ID
33959
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)
- 2019-01-09 2019-01-09 -
Rättsinnehavare
GSK group of companies
Uppladdad den
9 januari 2019
DOI
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Licens
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974
Visit 3: Vaccine Administration, Eligibility Criteria, Symptoms, Adverse Events Forms
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Check for Study Continuation
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Did the subject return for Visit 3?
Datatyp
boolean
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If No, please tick ONE most appropriate reason
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text
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If Other, please specify
Datatyp
text
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If SAE, record the SAE number
Datatyp
integer
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If non-SAE, please record the AE number
Datatyp
integer
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Please tick who took the decision
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text
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Elimination Criteria During The Study
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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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text
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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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2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
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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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Vaccine Administration - Vaccine 1
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fill in only if different from visit date
Datatyp
date
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Pre-Vaccination temperature
Datatyp
float
Måttenheter
- °C
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Route
Datatyp
text
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Tick ONLY one box by vaccine
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text
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If replacement vial, please record the number
Datatyp
integer
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If wrong vial, please record the number
Datatyp
integer
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according to Protocol
Datatyp
text
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according to Protocol
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text
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according to Protocol
Datatyp
text
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If No, please tick below all items that apply
Datatyp
boolean
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Side
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text
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Site
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text
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Route
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text
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Vaccine Administration - Vaccine 2
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Tick ONLY one box by vaccine
Datatyp
text
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If Replacement vial, please record the number
Datatyp
integer
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If Wrong vial number, please record the number
Datatyp
integer
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According to Protocol
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text
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According to Protocol
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text
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According to Protocol
Datatyp
text
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If No, please tick below all items that apply
Datatyp
boolean
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Side
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text
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Site
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text
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Route
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text
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Non-administration
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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.
Datatyp
text
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If Other, please specify
Datatyp
text
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If SAE, record the SAE number
Datatyp
integer
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If non-SAE, please record the AE number
Datatyp
integer
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Unsolicited Adverse Events
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Solicited Adverse Events - Local Symptoms
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Hib-MenC vaccine or MeningitecTM vaccine
Datatyp
integer
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Day
Datatyp
integer
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If Redness, record size
Datatyp
float
Måttenheter
- mm
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If Swelling, record size
Datatyp
float
Måttenheter
- mm
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If Pain, record Intensity
Datatyp
text
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Ongoing after day 3?
Datatyp
boolean
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Date of last day of symptoms
Datatyp
date
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Medically attended visit?
Datatyp
boolean
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If Yes, please record type
Datatyp
text
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Solicited Adverse Events - Local Symptoms - Vaccine 2
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InfanrixTM-IPV vaccine or PediacelTM vaccine
Datatyp
text
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Day
Datatyp
text
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If Redness, record size
Datatyp
float
Måttenheter
- mm
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If Swelling, record size
Datatyp
float
Måttenheter
- mm
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If Pain, record Intensity
Datatyp
text
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Ongoing after day 3?
Datatyp
boolean
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Date of last day of symptoms
Datatyp
boolean
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medically attended visit?
Datatyp
boolean
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If Yes, please record type
Datatyp
text
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Solicited Adverse Events
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General Symptoms
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Symptom
Datatyp
text
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preferably axillary! Axillary >= 37.5°C Rectal >=38°C
Datatyp
float
Måttenheter
- °C
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If Irritability / Fussiness, record intens
Datatyp
text
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If Irritability / Fussiness, record intensity
Datatyp
text
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If Drowsiness, record intensity
Datatyp
text
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If Loss of appetite, record intensity
Datatyp
text
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Ongoing after day 3?
Datatyp
boolean
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Date of last day of symptoms
Datatyp
date
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Causality
Datatyp
boolean
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Medically attended visit?
Datatyp
boolean
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If Yes, record the type
Datatyp
text