Healthy volunteers (prevention of invasive diseases caused by Haemophilus influenzae (type b) and Neisseria meningitidis serogroup C) MedDRA version: 14.1 Level: LLT Classification code 10027275 Term: Meningococcal infection, unspecified System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10069533 Term: Haemophilus influenzae type b immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: 10-valent Streptococcus pneumoniae conjugate vaccine
Product Code: 10Pn-PD-DiT
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 C
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: At approximately 3, 4 and 6 years of age, in subjects who previously received a full vaccination course with Hib-MenC conjugate vaccine co-administrated with DTPa-containing and pneumococcal conjugate vaccines or with MenC conjugate vaccines co-administered with DTPa/Hib containing and GSK Biologicals’ 10Pn-PD-DiT conjugate vaccines, and who participated in the blood sampling subset of study 10PN-PD-DIT-017: •To evaluate the antibody persistence with respect to the MenC component of the Hib-MenC conjugate vaccine in terms of percentage of subjects with rSBA-MenC titres >= 1:8;Secondary Objective: At approximately 3, 4 and 6 years of age, in subjects who previously received a full vaccination course with Hib-MenC conjugate vaccine co-administrated with DTPa-containing and pneumococcal conjugate vaccines or with MenC conjugate vaccines co-administered with DTPa/Hib containing and GSK Biologicals’ 10Pn-PD-DiT conjugate vaccines, and who participated in the blood sampling subset of study 10PN-PD-DIT-017. • To evaluate the antibody persistence with respect to the components of the Hib-MenC conjugate vaccine in terms rSBA-MenC titres and anti-PRP antibody concentrations • To evaluate the antibody persistence with respect to the components of GSK Biologicals’ pneumococcal conjugate vaccine in terms of antibody concentrations (at 3, 4 and 6 years of age) and opsonophagocytic activity (at 3 and 4 years of age only) against vaccine pneumococcal serotypes and anti-protein D antibody concentrations (at 3, 4 and 6 years of age). •To evaluate the persistence of anti-HBs antibodies ;Primary end point(s): Persistence of immunogenicity with respect to components of the Hib-MenC conjugate vaccine, at 3, 4 and 6 years of age •rSBA-MenC titres >= 1:8 ;Timepoint(s) of evaluation of this end point: At 3, 4 and 6 years of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Persistence of immunogenicity with respect to components of the Hib-MenC conjugate vaccine, at 3, 4 and 6 years of age (on secondary readouts). 1. rSBA-MenC titres 2. Anti-PRP antibody concentrations Persistence of immunogenicity with respect to components of GSK Biologicals’ pneumococcal conjugate vaccine, at 3, 4 and 6 years of age. 3. Antibody concentrations against vaccine pneumococcal serotypes 4. Concentrations of antibodies against protein D Persistence of immunogenicity with respect to components of GSK Biologicals’ pneumococcal conjugate vaccine, at 3 and 4 years of age. 5. Opsonophagocytic activity against vaccine pneumococcal serotypes Persistence of immunogenicity of anti-Hepatitis B antibodies, at 3, 4 and 6 years of age. 6. anti-HBs antibody concentrations Safety 7.Serious Adverse Events (SAEs) occurring from the last study contact of the booster study 10PN-PD-DIT-017 BST:011 to the end of this persistence study. ;Timepoint(s) of evaluation of this end point: 1.at 3, 4 and 6 years of age 2.at 3, 4 and 6 years of age 3.at 3, 4 and 6 years of age 4. at 3, 4 and 6 years of age 5. at 3 and 4 years of age 6. at 3, 4 and 6 years of age 7. from the last contact of the booster study 10PN-PD-DIT-017 BST:011 to the end of this persistence study | — |
Countries
Germany, Spain
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed