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Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Long-Term Follow-Up (Month 60) - Demographics; Laboratory Tests; Follow-Up Studies; Safety Follow-Up - Serious Adverse Events; Tracking Document

- 2019-03-18 - 1 Formulär, 15 Item-grupper, 76 Dataelement, 1 Språk
Item-grupper: Administrative, Demographics, Laboratory Tests, Follow-Up Studies, Investigator Signature, Serious Adverse Events, SAE - Study Vaccine Information (13), SAE - Concomitant medication / vaccination that could have contributed to this SAE (14), SAE - Relevant intercurrent illness & medical history that could have contributed to this SAE (15), Drug(s) used to treat this SAE (16), Surgical treatment for this SAE (17), Description (18), SAE - Comments, Tracking Document, Investigator signature
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021 - Non-Serious Adverse Events Form

- 2018-11-30 - 1 Formulär, 3 Item-grupper, 13 Dataelement, 1 Språk
Item-grupper: Administrative data, Non-Serious Adverse Events, Non-Serious Adverse Events Data
Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Concomitant Vaccination, Concomitant Medication, Non-Serious Adverse Events, Study Conclusion Forms

- 2019-01-09 - 1 Formulär, 8 Item-grupper, 46 Dataelement, 1 Språk
Item-grupper: Administrative data, Concomitant Vaccination, Vaccination details, Concomitant Medication, Concomitant Medication Details, Non-Serious Adverse Events, Description of Event, Study Conclusion
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

Immunogenicity, safety and reactogenicity of combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) in healthy children (100565) - Concomitant Vaccination; Medication; Non-Serious Adverse Experiences; Serious Adverse Experiences; Study Conclusion;

- 2019-04-10 - 1 Formulär, 8 Item-grupper, 60 Dataelement, 1 Språk
Item-grupper: Administrative, Concomitant Vaccination, Medication, Non-Serious Adverse Experiences, Serious Adverse Experiences, Serious Adverse Experiences - Relevant Laboratory Data, Serious Adverse Experiences - Relevant Laboratory Data , Study Conclusion
Study ID: 100565 Clinical Study ID: 100565 Study Title: An open study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals' commercially available combined hepatitis A / hepatitis B vaccine (TWINRIX ADULT) containing 720 ELISA units of hepatitis A antigen and 20 µg of hepatitis B surface antigen, administered following a two-dose (0, 6 months) schedule in healthy children between the ages of 1 and 11 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056 - Visit 5

- 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
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

Infanrix Vaccine - 102038 - Solicited Adverse Events

- 2018-03-04 - 1 Formulär, 6 Item-grupper, 21 Dataelement, 1 Språk
Item-grupper: Solicited Adverse Events Local Symptoms, Local Symptoms, Daily Record of Symptom Severeness, Solicited Adverse Events General Symptoms, General Symptoms, Daily Record of Symptom Severeness
Open, phase IV clinical trial to compare the immunogenicity and reactogenicity of GSK Biologicals’ Infanrix™ (DTPa) vaccine administered as a booster dose at 4 years of age in preterm vs. full-term children previously primed and boosted with Infanrix™ hexa.

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 8, Day 74, Vaccination 6, Adverse Events

- 2018-04-18 - 1 Formulär, 6 Item-grupper, 52 Dataelement, 1 Språk
Item-grupper: Check for study continuation , Laboratory tests, Blood film for parasitemia determination, Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 8, Day 74, Vaccination 6, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 7, Day 60, Vaccination 5, Adverse Events

- 2018-04-18 - 1 Formulär, 6 Item-grupper, 53 Dataelement, 1 Språk
Item-grupper: Check for study continuation , Clearance of Malaria parasitemia, Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 7, Day 60, Vaccination 5, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 5, Day 30, Vaccination 3, Adverse Events

- 2018-04-18 - 1 Formulär, 5 Item-grupper, 49 Dataelement, 1 Språk
Item-grupper: Check for study continuation , Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 5, Day 30, Vaccination 3, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 6, Day 44, Vaccination 4, Adverse Events

- 2018-04-18 - 1 Formulär, 5 Item-grupper, 49 Dataelement, 1 Språk
Item-grupper: Check for study continuation , Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 6, Day 44, Vaccination 4, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 3, Vaccination 2, Adverse Events

- 2018-04-18 - 1 Formulär, 5 Item-grupper, 47 Dataelement, 1 Språk
Item-grupper: Check for study continuation , Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 3, Vaccination 2, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region, Study ID: 103967, NCT00197028 - Visit 2, Vaccination 1, Adverse Events

- 2018-04-18 - 1 Formulär, 4 Item-grupper, 44 Dataelement, 1 Språk
Item-grupper: Vaccine Administration, Unsolicited adverse events, Solicited adverse events - Local symptoms, Solicited adverse events - General symptoms
https://clinicaltrials.gov/show/NCT00197028 Visit 2, Vaccination 1, Adverse Events Study ID: 103967 Clinical Study ID: 103967 Study Title: A Phase I/IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine in infants living in a malaria-endemic region Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00197028 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB257049 Trade Name: BIO MALARIA; SB257049 Study Indication: Malaria

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