Clinical Trial 50403

Miami, FL 33156


Summary:

PHASE 2

The purpose of this study:

This study is designed to describe the immunogenicity and safety of 2 doses of N. meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 2 or 4 years in adolescents aged 11 to 15 years at enrolment.

  • 11 - 14 years old (i.e., 14 years + 364 days at first vax)              
  • Number of visits: 14 visits: 6 site / 8 phone calls
  • 3 VACCINES
  • 30-day diary post Vaccines
  • Proof of VAX needed

           


Inclusion Criteria

All participants must satisfy ALL the following criteria at study entry:

  • Participants or/and participants’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of the eDiaries, return for follow-up visits and is available for telephone calls).
  • Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure.
  • A male or female between, and including, 11 and 14 years of age (i.e., 14 years + 364 days) at the time of the first vaccination.
  • Healthy participants as established by medical history, physical examination and clinical judgement of the investigator before entering into the study.
  • Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, hysterectomy, bilateral salpingectomy or bilateral ovariectomy.
  • Female participants of childbearing potential may be enrolled in the study, if the participant:
    • has practiced adequate contraception for 30 days prior to first vaccination, and
    • has a negative pregnancy test* on the day of vaccination, and
    • has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination.
  • Urine samples for pregnancy testing will be collected from female participants of childbearing potential at Visit 1, Visit 3 and Visit 5 prior to the vaccination.

  

EXCLUSION CRITERIA

Medical conditions

  • Current or previous, confirmed or suspected disease caused by N. meningitidis
  • Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.
  • Progressive, unstable or uncontrolled clinical conditions.
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
    • Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.      
  • Abnormal function or modification of the immune system resulting from:
    •  Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
    •  Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
    • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
    • Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

 

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.
  • Previous vaccination with any meningococcal (MenB or MenACWY) vaccine at any time prior to informed consent/ assent (as applicable) with the exception of meningococcal C (conjugated or polysaccharide) vaccination, if the last dose of MenC was received at ≤24 months of age.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of study vaccine/product or planned administration before the next blood sampling visit.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/product dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum of 20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.

 

Prior/Concurrent clinical study experience

  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).

Other Exclusions

  • Child in care (Please refer to the Glossary of terms for the complete definition of child in care)**
  • Pregnant or lactating female.
  • Female planning to become pregnant / planning to discontinue contraceptive precautions during the windows reported in the inclusion criterion.
  • History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator
  • Any study personnel or immediate dependents, family, or household members.

 


Qualified Participants May Receive:

Compensation up to $820


Available At:

Advanced Clinical Research

8600 SW 92ND Street, Suite #104

Miami, FL 33156

Phone # 786-633-3081

Fax # 786-579-2075

Email: info@aclinicalresearch.com

 


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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.