccine 2
Beschreibung
Tick ONLY one box by vaccine
Datentyp
text
Beschreibung
If replacement vial, please record the number
Datentyp
integer
Beschreibung
If wrong vial, please record the number
Datentyp
integer
Beschreibung
According to protocol
Datentyp
text
Beschreibung
According to protocol
Datentyp
text
Beschreibung
According to protocol
Datentyp
text
Beschreibung
If No, please tick below all items that apply
Datentyp
boolean
Beschreibung
Side
Datentyp
text
Beschreibung
Site
Datentyp
text
Beschreibung
Route
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text
Beschreibung
Comments
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text
Beschreibung
Non-administration
Beschreibung
If any AE occurred during the immediate post-vaccination time (30 min) please fill in the Solicited AE section, the Non-SAE section or a SAE form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section.
Datentyp
text
Beschreibung
If Other, please specify
Datentyp
text
Beschreibung
If SAE, record the SAE number
Datentyp
integer
Beschreibung
If non-SAE, please record the AE number
Datentyp
integer
Beschreibung
Unsolicited Adverse Events
Beschreibung
Solicited Adverse Events - Local Symptoms
Beschreibung
Hib-MenC vaccine or MeningitecTM vaccine
Datentyp
integer
Beschreibung
Day
Datentyp
integer
Beschreibung
If Redness, record size
Datentyp
float
Maßeinheiten
- mm
Beschreibung
If Swelling, record size
Datentyp
float
Maßeinheiten
- mm
Beschreibung
If Pain, record Intensity
Datentyp
text
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Beschreibung
Date of last day of symptoms
Datentyp
date
Beschreibung
Medically attended visit?
Datentyp
boolean
Beschreibung
If Yes, please record type
Datentyp
text
Beschreibung
Solicited Adverse Events - Local Symptoms - Vaccine 2
Beschreibung
InfanrixTM-IPV vaccine or PediacelTM vaccine
Datentyp
integer
Beschreibung
Day
Datentyp
integer
Beschreibung
If Redness, record size
Datentyp
float
Maßeinheiten
- mm
Beschreibung
If Swelling, record size
Datentyp
float
Maßeinheiten
- mm
Beschreibung
If Pain, record Intensity
Datentyp
integer
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Beschreibung
Date of last day of symptoms
Datentyp
date
Beschreibung
medically attended visit?
Datentyp
boolean
Beschreibung
If Yes, please record type
Datentyp
text
Beschreibung
Solicited Adverse Events
Beschreibung
General Symptoms
Beschreibung
Symptom
Datentyp
integer
Beschreibung
Day
Datentyp
integer
Beschreibung
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
Datentyp
float
Maßeinheiten
- °C
Beschreibung
If Irritability / Fussiness , record intensity
Datentyp
text
Beschreibung
If Drowsiness, record intensity
Datentyp
integer
Beschreibung
If Loss of appetite, record intensity
Datentyp
text
Beschreibung
Ongoing after day 3?
Datentyp
boolean
Beschreibung
Date of last day of symptoms
Datentyp
date
Beschreibung
Causality
Datentyp
boolean
Beschreibung
Medically attended visit?
Datentyp
boolean
Beschreibung
If Yes, record the type
Datentyp
integer
Ähnliche Modelle
Visit 5
- StudyEvent: ODM