Meningococcal disease MedDRA version: 21.0 Level: LLT Classification code 10028911 Term: Neisseria meningitidis infection NOS System Organ Class: 100000004862 MedDRA version: 21.0 Level: LLT Classification code 10070124 Term: Neisseria meningitidis test positive System Organ Class: 100000004848
Conditions
Sponsors
Pfizer Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • A male or female between, and including, 12 and 14 months of age at the time of the first vaccination. • Written informed consent obtained from the parent(s)/LAR(s) of the subject. • Healthy subjects as established by medical history and clinical examination before entering into the study. • Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry. Are the trial subjects under 18? yes Number of subjects for this age range: 800 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Child in care. • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period. • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group). • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). • Previous vaccination against Neisseria meningitidis. • Previous booster vaccination against Streptococcus pneumoniae. • Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis. • History of meningococcal disease. • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. • Family history of congenital or hereditary immunodeficiency. • History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines. • Major congenital defects or serious chronic illness. • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. • Acute disease and/or fever at the time of enrolment. • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate the immunogenicity of MenACWY-TT after administration of 1 dose in groups ACWY1d and ACWY2d or 2 doses in group ACWY2d with respect to Serum Bactericidal Assay using rabbit complement (rSBA) MenA/C/W-135/Y titres, 1 month after administration of MenACWY-TT in the ACWY1d and ACWY2d groups. - To evaluate the long-term persistence of the immune response induced by 1 or 2 doses of MenACWY-TT with respect to rSBA-MenA/C/W-135/Y titres, 1, 3 and 5 years after the last vaccination in the ACWY1d and ACWY2d groups. - To demonstrate the non-inferiority of the immune response to MenACWY-TT when co-administered with Prevenar 13 versus MenACWY-TT given alone 1 month after vaccination. - To demonstrate the non-inferiority of the immune response to Prevenar 13 when co-administered with MenACWY-TT versus Prevenar 13 given alone 1 month after vaccination.;Secondary Objective: -Immunogenicity of MenACWY-TT after 1 dose in groups ACWY1d and ACWY2d or 2 doses in group ACWY2d with respect to SBA using human complement (hSBA-MenA/C/W-135/Y) titres in a subset of subjects -Immunogenicity of MenACWY-TT after 1 dose with respect to rSBA-MenA/C/W-135/Y titres 1 month after administration in groups Co-ad and PCV-13 -Immune response to Prevenar 13 co-administered with MenACWY-TT or administered alone with respect to antibody concentrations and titres against pneumococcal antigens 1 month after administration in groups Co-ad and PCV-13 -Long-term antibody persistence with respect to hSBA and rSBA MenA/C/W-135/Y titres, 1, 3 and 5 years after last vaccination -Safety and reactogenicity in terms of solicited and unsolicited symptoms, serious adverse events (SAEs) and New Onset of Chronic Illnesses following each study vaccine dose -SAEs related to study vaccine administration and any event related to lack of vaccine efficacy, 1, 3 and 5 years after last vaccination;Primary end point(s): - Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres = 1:4, = 1:8 and titres. - Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres = 1:8, = 1:128 and titres in the PCV-13 group. - Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres = 1:128 and titres in the ACWY1d, ACWY2d and Co-ad groups. - Percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres = 1:4, =1:8 and titres in a subset of subjects in the ACWY1d and ACWY2d groups. - Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres = 1:8, =1:128 and titres in the Co-ad and PCV-13 groups - Percentage of subjects with anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations = 0.15 µg/ml, = 0.26 µg/ml and = 0.35 µg/ml in the Co-ad and PCV-13 groups - Percentage of subjects with anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F OPA titres = 1:8 and titres in the Co-ad and PCV-13 groups.;Timepoint(s) of evaluation of this end point: - hSBA titres = 1:4, = 1:8 and titres: One month after administration of 1 dose of MenACWY-TT in a subset of subjects in the ACWY1d and ACWY2d groups and 2 doses in the ACWY2d group. - rSBA titres = 1:8, = 1:128 and titres: One month after administration of 1 dose of MenACWY-TT. - hSBA titres = 1:4, =1:8 and titres and rSBA titres = 1:8, =1:128 and titres: At Years 1, 3 and 5. - Pneumocococcal antibodies: One month after administration of Prevenar 13. | — |
Countries
Australia, Canada, Czech Republic, Turkey
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc
Outcome results
None listed