- 2019-03-11 - 1 Formulär, 29 Item-grupper, 196 Dataelement, 1 Språk
Item-grupper: Administrative data, ELIMINATION CRITERIA, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, TREATMENT ALLOCATION, GENERAL MEDICAL HISTORY / PHYSICAL EXAMINATION, HISTORY OF INFLUENZA VACCINATION, LABORATORY TESTS, HCG URINE PREGNANCY TEST, VACCINE ADMINISTRATION, VACCINE NON-ADMINISTRATION, SOLICITED ADVERSE EVENTS - LOCAL SYMPTOMS, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Induration, Local Symptoms - Ecchymosis, Local Symptoms - Pain, SOLICITED ADVERSE EVENTS - GENERAL SYMPTOMS, General Symptoms - Temperature, General Symptoms - Fatigue, General Symptoms - Headache, General Symptoms - Myalgia, General Symptoms - Shivering, General Symptoms - Arthralgia, General Symptoms - Sweating increase, UNSOLICITED ADVERSE EVENTS
- 2019-02-28 - 1 Formulär, 17 Item-grupper, 203 Dataelement, 1 Språk
Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2019-02-28 - 1 Formulär, 17 Item-grupper, 199 Dataelement, 1 Språk
Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2019-02-28 - 1 Formulär, 17 Item-grupper, 199 Dataelement, 1 Språk
Item-grupper: Administrative data, CHECK FOR STUDY CONTINUATION, GENERAL MEDICAL HISTORY, PHYSICAL EXAMINATION, LABORATORY TESTS, VACCINE ADMINISTRATION, VACCINE ADMINISTRATION 2, VACCINE ADMINISTRATION 3, VACCINE NON-ADMINISTRATION, ADVERSE EVENTS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS, LOCAL SYMPTOMS, SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS (vaccine specific), DTPw-HBV Kft. vaccine, Hiberix™ vaccine, SOLICITED ADVERSE EVENTS – GENERAL SYMPTOMS, GENERAL SYMPTOMS
- 2019-01-22 - 1 Formulär, 12 Item-grupper, 157 Dataelement, 1 Språk
Item-grupper: General medical history/ Physical examination, Diagnosis, Baseline Measurement of mid left thigh circumference, Protocol required concomitant vaccination, Vaccine administration - Single Injection, Vaccine Administration - Multi Injection, Unsolicited Adverse events, Solicited Adverse Events - Local Symptoms, Solicited adverse events - DTPw-HBV/Hib vaccine, Solicited adverse events - Meningitec vaccine, Soliced Adverse Events - General Symptoms, Unsolicited Adverse events
- 2019-01-11 - 1 Formulär, 23 Item-grupper, 137 Dataelement, 1 Språk
Item-grupper: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms
- 2019-01-09 - 1 Formulär, 23 Item-grupper, 137 Dataelement, 1 Språk
Item-grupper: Administrative data, Elimination Criteria During The Study, Contraindications To Subsequent Vaccination, Absolute Contraindications for InfanrixTM-IPV and Aventis PediacelTM Combination Vaccines, Precautions for Vaccination, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, Randomisation / Treatment Allocation, Physical Examination, Vaccine History, Laboratory Tests - Blood, Vaccine Administration, Vaccine, Vaccine 2, Non-administration, Unsolicited Adverse Events, Solicited Adverse Events - Local Symptoms, Solicited Adverse Events - Local Symptoms - Vaccine 2, Solicited Adverse Events, General Symptoms

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