ID
34015
Beschrijving
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
Trefwoorden
Versies (1)
- 11-01-19 11-01-19 -
Houder van rechten
GSK group of companies
Geüploaded op
11 januari 2019
DOI
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Licentie
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
Beschrijving
Elimination Criteria During The Study
Beschrijving
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
Beschrijving
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
Beschrijving
(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
Beschrijving
Contraindications To Subsequent Vaccination
Beschrijving
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
Beschrijving
1. Anaphylactic reaction following the administration of vaccine(s)
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text
Beschrijving
2. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
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text
Beschrijving
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.
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text
Beschrijving
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
Beschrijving
2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
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text
Beschrijving
Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
Beschrijving
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
Beschrijving
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
Beschrijving
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
Beschrijving
Precautions for Vaccination
Beschrijving
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
Beschrijving
As with other vaccines, the administration of MeningitecTM should be postponed in subjects suffering from acute febrile illness
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text
Beschrijving
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
Datatype
text
Beschrijving
If Other, please specify
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text
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Eligibility Check
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Inclusion Criteria
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Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Tick "Yes" if the subject fulfilled the criterion
Datatype
boolean
Beschrijving
Exclusion Criteria
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
(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
Datatype
boolean
Beschrijving
(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
Datatype
boolean
Beschrijving
Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatype
boolean
Beschrijving
Randomisation / Treatment Allocation
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Physical Examination
Beschrijving
If Yes, please tick appropriate box(es) and give diagnosis below
Datatype
boolean
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Diagnosis
Datatype
text
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Status
Datatype
integer
Beschrijving
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
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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
Beschrijving
Vaccine History
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Laboratory Tests - Blood
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Vaccine Administration
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Vaccine
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Tick ONLY one box by vaccine
Datatype
text
Beschrijving
If replacement vial, please record the number
Datatype
integer
Beschrijving
If wrong vial, please record the number
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text
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according to Protocol
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text
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according to Protocol
Datatype
text
Beschrijving
according to Protocol
Datatype
text
Beschrijving
If No, please tick below all items that apply
Datatype
boolean
Beschrijving
Side
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text
Beschrijving
Site
Datatype
text
Beschrijving
Route
Datatype
text
Beschrijving
Vaccine 2
Beschrijving
Tick ONLY one box by vaccine
Datatype
text
Beschrijving
If replacement vial, please record the number
Datatype
integer
Beschrijving
If wrong vial, please record the number
Datatype
integer
Beschrijving
According to protocol
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text
Beschrijving
According to protocol
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text
Beschrijving
According to protocol
Datatype
text
Beschrijving
If No, please tick below all items that apply
Datatype
boolean
Beschrijving
Side
Datatype
text
Beschrijving
Site
Datatype
text
Beschrijving
Route
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text
Beschrijving
Comments
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text
Beschrijving
Non-administration
Beschrijving
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.
Datatype
text
Beschrijving
If Other, please specify
Datatype
text
Beschrijving
If SAE, record the SAE number
Datatype
integer
Beschrijving
If non-SAE, please record the AE number
Datatype
integer
Beschrijving
Unsolicited Adverse Events
Beschrijving
Solicited Adverse Events - Local Symptoms
Beschrijving
Hib-MenC vaccine or MeningitecTM vaccine
Datatype
integer
Beschrijving
Day
Datatype
integer
Beschrijving
If Redness, record size
Datatype
float
Maateenheden
- mm
Beschrijving
If Swelling, record size
Datatype
float
Maateenheden
- mm
Beschrijving
If Pain, record Intensity
Datatype
text
Beschrijving
Ongoing after day 3?
Datatype
boolean
Beschrijving
Date of last day of symptoms
Datatype
date
Beschrijving
Medically attended visit?
Datatype
boolean
Beschrijving
If Yes, please record type
Datatype
text
Beschrijving
Solicited Adverse Events - Local Symptoms - Vaccine 2
Beschrijving
InfanrixTM-IPV vaccine or PediacelTM vaccine
Datatype
integer
Beschrijving
Day
Datatype
integer
Beschrijving
If Redness, record size
Datatype
float
Maateenheden
- mm
Beschrijving
If Swelling, record size
Datatype
float
Maateenheden
- mm
Beschrijving
If Pain, record Intensity
Datatype
integer
Beschrijving
Ongoing after day 3?
Datatype
boolean
Beschrijving
Date of last day of symptoms
Datatype
date
Beschrijving
medically attended visit?
Datatype
boolean
Beschrijving
If Yes, please record type
Datatype
text
Beschrijving
Solicited Adverse Events
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General Symptoms
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Symptom
Datatype
integer
Beschrijving
Day
Datatype
integer
Beschrijving
preferably axillary! Axillary >= 37.5°C Rectal >=38°C
Datatype
float
Maateenheden
- °C
Beschrijving
If Irritability / Fussiness , record intensity
Datatype
text
Beschrijving
If Drowsiness, record intensity
Datatype
integer
Beschrijving
If Loss of appetite, record intensity
Datatype
text
Beschrijving
Ongoing after day 3?
Datatype
boolean
Beschrijving
Date of last day of symptoms
Datatype
date
Beschrijving
Causality
Datatype
boolean
Beschrijving
Medically attended visit?
Datatype
boolean
Beschrijving
If Yes, record the type
Datatype
integer
Similar models
Visit 5
- StudyEvent: ODM