Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

• Conditions: Prophylaxis against Neisseria Meningitidis serogroup A, C,W and Y; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005392-90-Outside-EU/EEA
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-31
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Healthy male and female 2 month-old infants (55 – 89 days) on the day of consent.
2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
3. Infants whose parents or legal guardians can comply with study procedures including follow-up
Prior to receipt of 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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 135
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

Each subject must not have/have been:
1. previously received any meningococcal A, C, W and Y vaccines;
2. previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth;
3. progressive, unstable or uncontrolled clinical conditions;
4. a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy;
5. experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature = 38.0°C [100.4°F]) within the previous 3 days;
6. any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
7. received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth;
8. ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study;
9. any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw;
10. any condition which, 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;
11. received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study;
12. received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops):
13. relatives of site research staff working on this study.
Prior to receipt of study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. At subsequent vaccinations, if subjects meet any of
the original exclusion criteria listed above (with exception exclusion criteria 1, previous received the study vaccine), they should not receive additional vaccinations.

Study & Design

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