Study to evaluate the safety of two doses of Novartis Meningococcal Group B Vaccine when administered to healthy adults from 18 to 50 Years of age and to collect blood donations to develop vaccines against Neisseria Meningitidis

• Conditions: Meningococcal Group B disease.; MedDRA version: 17.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-002972-95-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-30
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

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

1. Individuals of 18 through 50 of age on the day of informed consent.

2. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.

3. Individuals who can comply with study procedures including follow-up*.

4. Males
Or
Females of non-childbearing potential*
Or
Females of childbearing potential who are using an effective birth control method* which they intend to use for at least 30 days after the last study vaccination.

Prior to receipt of the second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
*Please refer to the footnote of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Each subject must not have:
1. Progressive, unstable or uncontrolled clinical conditions.

2. Hypersensitivity, including allergy, to any component of vaccines or medical equipment whose use is foreseen in this study.

3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.

4. Body weight = 50 Kg at the time of informed consent

5. Abnormal function of the immune system resulting from:
a. Clinical conditions.
b. Systemic administration of corticosteroids (PO/IV/IM) at any dose and for any duration within 90 days prior to informed consent.
c. Administration of antineoplastic and immunomodulating agents or radiotherapy at any dose and for any duration within 90 days prior to informed consent.

6. Received immunoglobulins or any blood products at any dose and for any duration from 3 months prior to informed consent.

7. Must not have chronic clinical significant conditions

8. Received an investigational or non-registered medicinal product within 30 days prior to informed consent

9. Study personnel as an immediate family or household member

10. Been administered any group B meningococcal vaccine at any time prior to informed consent.

11. Current or previous, confirmed or suspected disease caused by N. meningitidis.

12. Tested positive at the baseline pregnancy test.

13. Nursing (breastfeeding) mothers;

14. Any clinical condition manifesting in abnormal metabolic, hematological or cardiocirculatory measurements, including conditions which would so manifest if left untreated.

15. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Prior to receipt of the second administration of the study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects meet any of the original exclusion criteria listed above, they should not receive additional vaccinations.

Study & Design

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