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Immunogenicity and safety of Fluarix / Influsplit in young adults and elderly - 111631 - Visit "Day 0" Vaccination

- 11-03-19 - 1 Formulier, 29 Itemgroepen, 196 Data-elementen, 1 Taal
Itemgroepen: 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
Study ID: 111631 Clinical Study ID: 111631 Study Title: A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2008/2009 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00706563 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Influenza vaccine Trade Name: Fluarix Study Indication: Influenza

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 5 (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 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 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

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 1

- 28-02-19 - 1 Formulier, 11 Itemgroepen, 39 Data-elementen, 1 Taal
Itemgroepen: Administrative data, ELIMINATION CRITERIA, 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

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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Reason for non participation - Tracking Form + Use of Samples Compliance

- 23-01-19 - 1 Formulier, 4 Itemgroepen, 19 Data-elementen, 1 Taal
Itemgroepen: Administrative data, Tracking Document, Use of Human Samples by GSK, Investigator's Signature
Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

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