Prevention of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y
Conditions
Interventions
Product Name: Chiron Meningococcal ACWY Conjugate Vaccine (with an without adjuvant)
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: Meningococcal group A
Sponsors
Chiron S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. healthy 12-=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Children who should not be enrolled in the study are those: 1.whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2.who have previously received any meningococcal vaccine; 3.who have a previous ascertained or suspected disease caused by N. meningitidis; 4.who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection; 5.who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component; 6.who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature =38.0°C or rectal temperature =38.5°C) within 3 days previous to immunization; 7.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) 8.who have received another vaccine within the past 30 days from first or second immunization or any blood draw 9.who have received any investigational agent (including vaccine) within the past 90 days from first or second immunization or any blood draw 10.who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): a)administration of any immunosuppressive therapy b)administration of any immunostimulants c)administration of any sytemic corticosteroid administered for more than 4 days in the previous 30 days 11.with a suspected or known HIV infection or HIV related disease; 12.who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation; 13.with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding; 14.who have a history of any seizure disorder; 15.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 of antibiotic); 16.who with their parents/legal guardians are planning to leave the area of the study site before the end of the study period; 17.with any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objective: To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine in healthy children aged 36-<60 months, as measured by the percentage of subjects with hSBA =1:4 (i.e., the percentage of responders) against N. meningitidis serogroups A, C, W and Y. Safety Objective To evaluate the safety and tolerability of Men ACWY Ad+ or Men ACWY Ad- or Men ACWY PS when administered to healthy children 12-<60 months old. Ad-: without adjuvant Ad+: with adjuvant;Secondary Objective: To compare the functional immune response 28 days after administration of one dose of Men ACWY Ad- with that of a Men ACWY PS vaccine, as measured by hSBA geometric mean titers (GMTs) and hSBA =1:8 against N. meningitidis serogroups A, C, W and Y. ;Primary end point(s): Immunogenicity after a single dose either of Chiron MenACWY Ad- Conjugate Vaccine or MenACWY PS vaccine, as measured by the % of subject with hSBA titer =1:4 at 28 days after vaccination in subject 36-<60 months old. | — |
Countries
Finland
Outcome results
None listed