Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00291967 |
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.
Condition | Intervention | Phase |
---|---|---|
Diphtheria Tetanus Pertussis Hepatitis B Hib Diseases Neisseria Meningitidis Serogroups A & C Diseases |
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluate the Feasibility of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6, 10 & 14 Weeks of Age |
Estimated Enrollment: | 525 |
Study Start Date: | November 2002 |
Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals’ Hib-MenAC mixed with GSK Biologicals’ Tritanrix™-HepB (3 different groups)
GSK Biologicals’ Tritanrix™-HepB + GSK Biologicals’ Hiberix™ GSK Biologicals’ Tritanrix™-HepB mixed with GSK Biologicals’ Hiberix™ + Wyeth Lederle’s Meningitec™
Ages Eligible for Study: | 6 Weeks to 10 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Study ID Numbers: | 759346 |
Study First Received: | February 14, 2006 |
Last Updated: | December 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00291967 History of Changes |
Health Authority: | Philippines: Bureau of Food and Drugs |
Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Cough Neisseria Meningitidis Diphtheria Tetanus Gram-Negative Bacterial Infections |
Virus Diseases Hepatitis Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Hepatitis B DNA Virus Infections |
Bacterial Infections Liver Diseases Hepatitis, Viral, Human Whooping Cough Diphtheria Infection Hepadnaviridae Infections Actinomycetales Infections Gram-Negative Bacterial Infections Virus Diseases |
Hepatitis Bordetella Infections Gram-Positive Bacterial Infections Digestive System Diseases Respiratory Tract Infections Respiratory Tract Diseases Corynebacterium Infections Hepatitis B DNA Virus Infections |