Prevention of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y
Conditions
Interventions
Product Name: Novartis Meningococcal ACWY Conjugate Vaccine
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Meningococcal g
Sponsors
Novartis Vaccines and Diagnostics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age = 37 weeks and a birth weight = 2.5 kg; 2.for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; 3.available for all the visits scheduled in the study; 4. in good health as determined by:·medical history,· physical examination and clinical judgment of the investigator 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
Exclusion criteria
Exclusion criteria: 1. who previously received any meningococcal vaccine; 2.who received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, HBV, H. influenzae type b (Hib) or Pneumococcus; 3. who have a previous ascertained or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping); 4. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 5. who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (³38.0°C) within the previous 3 days; 6. who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome); 7. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):a) receipt of any immunosuppressive therapy since birthb) receipt of immunostimulants since birthc) receipt of any sytemic corticosteroid since birth 8. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 9. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 10. who have taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who have received an oral or parenteral ß-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objectives To assess the immunogenicity of three doses of Chiron Men ACWY conjugate vaccine given at 2, 3, 4 or 2, 4, 6 months of age, as measured by the percentage of subjects with hSBA greater than 1:4 (i.e., the percent response), against N. meningitidis serogroups A, C, W and Y Safety Objectives To evaluate the safety and tolerability of Chiron Men ACWY conjugate vaccine when given concomitantly with other licensed pediatric vaccines at 2, 3, 4 or 2, 4, 6 months of age To evaluate the safety and tolerability of Chiron Men ACWY conjugate vaccine when given concomitantly with other licensed pediatric vaccines at 12 months of age ; Secondary Objective: ·To assess the immunogenicity of three doses of Chiron Men ACWY conjugate vaccine given at 2, 3, 4 or 2, 4, 6 months of age, as measured by hSBA geometric mean titer (GMT), against N. meningitidis serogroups A, C, W and Y To assess the immunogenicity of two doses of Chiron Men ACWY conjugate vaccine given at 2 and 4 months of age, as measured by hSBA GMT and percent response, against N. meningitidis serogroups A, C, W and Y To assess the immunogenicity of a booster dose of Chiron Men ACWY conjugate vaccine given at 12 months of age in a subset of subjects receiving the two dose regimen, as measured by hSBA GMT and percent response, against N. meningitidis serogroups A, C, W and Y ;Primary end point(s): Immunogenicity of the investigational vaccine after a full vaccination course (3 doses according to the UK vaccination schedule) as measured by the % of subject with hSBA=1:4 | — |
Countries
United Kingdom
Outcome results
None listed