Phase 2, Observer-Blind, Placebo-Controlled, Randomized, Multi-Center Extension Study to Evaluate the Safety and Immunogenicity of a Booster Dose of a MenABCWY Vaccine Administered 24 Months Following the Primary Series to Adolescents and Young Adults Who Participated in V102_03 (NCT01272180)

Completed · Phase 2 · Has a placebo group

Conditions studied: Meningococcal Disease

In brief

The purpose of this extension study is to evaluate the immunogenicity and safety of a booster dose of a MenABCWY vaccine, administered 24 months after completion of the primary vaccination series, in subjects who previously received the same vaccine formulation in study V102\_03 (NCT01272180) (Groups I and II). Antibody persistence at 24 and 36 months after the primary vaccination and 12 months after the booster dose will also be evaluated in these subjects. In addition, safety and immunogenicity of two investigational MenABCWY vaccine formulations (either a MenABCWY+ OMV or a MenABCWY+¼ OMV) will be assessed in subjects who previously received two doses of MenB vaccine (Group III) or one dose of Menveo vaccine (Group IV). These subjects will be followed for safety and immunogenicity for 12 months after vaccination in study V102\_03E1.

Key facts

Study ID: NCT01992536
Run by: Novartis Vaccines
People needed: 194
Starts: 2013-12-01
Expected to finish: 2015-04-01
Last updated by the study team: 2016-10-25

Who can join

Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Males and females that received both vaccinations and completed the Study Termination visit in the primary study, V102_03 (NCT01272180);
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;
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;
Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator;
Individuals and/or or the individual's parents or legal guardian who can comply with study procedures and are available for follow-up.

You may not qualify if…

History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
Current or previous, confirmed or suspected disease caused by N. meningitidis;
Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
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:
Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
Intrauterine device (IUD)
Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry;
Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
Female subjects with a positive pregnancy test prior to the study vaccine being administered;
Nursing (breastfeeding) mothers;
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;
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);
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).
Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
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;
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);
Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
Who have received systemic antibiotic treatment within 7 days prior to enrollment.

Where it is running

Site 23, Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 — Birmingham, Alabama, United States
Site 24, Madera Family Medical Group 1111 West 4th Street — Madera, California, United States
Site 25, Center for Clinical Trials LLC 16660 Paramount Blvd, Suite 301 — Paramount, California, United States
Site 28, Kentucky Pediatric/Adult Research 201 South 5th Street — Bardstown, Kentucky, United States
Site 21, Bluegrass Clinical Research Inc. 5512 Bardstown Road, Suite 2 — Louisville, Kentucky, United States
Site 26, Ohio Pediatric Research Association 7200 Poe Ave, Suite 200 — Dayton, Ohio, United States
Site 27, Ohio Pediatric Research Association 1775 Delco Park Drive — Kettering, Ohio, United States
Site 22, Focus Research Group 201 Signature Place — Lebanon, Tennessee, United States
Site 15, Specjalistyczna Przychodnia Lekarska Internistyczno-Pediatryczna, Juniperus" s.c. — ul.Kościuszki 41, Izabelin, Poland
Site 13, Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska — Ul. Braci Kiemliczów 14, Kraków, Poland
Site 12, NZOZ PRAKTIMED Sp.zo.o — ul.Strzelców 15, Kraków, Poland
Site 14, Klinika Pediatrii Centrum Medycznego Kształcenia Podyplomowego,Szpital Bielański — Ul. Cegłowska 80, Warszawa, Poland
Site 11, Katedra i Klinika Pediatrii i Chorób Infekcyjnych — ul.O.Bujwida 44, Wrocław, Poland

Full record on ClinicalTrials.gov

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