EUCTR2013-000145-39-ITActive, not recruitingNot Applicable
A Phase 3, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of Single Dose of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Toddlers 12 Months of Age, Compared to Single Dose of Meningococcal C Conjugate Vaccine
ovartis Vaccines and Diagnostics s.r.l0 sites1,000 target enrollmentStarted: May 2, 2013Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •In order to participate in this study, all subjects must meet ALL of the inclusion criteria
- •1. Male and female children between 12 months and 15 months old inclusive (minimum
- •365 days of age and maximum 15 months plus 29 days of age), who were born with
- •an estimated gestational age = 37 weeks;
- •2. For whom parent(s)/legal guardian(s) have given written informed consent after the
- •nature of the study has been explained according to local regulatory requirements;
- •3. Who the investigator believes that their parents/ guardians will be available for all the
- •visits and would comply with the requirements of the protocol (e.g., completion of the
- •Diary Cards, availability for study visits / safety phone calls);
- •4. Individuals in good health as determined by the outcome of medical history, physical
- •examination and clinical judgment of the investigator;
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1000
- •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
- •1. Subjects that had a previous confirmed or suspected disease caused by N.
- •meningitidis.
- •2. Who were previously exposed to clinically proven meningococcal disease or clinical
- •bacterial meningitis without further microbiologic characterization, i.e. possible
- •meningococcal disease.
- •3. Who have previously been immunized with a meningococcal vaccine or vaccine
- •containing meningococcal antigen(s) (licensed or investigational).
- •4. Who have received within 90 days prior to enrolment or are expected to receive
- •during the study period any investigational or non-registered product (drug or
- •5. Who have received or who are planning to receive any vaccines within 14 days before
- •and 30 days after administration of the study vaccine (Exception: Injectable influenza
- •vaccine may be administered up to 14 days prior to study vaccination and at least 14
- •days after study vaccination).
- •6. Who have a major congenital defect or a serious chronic disease.
- •7. Who have a history of any anaphylaxis, severe vaccine reactions, or allergy to any
- •vaccine components including diphtheria toxoid (CRM197) and latex.
- •8. Who required chronic administration (defined as more than 14 days) of
- •immunosuppressants or other immune-modifying drugs within six months prior to
- •the study vaccination. (For corticosteroids, this means prednisone, or equivalent, =
- •0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •9. Who received immunoglobulins and/or any blood products within 90 days prior study
- •vaccination or who have administration planned during the study period.
- •10. Who have any confirmed or suspected immunosuppressive or immunodeficient
- •condition, based on medical history and physical examination.
- •11. Who have any bleeding disorder which consider as a contraindication to intramuscular
- •injection or blood draw.
- •12. Who have experienced a significant acute infection or fever (defined as temperature =
- •38°C) within 3 days prior enrolment.
- •13. Who have received systemic antibiotic treatment within 7 days prior to enrolment.
- •There may be instances when individuals meet all entry criteria except one that relates to
- •transient clinical circumstances (e.g., body temperature elevation or recent use of
- •excluded medication or vaccine). Under these circumstances, a subject may be considered
- •eligible for study enrollment if the appropriate window for delay has passed,
- •inclusion/exclusion criteria have been rechecked, and if the subject is confirmed to be
Investigators
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