None listed
Conditions
Interventions
SUBJECTS WILL BE INCLUDED IN THE STUDY IF IN GOOD HEALTH AS JUDGED BY PHYSICAL EXAMINATION AND MEDICAL HISTORY AND IF THEY MEET ALL OTHER INCLUSION CRITERIA AND NO INCLUSION CRITERIA. A TOTAL OF APPRO
250 SUBJECTS, APPROXIMATELY 3 1/2 MONTHS F AGE, WILL BE ENROLLED INTO GROUP II (125 SUBJECTS WILL BE ENROLLED IN GROUP IIa AND 125 IN GROUP IIb)
250 SUBJECTS, APPROXIMATELY 6 MONTHS OF AGE, WILL BE ENROLLED INTO GROUP III (125 SUBJECTS WILL BE ENROLLED IN GROUP IIIa AND 125 IN GROUP IIIb)
AND 400 SUBJECTS, 2 TO 10 YEARS OF AGE (I00 SUBJECTS 2-5 YEARS OF AGE WILL BE ENROLLED IN GROUP IVa AND 300 SUBJECTS 6-10 YEARS OF AGE IN GROUP IVb).
AT SCREENING, AFTER OBTAINING A WRITTEN INFORME
GROUP I: APPROXIMATELY 10 MONTHS
GROUP II: APPROXIMATELY 9 MONTHS
GROUP III: APPROXIMATELY 6 MONTHS
GROUP IV: APPROXIMATELY 3 MONTHS
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
2 Years to 6 Years
Inclusion criteria
Inclusion criteria: 1. HEALTHY INFANTS AND CHILDREN ACCORDING TO THE FOLLOWING AGE GROUPS: A) HEALTHY INFANTS 2 ½ MONTHS OF AGE (71-79 DAYS, INCLUSIVE), (ONLY APPLICABLE TO GROUP I) B) HEALTHY INFANTS 3 ½ MONTHS OF AGE (101-109 DAYS, INCLUSIVE), (ONLY APPLICABLE TO GROUP II) C) HEALTHY INFANTS 6 MONTHS OF AGE (ONLY APPLICABLE TO GROUP III) (THE AGE WINDOW IS DEFINED AS THE FIRST DAY THE SUBJECT TURNS 6 MONTHS OF AGE UP TO THE DAY BEFORE THE SUBJECT TURNS 7 MONTHS OF AGE). D) HEALTHY CHILDREN 2 TO 5 YEARS OF AGE (ONLY APPLICABLE TO GROUP IVa) (THE AGE WINDOW IS DEFINED AS THE FIRST DAY THE SUBJECT TURNS 2 YEARS OF AGE UP TO THE DAY BEFORE THE SUBJECT TURNS 6 YEARS OF AGE). E) HEALTHY CHILDREN 6 TO 10 YEARS OF AGE (ONLY APPLICABLE TO GROUP IVb) (THE AGE WINDOW IS DEFINED AS THE FIRST DAY THE SUBJECT TURNS 6 YEARS OF AGE UP TO THE DAY BEFORE THE SUBJECT TURS 11 YEARS OF AGE). 2. FOR WHOM PARENT(S)/LEGAL GUARDIAN(S) HAVE GIVEN WRITTEN INFORMED CONSENT ACOORDING TO LOCAL REGULATIONS AFTER THE NATURE OF THE STUDY HAS BEEN EXPLAINED; 3. AVAILABLE FOR ALL THE VISITS SCHEDULED IN THE STUDY; 4. INDIVIDUALS IN GOOD HEALTH AS DETERMINED BY THE OUTCOME OF MEDICAL HISTORY, PHYSICAL EXAMINATION AND CLINICAL JUDGMENT OF THE INVESTIGATOR.
Exclusion criteria
Exclusion criteria: 1. SUBJECTS WHOSE PARENT(S)/LEGAL GUARDIAN(S) ARE UNWILLING OR UNABLE TO GIVE WRITTEN INFORMED CONSENT TO PARTICIPATE IN THE STUDY; 2. CHILDREN´S PARENTS OR LEGAL GUARDIAN WHO ARE NOT ABLE TO COMPREHEND AND TO FOLLOW ALL REQUIRED STUDY PROCEDURES FOR THE WHOLE PERIOD OF THE STUDY. 3. HISTORY OF ANY MENINGOCOCCAL B VACCINE ADMINISTRATION; 4. PREVIOUS ASCERTAINED OR SUSPECTED DISEASE CAUSED BY N. MENINGITIDIS; 5. HOUSEHOLD CONTACT WITH AND/OR INTIMATE EXPOSURE TO AN INDIVIDUAL WITH LABORATORY CONFIRMED N. MENINGITIDIS; 6. HISTORY OF SEVERE ALLERGIC REACTION AFTER PREVIOUS VACCINATIONS OR HYPERSENSITIVITY TO ANY VACCINE COMPONENT 7. SIGNIFICANT ACUTE OR CHRONIC INFECTION WITHIN THE PREVIOUS 7 DAYS OR TEMPERATURE ≥ 38°C WITHIN THE PREVIOUS DAY OF RECEIVING THE STUDY VACCINE; 8. ANTIBIOTICS TREATMENT WITHIN 6 DAYS PRIOR TO ENROLLMENT; 9. INDIVIDUALS WITH HISTORY OF ALLERGY TO VACCINE COMPONENTS. 10.NY SERIOUS CHRONIC OR PROGRESSIVE DISEASE ACCORDING TO THE JUDGMENT OF THE INVESTIGATOR (eg., NEOPLASM, DIABETES MELLITUS TYPE I, CARDIAC DISEASE, HEPATIC DISEASE, NEUROLOGICAL DISEASE OR SEIZURE, EITHER ASSOCIATED WITH FEVER OR AS PART OF AN UNDERLYING NEUROLOGICAL DISORDER OR SYNDROME, AUTOIMMUNE DISEASE, HIV INFECTION OR AIDS, OR BLOOD DYSCRASIAS OR DIATHESIS, SIGNS OF CADIAC OR RENAL FAILURE OR SEVERE MALNUTRITION).
Countries
Brazil, Hungary, Peru, Spain
Contacts
Public ContactJOSE CARLOS VELIZ
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed