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Eligibility Oral Mucositis NCT01265810

- 1/21/21 - 1 form, 2 itemgroups, 15 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes which include oral intake, swallowing function and pain associated with incidence of grade ≥ 1 oral side effects and the anticancer therapy cessation in patients treated with selected targeted anticancer therapy.

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

- 3/11/19 - 1 form, 29 itemgroups, 196 items, 1 language
Itemgroups: 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

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

- 1/11/19 - 1 form, 23 itemgroups, 137 items, 1 language
Itemgroups: 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

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Visit 3: Vaccine Administration, Eligibility Criteria, Symptoms, Adverse Events Forms

- 1/9/19 - 1 form, 11 itemgroups, 74 items, 1 language
Itemgroups: Administrative data, Check for Study Continuation, Elimination Criteria During The Study, Vaccine Administration - Vaccine 1, Vaccine Administration - 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

Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974 - Visit 1: Eligibility Criteria, Consent Form

- 1/9/19 - 1 form, 23 itemgroups, 137 items, 1 language
Itemgroups: 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

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