Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents



Status:Completed
Conditions:Infectious Disease, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:10 - 17
Updated:2/11/2018
Start Date:July 2014
End Date:June 2016

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A Phase II Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

The purpose of this trial is to evaluate the immunogenicity and safety of MenACYW conjugate
vaccine compared to those of a licensed product, MENVEO vaccine and also evaluate MenACYW
conjugate vaccine when given alone compared to when given with Tdap vaccine and HPV vaccine.

Primary objective:

- To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine
when MenACYW conjugate vaccine is given alone compared to those when MENVEO vaccine is
given alone.

Secondary objective:

- To evaluate the antibody responses to the antigens present in MenACYW conjugate vaccine,
when MenACYW conjugate vaccine is given concomitantly with Tdap and HPV vaccines,
compared to those when it is given alone

- To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap
vaccine is given concomitantly with MenACYW conjugate vaccine and HPV vaccine, compared
to those when Tdap vaccine is given with HPV vaccine only

Observational objective:

- To describe the safety profile of MenACYW conjugate vaccine, compared to that of the
licensed vaccine MENVEO®, and when MenACYW conjugate vaccine is given with Tdap and HPV
vaccines.

Participants will receive their assigned vaccine and will be evaluated for immunogenicity and
safety. The duration of participation in the trial will be approximately 180 to 210 days.

Inclusion Criteria:

- Aged 10 to 17 years on the day of inclusion

- Informed consent form has been signed and dated by the parent(s) or another legally
acceptable representative

- Assent form has been signed and dated by the subject

- Subject and parent legally acceptable representative are able to attend all scheduled
visits and comply with all trial procedures.

Exclusion Criteria:

- Subject is pregnant, or lactating, or of childbearing potential (to be considered of
non-childbearing potential, a female must be pre-menarche, surgically sterile, or
using an effective method of contraception or abstinence from at least 4 weeks prior
to the first vaccination and until at least 4 weeks after the last vaccination)

- Participation in the 4 weeks preceding the first trial vaccination(s) or planned
participation during the present trial period in another clinical trial investigating
a vaccine, drug, medical device, or medical procedure

- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination(s) or
planned receipt of any vaccine in the 4 weeks prior to or following any trial
vaccination except for influenza vaccination, which may be received at least 2 weeks
before or after any study vaccines. This exception includes monovalent influenza
vaccines and multivalent influenza vaccines.

- Previous vaccination against meningococcal disease with either the trial vaccine or
any mono- or polyvalent polysaccharide or conjugate meningococcal vaccine containing
A, C, W, or Y antigens

- History of vaccination with any tetanus, diphtheria, or pertussis vaccine within the
previous 4 years

- Previous HPV vaccination

- Receipt of immune globulins, blood or blood-derived products in the past 3 months

- Known or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
within the preceding 6 months; or long-term systemic corticosteroid therapy
(prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

- History of meningococcal infection, confirmed either clinically, serologically, or
microbiologically

- At high risk for meningococcal infection during the trial (i.e., subjects with
persistent complement deficiency, with anatomic or functional asplenia, or subjects
travelling to countries with high endemic or epidemic disease)

- Known systemic hypersensitivity to any of the vaccine components, or history of a
life-threatening reaction to the vaccines used in the trial or to a vaccine containing
any of the same substances, including encephalopathy (e.g., coma, decreased level of
consciousness, prolonged seizures) within 7 days of administration of a previous
pertussis antigen-containing vaccine

- Personal history of Guillain-Barré syndrome

- Personal history of an Arthus-like reaction after vaccination with a tetanus
toxoid-containing vaccine within at least 10 years of the proposed study vaccination

- Verbal report of thrombocytopenia, contraindicating intramuscular vaccination

- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
contraindicating intramuscular vaccination

- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily

- Current alcohol abuse or drug addiction

- Chronic illness (e.g., HIV hepatitis B, hepatitis C) that, in the opinion of the
investigator, is at a stage where it might interfere with trial conduct or completion

- Moderate or severe acute illness/infection (according to investigator judgment) on the
day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject
should not be included in the study until the condition has resolved or the febrile
event has subsided

- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
blood draw

- Identified as an Investigator or employee of the Investigator or study center with
direct involvement in the proposed study, or identified as an immediate family member
(i.e., natural or adopted child) of the Investigator or employee with direct
involvement in the proposed study.
We found this trial at
36
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West Haven, UT
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Charleston, South Carolina 29412
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Wichita, KS
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