Estudio en fase III, abierto, multicéntrico para evaluar la persistencia de anticuerpos a a largo plazo en niños hasta los 6 años de edad, tras una pauta completa de vacunación (primaria y de recuerdo) con la vacuna Hib-Men C o vacuna antimeningocócica C conjugada (MenC-CRM197 - Meningitec- o MenC-TT - NeisVac-C-) coadministrada con combinaciones que contienen DTPa y vacunas antineumocócicas conjugadas (10Pn-PD-DiT de GSK Biologicals o Prevenar) en los estudios de primovacunación 10PN-PD-DIT-011 (107005) y de recuerdo 10PN-PD-DIT-017 BST: 011 (109507).Persistence of antibodies after full vaccination course with GSK Biologicals? Menitorix or MenC conjugate vaccine, co-administered with DTPa or DTPa/Hib containing vaccine and pneumococcal conjugate vaccine, in children up to 6 years of age - HIB-MENC-TT-035 EXT: 10PN-PD-DIT-017
- Conditions
- iños sanos de ambos sexos vacunados en el estudio de primovacunación 107005 (10PN-PD-DIT-011) y en el estudio de la dosis de recuerdo 109507 (10PN-PD-DIT-017) BST: 011, que formaban parte del subgrupo en el estudio 10PN-PD-DIT-017 BST:011. Sólo se invitará a participar en el estudio a los sujetos a los que se les ha extraido una muestra de sangre en la fase de recuerdo.
- Registration Number
- EUCTR2008-007846-69-ES
- Lead Sponsor
- GlaxoSmithKline S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 600
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:
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
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 vaccine dose. (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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method