ID
34015
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)
- 2019-01-11 2019-01-11 -
Rättsinnehavare
GSK group of companies
Uppladdad den
11 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 - 104056
Visit 5
- StudyEvent: ODM
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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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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
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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
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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
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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
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2. Axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C
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text
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Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines
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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
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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
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Precautions for Vaccination
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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
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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
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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
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boolean
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Tick "Yes" if the subject fulfilled the criterion
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boolean
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Tick "Yes" if the subject fulfilled the criterion
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boolean
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Tick "Yes" if the subject fulfilled the criterion
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boolean
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Tick "Yes" if the subject fulfilled the criterion
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boolean
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Tick "Yes" if the subject fulfilled the criterion
Datatyp
boolean
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Exclusion Criteria
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
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boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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(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
Datatyp
boolean
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(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
Datatyp
boolean
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Tick "Yes" if the given criterion can be applied to the subject and disqualifies him/her from the study
Datatyp
boolean
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Randomisation / Treatment Allocation
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Physical Examination
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If Yes, please tick appropriate box(es) and give diagnosis below
Datatyp
boolean
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Diagnosis
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text
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Status
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integer
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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
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Diagnosis
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text
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Status
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text
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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
Datatyp
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
text
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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
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text
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If No, please tick below all items that apply
Datatyp
boolean
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Side
Datatyp
text
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Site
Datatyp
text
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Route
Datatyp
text
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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, 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
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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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Comments
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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.
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text
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If Other, please specify
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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
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integer
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Day
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integer
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If Redness, record size
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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
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date
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Medically attended visit?
Datatyp
boolean
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If Yes, please record type
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text
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Solicited Adverse Events - Local Symptoms - Vaccine 2
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InfanrixTM-IPV vaccine or PediacelTM vaccine
Datatyp
integer
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Day
Datatyp
integer
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If Redness, record size
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float
Måttenheter
- mm
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If Swelling, record size
Datatyp
float
Måttenheter
- mm
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If Pain, record Intensity
Datatyp
integer
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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
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General Symptoms
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Symptom
Datatyp
integer
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Day
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integer
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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 intensity
Datatyp
text
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If Drowsiness, record intensity
Datatyp
integer
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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
integer
Similar models
Visit 5
- StudyEvent: ODM