A PHASE 3B, OPEN LABEL, MULTI-CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF NOVARTIS MENINGOCOCCAL B RECOMBINANT VACCINE WHEN ADMINISTERED ALONE TO HEALTHY INFANTS ACCORDING TO DIFFERENT IMMUNIZATION SCHEDULES AND TO HEALTHY CHILDREN AGED 2 TO 10 YEARS
- Registration Number
- PER-051-11
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 59
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.
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method