A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccines in Healthy Toddlers

• Conditions: Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W); MedDRA version: 18.0Level: PTClassification code 10058858Term: Meningococcal bacteraemiaSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 18.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004367-20-FI
• Lead Sponsor: Sanofi Pasteur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-30
• Last Update Posted: 14 March 2016

Recruitment & Eligibility

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

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 12 to 23 months on the day of the first study visit
2) Born at full term of pregnancy (= 37 weeks) or with a birth weight = 2.5 kg (5.5 pounds)
3) Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5) Covered by health insurance where applicable

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

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines
3) Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y
4) Receipt of immune globulins, blood, or blood-derived products in the past 3 months
5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (= 2mg/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
6) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
7) At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease)
8) Known systemic hypersensitivity to any of the vaccine components, history of a life-threatening reaction to the vaccines used in the trial, or to a vaccine containing any of the same substances
9) Known systemic hypersensitivity to latex
10) Known thrombocytopenia, as reported by the parent/legally acceptable representative
11) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
12) Personal history of Guillain-Barré syndrome (GBS)
13) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Study & Design

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