Geselecteerde datamodellen

U moet ingelogd zijn om meerdere datamodellen te selecteren en die te downloaden of te analyseren.

14 Zoekresultaten.
Relevantie Beoordeling Nieuwe eerst Oude eerst

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 2 (Amendment, Month 1.5 42 – 62 days after birth) Dose 1

- 28-02-19 - 1 Formulier, 17 Itemgroepen, 203 Data-elementen, 1 Taal
Itemgroepen: 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 4 (Amendment, Month 3.5 28 – 42 days after Visit 3) Dose 3

- 28-02-19 - 1 Formulier, 14 Itemgroepen, 166 Data-elementen, 1 Taal
Itemgroepen: Administrative data, CHECK FOR STUDY CONTINUATION, 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 5 (Amendment, Month 4.5 30 – 42 days after Visit 4) + Study Conclusion

- 28-02-19 - 1 Formulier, 12 Itemgroepen, 48 Data-elementen, 1 Taal
Itemgroepen: Administrative data, CHECK FOR STUDY CONTINUATION, LABORATORY TESTS (GROUPS DTPW-HBV Kft + Hiberix™), LABORATORY TESTS (OTHERS GROUPS), CONCOMITANT VACCINATION, MEDICATION, NON-SERIOUS ADVERSE EVENTS, STUDY CONCLUSION, OCCURRENCE OF SERIOUS ADVERSE EVENT, ELIMINATION CRITERIA, WITHDRAWAL FROM STUDY, INVESTIGATOR'S SIGNATURE
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 3 (Amendment, Month 2.5 28 – 42 days after Visit 2) Dose 2

- 28-02-19 - 1 Formulier, 14 Itemgroepen, 166 Data-elementen, 1 Taal
Itemgroepen: Administrative data, CHECK FOR STUDY CONTINUATION, 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 3 (Month 2.5 28 – 42 days after Visit 2)

- 28-02-19 - 1 Formulier, 17 Itemgroepen, 199 Data-elementen, 1 Taal
Itemgroepen: 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants 101222 - Visit 2 (Month 1.5 42 – 62 days after birth)

- 28-02-19 - 1 Formulier, 17 Itemgroepen, 199 Data-elementen, 1 Taal
Itemgroepen: 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 4 (Month 3.5 28 – 42 days after Visit 3)

- 28-02-19 - 1 Formulier, 17 Itemgroepen, 199 Data-elementen, 1 Taal
Itemgroepen: 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
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - VISIT 1 (Day 0 Birth)

- 28-02-19 - 1 Formulier, 10 Itemgroepen, 51 Data-elementen, 1 Taal
Itemgroepen: ELIMINATION CRITERIA DURING THE STUDY, CONTRAINDICATIONS TO SUBSEQUENT VACCINATION, PRECAUTIONS, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, RANDOMISATION / TREATMENT ALLOCATION, GROUP HBV AT BIRTH
Study ID: 101222 Clinical Study ID: 101222 Study Title: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name:Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 4: Non-Serious Adverse Events Form

- 10-12-18 - 1 Formulier, 3 Itemgroepen, 14 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Non-Serious Adverse Events, Non-Serious Adverse Events Data
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: Solicited Adverse Events

- 05-12-18 - 1 Formulier, 5 Itemgroepen, 25 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Solicited Adverse Events, Local Symptoms - Redness, Local Symptoms - Swelling, Local Symptoms - Pain
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: Solicited Adverse Events - General Symptoms

- 05-12-18 - 1 Formulier, 7 Itemgroepen, 38 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Solicited Adverse Events, Fever, Irritability/Fussiness, Drowsiness, Loss of Appetite, In case of "Severe" Intensity of Crying:
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065 - Visit 1: General Medical History

- 05-12-18 - 1 Formulier, 16 Itemgroepen, 30 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Physical Examination, Cutaneous, Eyes, Ears-Nose-Throat, Cardiovascular, Respiratory, Gastrointestinal, Muskuloskeletal, Neurological, Genitourinary, Haematology, Allergies, Endocrine, Persistent crying, Other, specify
Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial