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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 1 NCT00317161 - Visit 1 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

- 21-06-17 - 1 Formulier, 14 Itemgroepen, 233 Data-elementen, 1 Taal

Itemgroepen: Informed Consent, Demographics, Eligibility Question, Randomisation, General Medical History / Physical Examination, Laboratory Tests, Protocol required Concomitant Vaccination, Vaccine Administration, Single Injection, Vaccine Administration, Multi Injections, Solicited Adverse Events - Local Symptoms - Booster Dose, Solicited Adverse Events - Local Symptoms - DTPw-HBV/Hib vaccine, Solicited Adverse Events - Local Symptoms - Meningitec vaccine, Solicited Adverse Events - General Symptoms, Unsolicited Adverse Events

Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 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 Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 1: 15-24 months of age

Concomitant Vaccination: GSK DTPa vaccine (Infanrix) 100484 - Study ID: 100484 Concomitant Vaccination

- 19-06-17 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal

Itemgroep: Concomitant Vaccination

Study ID: 100484 Clinical Study ID: 100484 (DTPa) Study Title: An open prospective study of immunogenicity and reactogenicity of DTPa vaccine (Infanrix) given as a booster to healthy school children 10 to 12 years of age Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Diphtheria, Tetanus, Acellular Pertussis Vaccine Adsorbed Trade Name: BIO DTPA (INFANRIX); Infanrix Study Indication: Acellular Pertussis; Diphtheria; Tetanus; acellular pertussis Documentation: Concomitant Vaccination

Sentinel Common Data Model Vaccination Status

- 29-01-17 - 1 Formulier, 1 Itemgroep, 10 Data-elementen, 1 Taal

Itemgroep: Vaccination Status

Sentinel: Overview and Description of the Common Data Model v6.0 "The primary goal of the Sentinel pilot is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data. This data model is freely available to all. For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM State Vaccine Table contains vaccination records received from Immunization Information Systems for patients identified and matched from selected Data Partners. It contains one record per vaccination, per unique PatID, VaxDate, VaxCode, Provider and AdminType. The V_EncounterID serves as the unique identifier for each record.

Eligibility Mantle Cell Lymphoma NCT00005780

- 24-01-16 - 1 Formulier, 2 Itemgroepen, 13 Data-elementen, 1 Taal

Itemgroepen: Criteria, Exclusion Criteria

Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00005780

Eligibility Leukemia,Myeloid, Chronic NCT00027144

- 19-01-16 - 1 Formulier, 2 Itemgroepen, 18 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion criteria

Study Using Vaccination With Heat Shock Protein 70 (HSP70) for the Treatment of CML in Chronic Phase; ODM derived from: https://clinicaltrials.gov/show/NCT00027144

Vaccine Administration Form (NCT00513526)

- 16-01-15 - 1 Formulier, 1 Itemgroep, 7 Data-elementen, 2 Talen

Itemgroep: Vaccine Module

AMC-052 Vaccine Administration Form Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection NCT00513526 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=39520C70-99B3-4542-E044-0003BA3F9857

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