Extension of a study conducted in adolescent and young adult healthy subjects to evaluate safety and antibody response after the administration of a booster dose of the investigational vaccine directed against Meningococcal A, B, C, Y and W strains 24 months after the second dose.

• Conditions: This study will evaluate the safety and immunogenicity of a booster dose of MenABCWY vaccine; either MenABCWY+OMV or MenABCWY+1/4OMV, administered to adolescent and young adults who previously received the same MenABCWY formulation in the primary study V102_03. This extension study will also assess the safety and immunogenicity non-inferiority of a single dose of MenABCWY in subject who received two doses of Bexsero or a single dose of Menveo in the primary study.; MedDRA version: 19.0Level: PTClassification code 10027202Term: Meningitis bacterialSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-003937-41-PL
• Lead Sponsor: GSK Vaccines S.r.l

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-02
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

1. Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03;
2. Individuals or the individual’s parents or legal guardian who have given written consent after the nature of the study has been explained according to local regulatory requirements;
3. Individuals who have given written assent as required by local regulations after the nature of the study has been explained to them according to local regulatory requirements;
4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
5. Individuals and/or or the individual’s parents or legal guardian who can comply with study procedures and are available for follow-up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 484
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03;
2. Current or previous, confirmed or suspected disease caused by N. meningitidis;
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
4. History of severe allergic reactions after previous vaccinations or hypersensitivity to
any vaccine component;
5. All sexually active females that have not used an acceptable contraceptive method(s)” for at least 2 months prior to study entry. Acceptable birth control methods are defined as one or more of the following:
a. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
b. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
c. Intrauterine device (IUD)
d. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject’s study entry;
6. Sexually active females that refuse to use to an acceptable contraceptive method”
through to 3 weeks following the study vaccination;
7. Female subjects with a positive pregnancy test prior to the study vaccine being
administered;
8. Nursing (breastfeeding) mothers;
9. Individuals with a history of illness or with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study;
10. Any serious, chronic, or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure, or severe malnutrition);
11. Subjects 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, = 20mg/day. Inhaled and topical steroids are allowed).
12. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study;
14. Administration or planned administration, of any vaccine not foreseen by the study protocol within 30 days prior study vaccination, and up to 30 days after the vaccination (with the exception of any licensed influenza vaccine which may be administered >14 days preceding or >14 days following the study vaccination);
15. Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
16. Individuals who have experienced moderate or severe acute infection and/or feve (defined as temperature 38°C) within 3 days prior to enrolment.
17. Who have received systemic antibiotic treatment within 7 days prior to enrolment.

Study & Design

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