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Eligibility Determination ×
Haemophilus influenzae type b ×
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  1. 1. Clinical Trial
  2. 2. Routine Documentation
  3. 3. Registry/Cohort Study
  4. 4. Quality Assurance
  5. 5. Data Standard
  6. 6. Patient-Reported Outcome
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27 Search results.

Hib-MenAC vaccine administered intramuscularly in infants at 6 10 and 14 weeks of age - 104430 - Visit 5 ( Month 7.5)

- 12/31/19 - 1 form, 8 itemgroups, 30 items, 1 language
Itemgroups: Administrative data, ELIMINATION CRITERIA DURING THE STUDY, Contraindications and precautions for further doses, DEMOGRAPHICS, PRE-VACCINATION ASSESSMENT, THROAT SWAB (for subject’s parents/guardians), THROAT SWAB (for subject), VACCINE ADMINISTRATION
Study ID: 104430 Clinical Study ID: 104430 Study Title: A phase II, double blind, randomized, controlled study to evaluate the immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Hib-MenAC vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, as compared to GSK Biologicals’ Hiberix vaccine, extemporaneously mixed with GSK Biologicals’ Tritanrix-HepB, when administered intramuscularly in infants at 6, 10 and 14 weeks of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1/2 Study Recruitment Status: Completed Generic Name: Hib-MenAC vaccine Trade Name: Tritanrix-HepB, Hiberix Study Indication: Immune, Inflammatory & Infections - Other

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Eligibility

- 6/21/19 - 1 form, 2 itemgroups, 26 items, 1 language
Itemgroups: Exclusion Criteria, During, Clinical Trials, Vaccination, Medical contraindications
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719) - Eligibility

- 5/28/19 - 1 form, 2 itemgroups, 21 items, 1 language
Itemgroups: Exclusion Criteria, During, Clinical Trials, Vaccination, Medical contraindications
Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Immunogenicity of TPw-HBV/Hib Kft. Vaccine in healthy infants - 101222 - Visit 1

- 2/28/19 - 1 form, 11 itemgroups, 39 items, 1 language
Itemgroups: 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 1 (Day 0 Birth)

- 2/28/19 - 1 form, 10 itemgroups, 51 items, 1 language
Itemgroups: 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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 3

- 1/23/19 - 1 form, 14 itemgroups, 93 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 1: Eligibility Criteria, Physical Examination, Vaccination, Non Participation, Use of Human Samples Consent

- 1/14/19 - 1 form, 18 itemgroups, 112 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation, Reason for non participation, Investigator's Data, 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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 2: Poland Only

- 1/14/19 - 1 form, 14 itemgroups, 93 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
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 - 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 6: Eligibility Check, Laboratory Test

- 1/11/19 - 1 form, 4 itemgroups, 17 items, 1 language
Itemgroups: Administrative data, Check for Study Continuation, Elimination Criteria During The Study, Laboratory Tests - Blood
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

Study of Long-term Antibody Persistence After a Booster Dose of Menitorix Vaccine - 109664 - Visit 1

- 1/11/19 - 1 form, 15 itemgroups, 94 items, 1 language
Itemgroups: Administrative data, Informed Consent, Demographics, Eligibility Check, Inclusion Criteria, Exclusion Criteria, General Medical History / Physical Examination, Meningococcal Vaccination History, Hib Vaccination History, Pertussis Vaccination History, Disease History, Laboratory Tests - Blood, Medication, Study Conclusion, Investigator's Confirmation
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