ID

38429

Descripción

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form contains information on solicited adverse events (local and general symptoms ) in the first 3 days after the study vaccinations, as well as whether the subject has experienced unsolicited (serious) adverse events. Details of unsolicited adverse events are to be given in a different form. This form is to be filled in after the vaccination Visits, i.e. Visits 1, 2, 3 and 8 (all cohorts) and additionally Visit 5 for all cohorts except for the 3+0 schedule without the booster vaccination in HIV-negative subjects.

Palabras clave

Versiones (2)
  1. 2/9/19 2/9/19 -
  2. 17/10/19 17/10/19 - Sarah Riepenhausen
Titular de derechos de autor

GlaxoSmithKline

Subido en

17 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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    10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

    Inglés

    Solicited and unsolicited adverse events

    1 formularios  
    Administrative data
    Descripción

    Administrative data

    Alias
    UMLS CUI-1
    C1320722
    Subject Identifier
    Descripción

    Clinical Trial Subject Unique Identifier

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Cohort
    Descripción

    Cohort

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0599755
    Date of Assessment
    Descripción

    Date of Assessment

    Tipo de datos

    date

    Alias
    UMLS CUI [1]
    C2985720
    Dose preceding assessment
    Descripción

    Dose 1 is at Visit 1. Dose 2 is at Visit 2. Dose 3 is at Visit 3. The Booster Dose of 10Pn-PD-DiT is at Visit 5 (not applicable to the HIV-neg. cohort, 3+0 schedule ). The Booster Dose of DTPw-HBV/Hib is at Visit 8. Please note that in the 2+1 schedule HIV-neg. cohort, the pneumococcal study vaccine is not administered at Visit 2. However, this Visit is still designated as "Dose 2", as the second dose of the DTPw-HBV/Hib vaccine is administered at this Visit.

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C3174092
    UMLS CUI [1,2]
    C0332152
    UMLS CUI [1,3]
    C0220825
    Solicited Adverse Events - Local Symptoms
    Descripción

    Solicited Adverse Events - Local Symptoms

    Alias
    UMLS CUI-1
    C0877248
    UMLS CUI-2
    C1457887
    UMLS CUI-3
    C0205276
    Select vaccination
    Descripción

    Fill in entire item group once per vaccine The 10Pn-PD-DiT vaccine is administered at Visits 1 (all cohorts), 2 (all cohorts except the 2+1 schedule HIV-neg. cohort), 3 (all cohorts) and 5 (all cohorts except the EPI/3+0 schedule HIV-neg. cohort). The DTPw-HBV/Hib vaccine is administered at Visits 1, 2, 3 and 8 (all cohorts).

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0042196
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Descripción

    Redness, Swelling, Pain

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0037088
    UMLS CUI [1,2]
    C2700396
    UMLS CUI [1,3]
    C0347984
    UMLS CUI [1,4]
    C1948053
    Select symptom
    Descripción

    Fill in entire item group once per symptom

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1457887
    Presence of Symptom
    Descripción

    If yes, give either Size on Days 0-3 for Redness and Swelling or Pain Intensity on Days 0-3 for Pain. In case of large swelling reaction at the injected limb, please fill in ALSO the Large Swelling Reaction forms.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0150312
    Size Day 0
    Descripción

    for Redness and Swelling

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0456389
    mm
    Size Day 1
    Descripción

    for Redness and Swelling

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0456389
    mm
    Size Day 2
    Descripción

    for Redness and Swelling

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0456389
    mm
    Size Day 3
    Descripción

    for Redness and Swelling

    Tipo de datos

    integer

    Unidades de medida
    • mm
    Alias
    UMLS CUI [1]
    C0456389
    mm
    Pain intensity Day 0
    Descripción

    Intensity: 0 / 1 / 2 / 3

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 1
    Descripción

    Intensity: 0 / 1 / 2 / 3

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 2
    Descripción

    Intensity: 0 / 1 / 2 / 3

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Pain intensity Day 3
    Descripción

    Intensity: 0 / 1 / 2 / 3

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1320357
    Symptom ongoing after Day 3?
    Descripción

    if yes, give last day of symptoms in next item

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    If Symptom is ongoing after Day 3, record date of last Day of Symptoms
    Descripción

    Last Day of Symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C1457887
    Solicited Adverse Events - General Symptoms
    Descripción

    Solicited Adverse Events - General Symptoms

    Alias
    UMLS CUI-1
    C1457887
    UMLS CUI-2
    C0042196
    UMLS CUI-3
    C0877248
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    Descripción

    Fever, Irritability/Fussiness, Drowsiness, Loss of appetite; Diarrhoea, Vomiting (those two are only applicable after Visit 2 and 3, and only if the Rotavirus Vaccine has been administered)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0347984
    UMLS CUI [1,3]
    C1948053
    Select symptom
    Descripción

    Fill in entire item group once per symptom Diarrhoea and Vomiting are only applicable if HRV has been administered (Visit 2 and 3)

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C1457887
    Presence of Symptom
    Descripción

    If yes: For fever, selected route of measurement, answer whether fever has been measured on Days 0-3, and height of fever. For Irritability/Fussiness, Drowsiness and Loss of appetite, record symptom intensity on Days 0-3. For Vomiting and Diarrhoea (if appropriate), record number of vomiting/stool episodes per day on Days 0-3. Definition of fever: Axillary, Oral, Tympanic (oral conversion) >= 37.5 °C Rectal and Tympanic (rectal conversion) >= 38 °C

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0150312
    Fever, Site of measurement
    Descripción

    Fever, Site of measurement

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C0449687
    UMLS CUI [1,2]
    C0015967
    Temperature taken on Day 0?
    Descripción

    Temperature taken on Day 0?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0884358
    Fever on Day 0
    Descripción

    if taken, please specify

    Tipo de datos

    float

    Unidades de medida
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Temperature taken on Day 1?
    Descripción

    Temperature taken on Day 1?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0884358
    Fever on Day 1
    Descripción

    if taken, please specify

    Tipo de datos

    float

    Unidades de medida
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Temperature taken on Day 2?
    Descripción

    Temperature taken on Day 2?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0884358
    Fever on Day 2
    Descripción

    if taken, please specify

    Tipo de datos

    float

    Unidades de medida
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Temperature taken on Day 3?
    Descripción

    Temperature taken on Day 3?

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0886414
    UMLS CUI [1,2]
    C0884358
    Fever on Day 3
    Descripción

    if taken, please specify

    Tipo de datos

    float

    Unidades de medida
    • C
    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C0015967
    C
    Symptom Intensity on Day 0
    Descripción

    For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Symptom Intensity on Day 1
    Descripción

    For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Symptom Intensity on Day 2
    Descripción

    For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Symptom Intensity on Day 3
    Descripción

    For Irritability/Fussiness: 0 = Behavior as usual 1 = Crying more than usual / no effect on normal activity 2 = Crying more than usual / interferes with normal activity 3 = Crying that cannot be comforted / prevents normal activity For Drowsiness: 0 = Behavior as usual 1 = Drowsiness easily tolerated 2 = Drowsiness that interferes with normal activity 3 = Drowsiness that prevents normal activity For Loss of appetite: 0 = Appetite as usual 1 = Eating less than usual / no effect on normal activity 2 = Eating less than usual / interferes with normal activity 3 = Not eating at all

    Tipo de datos

    integer

    Alias
    UMLS CUI [1]
    C0518690
    Number of episodes on Day 0
    Descripción

    For Diarrhoae and Vomiting, record number of episodes per day

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0750480
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C0439505
    Number of episodes on Day 1
    Descripción

    For Diarrhoae and Vomiting, record number of episodes per day

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0750480
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C0439505
    Number of episodes on Day 2
    Descripción

    For Diarrhoae and Vomiting, record number of episodes per day

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0750480
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C0439505
    Number of episodes on Day 3
    Descripción

    For Diarrhoae and Vomiting, record number of episodes per day

    Tipo de datos

    integer

    Alias
    UMLS CUI [1,1]
    C0750480
    UMLS CUI [1,2]
    C0332189
    UMLS CUI [1,3]
    C0439505
    Symptom ongoing after Day 3?
    Descripción

    if yes, give last day of symptoms in next item

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1457887
    UMLS CUI [1,2]
    C0549178
    If Symptom is ongoing after Day 3, record date of last Day of Symptoms
    Descripción

    Last Day of Symptoms

    Tipo de datos

    date

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C1517741
    UMLS CUI [1,3]
    C1457887
    Symptom Causality
    Descripción

    NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event.

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C0005903
    UMLS CUI [1,2]
    C1457887
    Unsolicited Adverse Events
    Descripción

    Unsolicited Adverse Events

    Alias
    UMLS CUI-1
    C0877248
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    Descripción

    within one month (minimum 30 days)

    Tipo de datos

    text

    Alias
    UMLS CUI [1,1]
    C1519255
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0687676
    UMLS CUI [2,1]
    C1518404
    UMLS CUI [2,2]
    C0042196
    UMLS CUI [2,3]
    C0687676
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    Similar models

