Persistence of antibodies at 3, 4 and 6 years of age after vaccination with meningococcal, pneumococcal and Hib vaccines

Conditions: Healthy volunteers (prevention of invasive diseases caused by Haemophilus influenzae (type b) and Neisseria meningitidis serogroup C)
MedDRA version: 14.1Level: LLTClassification code 10027275Term: Meningococcal infection, unspecifiedSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2008-007846-69-DE

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 581

Inclusion Criteria

All subjects must satisfy the following criteria at study entry:
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female between, and including, 36 and 40 months of age at the time of Visit 1; between, and including, 48 and 52 months of age at the time of Visit 2; and between, and including, 72 and 76 months of age at the time of Visit 3.
•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.
•Subjects who previously participated in the 10PN-PD-DIT-011 and the 10PN-PD-DIT-017 BST: 011 studies, who received a full vaccination course with the vaccines corresponding to their group during the primary and booster studies and who were part, in the 10PN-PD-DIT-017 BST: 011 study, of the blood sampling subset.
Are the trial subjects under 18? yes
Number of subjects for this age range: 581
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

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:
•Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first blood sampling.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first blood sampling. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
•Administration of any additional meningococcal serogroup C, Hib, hepatitis B and pneumococcal vaccine since the end of 10PN-PD-DIT-017 BST: 011 study.
•History of meningococcal serogroup C, Haemophilus influenzae type b, hepatitis B and invasive pneumococcal diseases since the end of 10PN-PD-DIT-017 BST:011 study.
•Any confirmed or suspected immunosuppressive or immunodeficient condition since the end of the 10PN-PD-DIT-017 BST: 011 study, based on medical history and physical examination (no laboratory testing required).
•Administration of immunoglobulins and/or any blood products within the three months preceding the first blood sampling.