Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00317187|
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : October 3, 2011
|Condition or disease||Intervention/treatment||Phase|
|Hib Disease Hepatitis B Diphtheria Pertussis Neisseria Meningitidis Serogroup Diseases Tetanus||Biological: DTPw-HBV/Hib-MenAC conjugate vaccine||Phase 3|
Randomized study with four groups to receive one of the following vaccination regimens after a dose of hepatitis B vaccine given at birth:
- One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HepB (3 different groups)
- GSK Biologicals' Tritanrix™-HepB/Hiberix™
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Partially Blinded Study to Assess Reactogenicity & Safety of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ in Healthy Infants After a Hepatitis B Birth Dose|
|Study Start Date :||June 2004|
- Day 0-3 after each dose, fever >38.5°C(axillary).
- Solicited events other than fever (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317187
|GSK Investigational Site|
|Bangkok, Thailand, 10400|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|