    Solicited and unsolicited adverse events

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    Alias
    Item Group
    Administrative data
    C1320722 (UMLS CUI-1)
    Clinical Trial Subject Unique Identifier
    Item
    Subject Identifier
    integer
    C2348585 (UMLS CUI [1])
    Item
    Cohort
    integer
    C0599755 (UMLS CUI [1])
    Cohort
    Code List
    Cohort
    CL Item
    HIV-pos. (1)
    CL Item
    HIV-neg. exposed (2)
    CL Item
    HIV-neg. unexposed, 3+1 schedule (3)
    CL Item
    HIV-neg. unexposed, 3+0 schedule (4)
    CL Item
    HIV-neg. unexposed, 2+1 schedule (5)
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Dose preceding assessment
    integer
    C3174092 (UMLS CUI [1,1])
    C0332152 (UMLS CUI [1,2])
    C0220825 (UMLS CUI [1,3])
    Dose
    Code List
    Dose preceding assessment
    CL Item
    Dose 1 (1)
    CL Item
    Dose 2 (2)
    CL Item
    Dose 3 (3)
    CL Item
    Booster Dose of 10Pn-PD-DiT (4)
    CL Item
    Booster Dose of DTPw-HBV/Hib (5)
    Item Group
    Solicited Adverse Events - Local Symptoms
    C0877248 (UMLS CUI-1)
    C1457887 (UMLS CUI-2)
    C0205276 (UMLS CUI-3)
    Item
    Select vaccination
    integer
    C0042196 (UMLS CUI [1])
    Select vaccination
    Code List
    Select vaccination
    CL Item
    10Pn-PD-DiT Vaccine (1)
    CL Item
    DTPw-HBV/Hib Vaccine (2)
    Item
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    text
    C0037088 (UMLS CUI [1,1])
    C2700396 (UMLS CUI [1,2])
    C0347984 (UMLS CUI [1,3])
    C1948053 (UMLS CUI [1,4])
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    Code List
    Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
    CL Item
    Information not available  (U)
    CL Item
    No Vaccine administered  (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items (Y)
    Item
    Select symptom
    integer
    C1457887 (UMLS CUI [1])
    Select vaccination
    Code List
    Select symptom
    CL Item
    Redness (1)
    CL Item
    Swelling (2)
    CL Item
    Pain (3)
    Presence of Symptom
    Item
    Presence of Symptom
    boolean
    C1457887 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    Size Day 0
    Item
    Size Day 0
    integer
    C0456389 (UMLS CUI [1])
    Size Day 1
    Item
    Size Day 1
    integer
    C0456389 (UMLS CUI [1])
    Size Day 2
    Item
    Size Day 2
    integer
    C0456389 (UMLS CUI [1])
    Size Day 3
    Item
    Size Day 3
    integer
    C0456389 (UMLS CUI [1])
    Item
    Pain intensity Day 0
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 0
    Code List
    Pain intensity Day 0
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    CL Item
    Absent (0)
    Item
    Pain intensity Day 1
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 0
    Code List
    Pain intensity Day 1
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    CL Item
    Absent (0)
    Item
    Pain intensity Day 2
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 0
    Code List
    Pain intensity Day 2
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    CL Item
    Absent (0)
    Item
    Pain intensity Day 3
    integer
    C1320357 (UMLS CUI [1])
    Pain intensity Day 0
    Code List
    Pain intensity Day 3
    CL Item
    Minor reaction to touch (1)
    CL Item
    Cries / protests on touch (2)
    CL Item
    Cries when limb is moved / spontaneously painful (3)
    CL Item
    Absent (0)
    Symptom ongoing after Day 3?
    Item
    Symptom ongoing after Day 3?
    boolean
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Last Day of Symptoms
    Item
    If Symptom is ongoing after Day 3, record date of last Day of Symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Item Group
    Solicited Adverse Events - General Symptoms
    C1457887 (UMLS CUI-1)
    C0042196 (UMLS CUI-2)
    C0877248 (UMLS CUI-3)
    Item
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    text
    C0877248 (UMLS CUI [1,1])
    C0347984 (UMLS CUI [1,2])
    C1948053 (UMLS CUI [1,3])
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    Code List
    Has the subject experienced any of the following signs/symptoms during the solicited period?
    CL Item
    Information not available (U)
    CL Item
    No Vaccine administered (NA)
    CL Item
    No (N)
    CL Item
    Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
    Item
    Select symptom
    integer
    C1457887 (UMLS CUI [1])
    Select vaccination
    Code List
    Select symptom
    CL Item
    Fever (1)
    CL Item
    Irritability/Fussiness (2)
    CL Item
    Drowsiness (3)
    CL Item
    Loss of appetite (4)
    CL Item
    Diarrhoea (5)
    CL Item
    Vomiting (6)
    Presence of Symptom
    Item
    Presence of Symptom
    boolean
