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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

In order to participate in this study, all subjects must meet ALL of the inclusion criteria
described.
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

described.
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
vaccine).
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
eligible.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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