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Ministry of Health, Ethiopia- HIV–Exposed Infant Follow up Card - HIV–Exposed Infant Follow up Card

- 05.07.16 - 1 Formular, 2 Itemgruppen, 52 Datenelemente, 1 Sprache
Itemgruppen: Demographics, Follow up chart
Form provided by Binyam Tilahun. Source: http://www.moh.gov.et/ (Ministry of Health, Ethiopia)

Ministry of Health, Ethiopia- HMIS HIV exposed infant logbook card - HIV exposed infant logbook card

- 06.07.16 - 1 Formular, 1 Itemgruppe, 27 Datenelemente, 1 Sprache
Itemgruppe: Logbook card
Form provided by Binyam Tilahun. Source: http://www.moh.gov.et/ (Ministry of Health, Ethiopia)

HICDEP - Basic follow-up/visit related data (tblVIS)

- 29.01.18 - 26 Formulare, 4 Itemgruppen, 19 Datenelemente, 1 Sprache
Itemgruppen: Basic follow-up/visit related data, Additional questions for adolescents and adults, Additional questions for children and infants, Additional questions for infants
HICDEP stands for HIV Cohorts Data Exchange Protocol. The HIV Cohorts Data Exchange Protocol (HICDEP) is a protocol that allows for simple sharing of data from HIV cohorts by providing a standard format for datasets. It is used by several major HIV Cohort Collaborations such as CASCADE, COHERE, EuroSIDA, PENTA, EPPICC ART-CC and D:A:D. Its first version was presented at the 7th International Workshop on HIV Observational Databases in March 29–30, 2003, Fiuggi, Italy, and a summary was published in Antiviral Therapy. The specification currently consists of 27 tables in a relational structure which cover most medical aspects of HIV patient histories used in clinical research, including pediatric aspects. Subform Descriptions: -tblCEP - Clinical Events and Procedures: holds type and date of adverse events including serious non-AIDS conditions -tblART- Antiretroviral treatment: holds type of antiretroviral drug, start and stop dates and reason for stopping -tblBAS - Basic clinical, background and demographic information: holds basic information such as demographics, basic clinical information, date of AIDS diagnosis, death and drop-out information -tblDELIVERY_CHILD - Delivery information related to the child(ren): This table holds information about a delivery specific to a child. Mother-specific data is kept in tblDELIVERY_MUM. -tblDELIVERY_MUM - Delivery information related to the mother: This table contains information about the delivery specific to the mother. Child-specific information is recorded in tblDELIVERY_CHILD instead. -tblDIS - Opportunistic infections: holds type and date of CDC-C diseases. -tblLAB - Laboratory values: holds type, date, value and unit of laboratory tests -tblLAB_BP - Laboratory values - Blood pressure: holds date, diastolic and systolic values and unit of blood pressure measurements. -tblLAB_CD4 - Laboratory values: holds date and value of CD4 measurements. -tblLAB_RNA - Laboratory values: holds date, value, detection limit and type of viral assay. -tblLAB_RES - Resistance testing: holds background information on the resistance test, laboratory, library, kit, software and type of test -tblLAB_RES_LVL_1 - Nucleotide sequences (PRO, RT, GP41, GP120): holds nucleoside sequence for the PRO and RT sequences. No entry is made if the test was a phenotype test. -tblLAB_RES_LVL_2 - Mutations: holds mutations and positions of PRO and RT sequences. -tblLAB_RES_LVL_3 - Resistance test result: holds resistance result in relation to antiretroviral drug. tblLAB_VIRO - Laboratory values - viro-/serology: holds test results for viro-/serological tests (hepatitis etc.) -tblLTFU - Death and drop-out: holds data in death and drop-out -tblMED - Other medication: holds type, start and stop dates for other medication/treatments. -tblNEWBORN - Newborn: holds information related to newborns -tblNEWBORN_ABNORM - Abnormalities: Abnormalities in newborns are recorded here, one abnormality per row. The absence of a record is to be interpreted as "unknown whether the abnormality existed" since most cohorts only record positive events. -tblOVERLAP - Cross-cohort identification: holds information on the patient's participation in other cohorts -tblPREG - Pregnancy: holds general pregnancy-related information -tblPREG_OBS - Obstetrical problems during pregnancy: This table describes problems during a pregnancy. Abnormalities in newborns are recorded in tblNEWBORN_ABNORM instead. -tblPREG_OUT - Pregnancy outcome: This table describes outcomes of pregnancies described in tblPREG. -tblREFILL - Prescription refill data: holds drug, refill date and supply of prescriptions -tblSAMPLES - Blood Samples: This table contains information on the storage of blood, urine and other samples stored in a laboratory. -tblVIS - Basic follow-up/visit related data: holds visit related information such as weight, wasting, smoking, occupational status etc.

Obstetrical problems during pregnancy (tblPREG_OBS)

1 Itemgruppe 5 Datenelemente

Abnormalities (tblNEWBORN_ABNORM)

1 Itemgruppe 3 Datenelemente

Laboratory values - viro-/serology (tblLAB_VIRO)

1 Itemgruppe 9 Datenelemente

Cross-cohort identification (tblOVERLAP)

1 Itemgruppe 4 Datenelemente

Prescription refill data (tblREFILL)

1 Itemgruppe 4 Datenelemente

Pregnancy outcome (tblPREG_OUT)

1 Itemgruppe 8 Datenelemente

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Repeat Test

- 09.01.19 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV repeat test
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Confirmation Testing

- 01.11.18 - 1 Formular, 2 Itemgruppen, 5 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV Confirmatory Test
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about the confirmation testing of the subject for HIV. It should be checked at Visit 4 and is part of study amendment 1.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644 - HIV Testing

- 01.11.18 - 1 Formular, 2 Itemgruppen, 9 Datenelemente, 1 Sprache
Itemgruppen: Administrative Data, HIV Testing
Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form contains information about testing the subject for HIV. It should be checked at Visit 3 and is part of study amendment 1.

10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010 - Study Continuation, Elimination Criteria, ICF Amendment, Weight, Meningitis, Breastfeeding Continuation

- 17.10.19 - 1 Formular, 7 Itemgruppen, 23 Datenelemente, 1 Sprache
Itemgruppen: Administrative documentation, Study Continuation, Elimination Criteria during Study, Informed Consent Amendment 1 / 2, Weight, Meningitis, Breastfeeding
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 the Study Continuation Check and (if applicable) information on why the subject was withdrawn from the study, the Elimination Criteria Check, information on whether the ICF Amendment has been signed, the subject's weight, and whether the child experienced a meningitis, and is to be filled in at Visits 2 to 10, for all cohorts. Additionally, this form records whether the infant is still breastfed, which is only applicable to HIV-negative subjects with HIV-positive mothers (=HIV-exposed cohort).

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