ong-Term Antibody Persistence at 1, 3 and 5 Years After a fourth dose of GSK Biologicals' Hib-MenCY-TT Vaccine compared to Ac-tHIB.

• Conditions: Invasive disease caused by Haemophilus type b and Neisseria meningitidis serogroups C and Y; MedDRA version: 18.0Level: LLTClassification code 10028910Term: Neisseria meningitides meningitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10051931Term: Neisseria infection NOSSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-004060-22-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 443

Inclusion Criteria

•Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
­Year 1: 22 to 36 months of age.
­Year 3: 44 to 60 months of age.
­Year 5: 5 years post-dose 4 +/- 8 weeks
•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 fourth dose vaccination of study Hib-MenCY-TT-005/006
Are the trial subjects under 18? yes
Number of subjects for this age range: 487
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

Children should not have:
•received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
•had a history of H. influenzae type b, meningococcal serogroup C and Y diseases.

Study & Design

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