Primary & Booster Immunogenicity Study of GSK Biologicals' Hib-MenC Versus a Licensed Men-C Vaccine
NCT00258700 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478
Last updated 2016-09-21
Summary
The purpose of this study is to demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix™-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel™ when given according to a 2, 3, 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age.
Conditions
- Haemophilus Influenzae Type b
- Neisseria Meningitidis
Interventions
- BIOLOGICAL
-
Haemophilus influenzae type b- and meningococcal (vaccine)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Weeks
- Max Age
- 12 Weeks
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-02-28
- Primary Completion
- 2006-07-31
- Completion
- 2006-07-31
Countries
- Poland
- United Kingdom
Study Locations
More Related Trials
-
Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
NCT00323050 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT and Hib-MenC-TT or Meningitec™ in Healthy Toddlers
NCT00135564 ·Status: COMPLETED ·Phase: PHASE2
-
Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
NCT00134719 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
NCT00129129 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
NCT00345579 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
NCT00289783 ·Status: COMPLETED ·Phase: PHASE3
-
Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants
NCT00586612 ·Status: COMPLETED ·Phase: PHASE3
-
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
NCT00345683 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
NCT00135486 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Reactogenicity & Immunogenicity Study to Evaluate a Booster Dose of GSK Biologicals' Hib-MenC Given With Priorix™ in Toddlers (13-14 m) Primed With 3 Doses of Hib and MenC-CRM197
NCT00263653 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
NCT01978093 ·Status: COMPLETED ·Phase: PHASE3
-
Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014
NCT00614614 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age).
NCT00352963 ·Status: COMPLETED ·Phase: PHASE3
-
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
NCT00463437 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
NCT00317109 ·Status: COMPLETED ·Phase: PHASE3
-
Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
NCT00891176 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate GSK Biologicals' GSK2197870A Vaccine Given as Primary Course in Infants
NCT00871338 ·Status: COMPLETED ·Phase: PHASE2
-
Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
NCT00291967 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity and Safety of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine in Infants and Children
NCT01428908 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants
NCT02096263 ·Status: COMPLETED ·Phase: PHASE3
-
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
NCT00291343 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK)'s Infanrix Hexa Vaccine (DTPa-HBV-IPV/Hib) Versus MCM Vaccine BV's Vaxelis Vaccine (DTaP5-HBV-IPV-Hib) in Healthy Infants and Toddlers
NCT04535037 ·Status: COMPLETED ·Phase: PHASE4
-
Phase 3 Study of A Group A, C Polysaccharide Meningococcal and Type b Haemophilus Influenzal Conjugate Vaccine
NCT01580033 ·Status: COMPLETED ·Phase: PHASE3
-
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered as a Booster Dose
NCT01171989 ·Status: COMPLETED ·Phase: PHASE2
-
Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.
NCT00317161 ·Status: COMPLETED ·Phase: PHASE3