A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers

• Conditions: To assess the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers; MedDRA version: 16.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-000862-13-IT
• Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-06
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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: 200
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 enrollment 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 (Exceptions: 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) or tetanus toxoid (TT) 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 six months prior to 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 is considered as a contraindication to intramuscular injection.
12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature >= 38°C) within 3 days prior to enrollment.
13. Who have received systemic antibiotic treatment within 7 days prior to enrollment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified