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

• Conditions: 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; MedDRA version: 16.1Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2010-021528-81-HU
• Lead Sponsor: ovartis Vaccines and Diagnostics s.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-07
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

Male and female subjects: a)Healthy infants 2½ months of age (71 -79 days, inclusive), (only applicable to group I). b)Healthy infants 3½ 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 windowis 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 turns 11 years of age). f) Healthy infants 3 months of age (applicable to Groups V and VI).
2.For whom parent(s)/legal guardian(s) have given written informed consent according 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 1400
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 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 higher than 38 Centigrade 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.Any serious chronic or progressive disease according to the judgment of the investigator (e.g., 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 cardiac or renal failure or severe malnutrition);
11.Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of high dose systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 14 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
See protocol

Study & Design

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