ong-term persistence study to assess a booster dose of GSK Biologicals' Hib-MenC.

Active, not recruiting

• Conditions: The prevention of invasive diseases caused by Haemophilus influenzae type b and Neisseria meningitidis serogroup C.; MedDRA version: 14.1Level: PTClassification code 10061190Term: Haemophilus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2006-000518-19-ES
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-08
• Last Update Posted: 28 August 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 184

Inclusion Criteria

?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 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.
?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 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 184
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified