ID
37967
Description
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 is to be used in case of a Serious Adverse Event (SAE), which is here defined as: A serious adverse event (SAE) is any untoward medical occurrence that: a. results in death, b. is life-threatening, NOTE: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe. c. requires hospitalization or prolongation of existing hospitalization, NOTE: In general, hospitalization signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician’s office or out-patient setting. Complications that occur during hospitalization are AEs. If a complication prolongs hospitalization or fulfils any other serious criteria, the event is serious. When in doubt as to whether “hospitalization” occurred or was necessary, the AE should be considered serious. Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is not considered an AE. d. results in disability/incapacity, or NOTE: The term disability means a substantial disruption of a person’s ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption. e. is a congenital anomaly/birth defect in the offspring of a study subject. f. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately lifethreatening or result in death or hospitalization but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization. Serious Adverse Events (SAEs) related to study participation (e.g. procedures, invasive tests, change from existing therapy) or SAEs related to GSK concurrent medication will be collected and recorded from the time the subject consents to participate in the study. For all other SAEs, the standard time period for collecting and recording SAEs will begin from the administration of the first dose of vaccine / placebo / comparator and will end minimum 30 days (see protocol) following administration of the last dose of vaccine / placebo / comparator for each subject.
Mots-clés
Versions (2)
- 03/09/2019 03/09/2019 -
- 17/10/2019 17/10/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
3 septembre 2019
DOI
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Licence
Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010
SAE
- StudyEvent: ODM
Description
Section 1: General SAE information
Alias
- UMLS CUI-1
- C1508263
- UMLS CUI-2
- C1519255
Description
Diagnosis only (if known), otherwise sign / symptom A separate form should be used for each SAE however if multiple SAEs which are temporarily or clinically related are apparent at the time of initial reporting then these may be reported on the same page.
Type de données
text
Alias
- UMLS CUI [1]
- C1519255
Description
The start date should document the first occurrence of the SAE. This is generally the start date of the signs/symptoms and not necessarily the date that the event met the definition of serious.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C1519255
Description
All SAEs must be followed until the events are resolved, the condition stabilises, the events are otherwise explained, or the subject is lost to follow-up. Indicate if the event was “Recovered/Resolved” or Recovered/Resolved with sequelae”. If the SAE is ongoing at the time the subject completed the study or becomes lost to follow-up, the outcome must be recorded as “Recovering/Resolving” or “Not recovered/Not resolved”. Also enter “Not recovered/Nor resolved” if the SAE was ongoing at the time of death, but was not the cause of death, enter fatal for the SAE which was direct cause of death.
Type de données
integer
Alias
- UMLS CUI [1]
- C1705586
Description
If fatal, record date of death Record the date of resolution or the date of death as applicable. Leave blank only if the outcome of the event is “Not resolved” – “ Recovering / resolving”.
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C1519255
Description
Record the maximum intensity that occurred over the duration of the event (see protocol for 1-2-3 definition of intensity). Amend the intensity if it increases. Enter X (not Applicable) if grading can not be applied. For example, intensity for ‘broken leg’.
Type de données
text
Alias
- UMLS CUI [1,1]
- C0518690
- UMLS CUI [1,2]
- C1519255
Description
If administration of the investigational product was stopped permanently and not restarted enter 1- Investigational product(s) withdrawn and enter the date that investigational product was discontinued in section 9. If administration of the investigational product was not modified and all scheduled doses were given enter 2-Dose not changed. If administration of investigational product was temporarily interrupted but then restarted enter 3- Dose Interrupted. If the subject did not receive investigational product dose at the time of the event or if the subject has received all his doses or if the subject died and there was no prior decision to discontinue investigational product enter X-Not applicable.
Type de données
text
Alias
- UMLS CUI [1,1]
- C2826626
- UMLS CUI [1,2]
- C1519255
Description
If Yes, please complete the Study Conclusion form of the subject and tick SAE as reason for withdrawal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1519255
Description
This box is mandatory and has to be completed before faxing the form. It is a regulatory requirement for investigators to assess relationship to investigational product(s) based on information available. The assessment should be reviewed on receipt of any new information and amended if necessary. ’A reasonable possibility’ is meant to convey that there are facts/evidence or arguments to suggest a causal relationship. Facts/evidence or arguments that may support ’a reasonable possibility’ include, e.g., a temporal relationship, a pharmacologicallypredicted event, or positive dechallenge or rechallenge. Confounding factors, such as concomitant medication, a concurrent illness, or relevant medical history, should also be considered.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0085978
Description
Refer to protocol for full definition
Type de données
text
Alias
- UMLS CUI [1,1]
- C0545082
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C1519255
Description
If Yes, summarise findings in Section 11 Narrative Remarks of this SAE form.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0004398
- UMLS CUI [1,2]
- C0011065
- UMLS CUI [1,3]
- C1519255
Description
Section 2: Seriousness
Alias
- UMLS CUI-1
- C1710056
Description
In the event of a death determined by the investigator to be related to the vaccination, sending of the fax must be accompanied by phone call to the study contact for reporting SAEs.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0011065
- UMLS CUI [1,2]
- C1519255
Description
Note: The term 'life-threatening' in the definition of 'serious' refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe.
Type de données
boolean
Alias
- UMLS CUI [1]
- C1517874
Description
Note: In general, hospitalisation signifies that the subject has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Complications that occur during hospitalisation are AEs. If a complication prolongs hospitalisation or fulfils any other serious criteria, the event is 'serious'. When in doubt as to whether 'hospitalisation' occurred or was necessary, the AE should be considered 'serious'. Hospitalisation for elective treatment of a preexisting condition that did not worsen from baseline is not considered an AE. Record date of admission and discharge Requires hospitalisation or prolongation of existing hospitalisation The following cases are not defined as serious AEs and no SAE report is no to be submitted : · Hospitalization for elective surgery related to a pre-existing condition which did not increase in severity or frequency following initiation of the study (e.g. : aesthetic surgery or surgery planned before subject enrolled), · Hospitalisation for routine clinical procedure or for social reason (e.g. : elderly person had an extension of hospitalization because of room is available in a resting home) that are not the result of an adverse event These latter cases have to be recorded in the CRF only. If the hospitalization arises from a preexisting condition or was planned prior to the first vaccination, it should be recorded in the Medical History section of the CRF. If the hospitalisation was planned after the first vaccination, it should be recorded in the AE pages. In both cases, it should be recorded as “Hospitalisation” (not an adverse event) or “Hospitalisation for social reason” (not an adverse event) or “Elective surgery” (not an adverse event) and the relationship to vaccination will be checked “No”.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0019993
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2,1]
- C0745041
- UMLS CUI [2,2]
- C1519255
Description
Note: The term disability means a substantial disruption of a person's ability to conduct normal life functions. This definition is not intended to include experiences of relatively minor medical significance such as uncomplicated headache, nausea, vomiting, diarrhoea, influenza, and accidental trauma (e.g. , sprained ankle) which may interfere or prevent everyday life functions but do not constitute a substantial disruption.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0231170
Description
Congenital anomaly/birth defect in the offspring
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0000768
- UMLS CUI [1,2]
- C1519255
Description
Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious. Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse.
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
Description
Other SAE seriousness specification
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1710056
- UMLS CUI [1,3]
- C1521902
Description
if hospitalisation is reason of why AE is serious
Type de données
date
Alias
- UMLS CUI [1]
- C0806429
Description
if hospitalisation is reason of why AE is serious
Type de données
date
Alias
- UMLS CUI [1]
- C2361123
Description
Section 3: Demography Data
Alias
- UMLS CUI-1
- C0011298
Description
Date of birth
Type de données
date
Alias
- UMLS CUI [1]
- C0421451
Description
Sex
Type de données
text
Alias
- UMLS CUI [1]
- C0079399
Description
Weight
Type de données
float
Unités de mesure
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
(US only; give ounces in next item)
Type de données
integer
Unités de mesure
- pounds
Alias
- UMLS CUI [1]
- C0005910
Description
(US only; give pounds in next item)
Type de données
integer
Unités de mesure
- ounces
Alias
- UMLS CUI [1]
- C0005910
Description
Section 4: SAE reccurence
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0034897
Description
If deliberate or inadvertent administration of further dose(s) of investigational product(s) to the subject occurred, did the reported adverse event recur?
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0034897
- UMLS CUI [1,3]
- C0304229
Description
Section: 5 Possible Causes of SAE Other Than Investigational Product(s)
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205394
- UMLS CUI-3
- C0085978
- UMLS CUI-4
- C0304229
Description
(not applicable for prophylactic vaccine studies)
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C0008976
Description
(record in Section 6)
Type de données
boolean
Alias
- UMLS CUI [1]
- C0009488
Description
Lack of efficacy
Type de données
boolean
Alias
- UMLS CUI [1]
- C0235828
Description
Withdrawal of investigational product
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C2349954
- UMLS CUI [1,2]
- C0304229
Description
Concomitant medication(s)
Type de données
boolean
Alias
- UMLS CUI [1]
- C2347852
Description
(e.g., procedures)
Type de données
boolean
Alias
- UMLS CUI [1]
- C2348568
Description
please specify in next item
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0085978
Description
Specify other SAE causation
Type de données
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1521902
Description
Section 6: Relevant Medical Conditions
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0262926
- UMLS CUI-3
- C1519255
Description
Relevant Medical Conditions
Type de données
text
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C1519255
- UMLS CUI [2]
- C0012634
- UMLS CUI [3]
- C0020517
- UMLS CUI [4]
- C0543467
Description
Date of onset
Type de données
date
Alias
- UMLS CUI [1,1]
- C0574845
- UMLS CUI [1,2]
- C0012634
Description
If no, record date of last occurrence
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0347984
- UMLS CUI [1,3]
- C1519255
Description
Date of Last Occurrence
Type de données
date
Alias
- UMLS CUI [1,1]
- C1517741
- UMLS CUI [1,2]
- C2745955
- UMLS CUI [1,3]
- C0012634
- UMLS CUI [1,4]
- C0011008
Description
Section 7: Other Relevant Risk Factors
Alias
- UMLS CUI-1
- C0205394
- UMLS CUI-2
- C0035648
- UMLS CUI-3
- C1519255
Description
Section 8: Relevant Concomitant Medications
Alias
- UMLS CUI-1
- C2347852
Description
(Trade name preferred)
Type de données
text
Alias
- UMLS CUI [1]
- C2347852
Description
Concomitant Medication Dose
Type de données
integer
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Unit
Type de données
text
Alias
- UMLS CUI [1,1]
- C1519795
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Frequency
Type de données
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Route
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Taken Prior to Study?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826667
Description
Concomitant Medication Start Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
Description
Concomitant Medication Stop Date
Type de données
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
Description
Ongoing Concomitant Medication ?
Type de données
boolean
Alias
- UMLS CUI [1]
- C2826666
Description
Reason for Concomitant Medication
Type de données
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C2347852
Description
Section 9: Details of investigational product(s)
Alias
- UMLS CUI-1
- C0013230
- UMLS CUI-2
- C1522508
Description
in case of multiple vaccination, please specify if vaccines were administered mixed or separately
Type de données
text
Alias
- UMLS CUI [1]
- C0042210
Description
Dose number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1115464
- UMLS CUI [1,2]
- C0042210
Description
Lot number
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1115660
- UMLS CUI [1,2]
- C0042210
Description
Route / site
Type de données
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [2,1]
- C1515974
- UMLS CUI [2,2]
- C0042210
Description
Administration date
Type de données
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0042210
Description
Randomization code broken
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C3897431
Description
Section 10: Details of Relevant Assessments
Alias
- UMLS CUI-1
- C1261322
- UMLS CUI-2
- C1519255
Description
Section 11: Narrative Remarks
Alias
- UMLS CUI-1
- C0947611
Description
Section 12: SAE additional / follow-up information
Alias
- UMLS CUI-1
- C1524062
- UMLS CUI-2
- C1533716
- UMLS CUI-3
- C1519255
- UMLS CUI-4
- C1522577
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's signature
Type de données
text
Alias
- UMLS CUI [1]
- C2346576
Description
Printed Investigator's name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Type of report
Type de données
integer
Alias
- UMLS CUI [1]
- C0585733
Description
Date of investigator's signature
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
SAE
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0684224 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C2347796 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C0011065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0745041 (UMLS CUI [2,1])
C1519255 (UMLS CUI [2,2])
C0231170 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1710056 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0034897 (UMLS CUI-2)
C0034897 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
C0304229 (UMLS CUI-4)
C0347984 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,4])
C0262926 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2])
C0020517 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
C0012634 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C2745955 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,4])
C0035648 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1519255 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C2347852 (UMLS CUI [1,2])
C1522508 (UMLS CUI-2)
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C3897431 (UMLS CUI [1,2])
C1519255 (UMLS CUI-2)
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C1522577 (UMLS CUI-4)
C1533716 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C1522577 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])