    C1457887 (UMLS CUI [1,1])
    C0150312 (UMLS CUI [1,2])
    Item
    Fever, Site of measurement
    text
    C0449687 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Site of measurement
    Code List
    Fever, Site of measurement
    CL Item
    Axillary (A)
    CL Item
    Oral (O)
    CL Item
    Rectal (R)
    CL Item
    Tympanic (oral conversion) (X)
    CL Item
    Tympanic (rectal conversion) (Y)
    Temperature taken on Day 0?
    Item
    Temperature taken on Day 0?
    boolean
    C0886414 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Fever on Day 0
    Item
    Fever on Day 0
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Temperature taken on Day 1?
    Item
    Temperature taken on Day 1?
    boolean
    C0886414 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Fever on Day 1
    Item
    Fever on Day 1
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Temperature taken on Day 2?
    Item
    Temperature taken on Day 2?
    boolean
    C0886414 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Fever on Day 2
    Item
    Fever on Day 2
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Temperature taken on Day 3?
    Item
    Temperature taken on Day 3?
    boolean
    C0886414 (UMLS CUI [1,1])
    C0884358 (UMLS CUI [1,2])
    Fever on Day 3
    Item
    Fever on Day 3
    float
    C0005903 (UMLS CUI [1,1])
    C0015967 (UMLS CUI [1,2])
    Item
    Symptom Intensity on Day 0
    integer
    C0518690 (UMLS CUI [1])
    Pain
    Code List
    Symptom Intensity on Day 0
    CL Item
    Behavior as usual (0)
    CL Item
    Symptom easily tolerated / no effect on normal activity (1)
    CL Item
    Symptom interferes with normal activity (2)
    CL Item
    Symptom prevents normal activity (3)
    Item
    Symptom Intensity on Day 1
    integer
    C0518690 (UMLS CUI [1])
    Pain
    Code List
    Symptom Intensity on Day 1
    CL Item
    Behavior as usual (0)
    CL Item
    Symptom easily tolerated / no effect on normal activity (1)
    CL Item
    Symptom interferes with normal activity (2)
    CL Item
    Symptom prevents normal activity (3)
    Item
    Symptom Intensity on Day 2
    integer
    C0518690 (UMLS CUI [1])
    Pain
    Code List
    Symptom Intensity on Day 2
    CL Item
    Behavior as usual (0)
    CL Item
    Symptom easily tolerated / no effect on normal activity (1)
    CL Item
    Symptom interferes with normal activity (2)
    CL Item
    Symptom prevents normal activity (3)
    Item
    Symptom Intensity on Day 3
    integer
    C0518690 (UMLS CUI [1])
    Pain
    Code List
    Symptom Intensity on Day 3
    CL Item
    Behavior as usual (0)
    CL Item
    Symptom easily tolerated / no effect on normal activity (1)
    CL Item
    Symptom interferes with normal activity (2)
    CL Item
    Symptom prevents normal activity (3)
    Number of episodes on Day 0
    Item
    Number of episodes on Day 0
    integer
    C0750480 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C0439505 (UMLS CUI [1,3])
    Number of episodes on Day 1
    Item
    Number of episodes on Day 1
    integer
    C0750480 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C0439505 (UMLS CUI [1,3])
    Number of episodes on Day 2
    Item
    Number of episodes on Day 2
    integer
    C0750480 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C0439505 (UMLS CUI [1,3])
    Number of episodes on Day 3
    Item
    Number of episodes on Day 3
    integer
    C0750480 (UMLS CUI [1,1])
    C0332189 (UMLS CUI [1,2])
    C0439505 (UMLS CUI [1,3])
    Symptom ongoing after Day 3?
    Item
    Symptom ongoing after Day 3?
    boolean
    C1457887 (UMLS CUI [1,1])
    C0549178 (UMLS CUI [1,2])
    Last Day of Symptoms
    Item
    If Symptom is ongoing after Day 3, record date of last Day of Symptoms
    date
    C0011008 (UMLS CUI [1,1])
    C1517741 (UMLS CUI [1,2])
    C1457887 (UMLS CUI [1,3])
    Symptom Causality
    Item
    Symptom Causality
    boolean
    C0005903 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    Item Group
    Unsolicited Adverse Events
    C0877248 (UMLS CUI-1)
    Item
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    text
    C1519255 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0687676 (UMLS CUI [1,3])
    C1518404 (UMLS CUI [2,1])
    C0042196 (UMLS CUI [2,2])
    C0687676 (UMLS CUI [2,3])
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month post-vaccination?
    Code List
    Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
    CL Item
    Information not available  (U)
    CL Item
    No Vaccine administered  (NA)
    CL Item
    No  (N)
    CL Item
    Yes, Fill in the Non-Serious Adverse Event form or Serious Adverse Event form as necessary (Y)
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