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)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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.
Exclusion criteria
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History of any meningococcal vaccine administration other than the vaccination administered in the primary study, V102_03 (NCT01272180);
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Current or previous, confirmed or suspected disease caused by N. meningitidis;
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Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrollment;
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History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component;
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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;
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Sexually active females that refuse to use to an "acceptable contraceptive method" through to 3 weeks following the study vaccination;
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Female subjects with a positive pregnancy test prior to the study vaccine being administered;
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Nursing (breastfeeding) mothers;
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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;
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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);
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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).
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Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
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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;
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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);
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Individuals who study personnel or immediate family members of study personnel including brother, sister, child, parent, or the spouse.
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Individuals who have experienced moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrolment.
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Who have received systemic antibiotic treatment within 7 days prior to enrollment.
Trial design
Primary purpose
Allocation
Interventional model
Masking
194 participants in 9 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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