Status:
COMPLETED
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
Lead Sponsor:
GlaxoSmithKline
Conditions:
Haemophilus Influenzae Type b
Neisseria Meningitidis
Eligibility:
All Genders
31-33 years
Phase:
PHASE3
Brief Summary
This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are present...
Detailed Description
This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) ...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
- Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)
Exclusion
- Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
- History of H. influenzae type b, meningococcal serogroup C diseases.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00322335
Start Date
May 1 2006
End Date
September 1 2010
Last Update
October 20 2016
Active Locations (12)
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1
GSK Investigational Site
Almería, Spain, 04009
2
GSK Investigational Site
Burgos, Spain, 09005
3
GSK Investigational Site
Getafe/Madrid, Spain, 28905
4
GSK Investigational Site
Girona, Spain, 17002