Test STudy67
Recruiting
100 years or below
Male
Phase
N/A
2 Locations
Brief description of study
-For US: Aged 10 to 25 years on the day of inclusion ("10-25 years" means from the day of
the 10th birthday to the day before the 26th birthday) For EU: Aged 42 to 89 days or 12 to
18 months or 10 to 50 years on the day of inclusion ("42 to 89 days" means from 42 days
after birth to the 89th day after birth; "12-18 months" means from the12th month after
birth to the day before the 19th month after birth; "10-50 years" means from the day of the
10th birthday to the day before the 51st birthday Participants or participant and
parent/legally acceptable representative are able to attend all scheduled visits and to
comply with all trial procedures Covered by health insurance (applicable depending on local
regulations) Participants who are overtly healthy as determined by medical evaluation
including medical history, physical examination, and judgement of the Investigator
For adults: A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a
female must be post-menopausal for at least 1 year, or surgically sterile OR
- Is of childbearing potential and agrees to use an effective contraceptive method or
abstinence from at least 4 weeks prior to the first study intervention administration
until at least 4 weeks after the last study intervention administration.
A female participant of childbearing potential must have a negative highly sensitive
pregnancy test (urine or serum as required by local regulation) the day of any dose of
study intervention
For adolescents: A female participant is eligible to participate if she is not pregnant or
breastfeeding and one of the following conditions applies:
- Is of non-childbearing potential. To be considered of non-childbearing potential, a
female must be pre-menarche OR
- Is of childbearing potential and agrees to use an effective contraceptive method or
abstinence from at least 4 weeks prior to the first study intervention administration
until at least 4 weeks after the last study intervention administration A female
participant of childbearing potential must have a negative highly sensitive pregnancy
test (urine or serum as required by local regulation) the day of any dose of study
intervention -For infants: Born at full term of pregnancy (≥37 weeks) and with a birth
weight ≥2.5 kg or born after a gestation period of 27 through 36 weeks and medically
stable as assessed by the investigator, based on the following definition: "Medically
stable" refers to the condition of premature infants who do not require significant
medical support or ongoing management for debilitating disease and who have
demonstrated a clinical course of sustained recovery by the time they receive the
first dose of study intervention - - -
Exclusion criteria:
-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 since birth for infants and toddlers; or long-term systemic
corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within
the past 3 months or since birth for infants and toddlers) History of any Neisseria
meningitidis infection, confirmed either clinically, serologically, or microbiologically At
high risk for meningococcal infection during the trial (specifically, but not limited to,
participants with persistent complement deficiency, with anatomic or functional asplenia,
or participants travelling to countries with high endemic or epidemic disease) Individuals
with active tuberculosis Known systemic hypersensitivity to latex or to any of the vaccine
components, or history of a life-threatening reaction to the vaccine(s) used in the trial
or to a vaccine containing any of the same substances For adults and adolescents:
Self-report of thrombocytopenia, contraindicating intra-muscular (IM) vaccination * For
infants and toddlers: Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as
reported by the parent/legally acceptable representative contraindicating intramuscular
vaccination Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding
inclusion, contraindicating IM vaccination For infants and toddlers: History of
intussusception Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial
vaccination or planned receipt of any vaccine 4 weeks before to 4 weeks after each trial
vaccination or study visit with collection of blood for immunogenicity assessments, except
for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after
any study vaccination. This exception includes monovalent pandemic influenza vaccines and
multivalent influenza vaccines Previous vaccination against meningococcal B disease with
either the study vaccines or another licensed or investigational vaccine (i.e., mono- or
polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroup B) For
infants and toddlers: Previous vaccination against meningococcal disease with either the
study vaccines or any other licensed or investigational vaccine containing serogroups A, C,
W, Y; or meningococcal serogroup B Receipt of immune globulins, blood or blood-derived
products in the past 3 months or since birth for infants and toddlers Receipt of oral or
injectable antibiotic therapy within 72 hours prior to the first immunogenicity blood draw
For infants: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis,
hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b,
Streptococcus pneumoniae, and /or rotavirus infection or disease, and receipt of more than
1 previous dose of hepatitis B vaccine Participation at the time of study enrollment (or in
the 4 weeks preceding the first trial vaccination) or planned participation during the
present trial period in another clinical trial investigating a vaccine, drug, medical
device, or medical procedure Chronic illness 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 the investigator's judgment), febrile illness
(temperature ≥ 38.0°C or ≥ 100.4°F). A prospective participant should not be enrolled in
the study until the condition has resolved or the febrile event has subsided History of
Guillain-Barré syndrome History of any neurologic disorders, including any seizures and
progressive neurologic disorders Deprived of freedom by an administrative or court order,
or in an emergency setting, or hospitalized involuntarily For adults and adolescents:
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.,
parent, spouse, natural or adopted child) of the investigator or employee with direct
involvement in the proposed study For infants and toddlers: Identified as a natural or
adopted child of the Investigator or employee with direct involvement in the proposed study
For adults and adolescents: Alcohol, prescription drug, or substance abuse that, in the
opinion of the Investigator, might interfere with the study conduct or completion
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Detailed description of study
The research study is being done to understand both why and how scleroderma and related female-biased diseases affect women and men differently. Though we do not know what causes these diseases, we do know that women are much more likely to develop them than men. We are studying how the body’s immune system differs between men and women with these conditions, and comparing this to people who do not have these diseases.
We are looking for men and women without scleroderma and related diseases (control group) to have one study visit that includes a physical exam and blood collection. We will also collect information about you from your medical record for up to 5 years. Participants will receive a stipend of $50 for participating.
You must not have scleroderma, pulmonary hypertension, diseases with similarities to scleroderma (including myositis, lupus, Sjogren’s syndrome, or rheumatoid arthritis), or other conditions that affect your immune system.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Acne
-
Age: 100 years or below
-
Gender: Male
Inclusion Criteria:
Exclusion Criteria:
Updated on
04 Aug 2024.
Study ID: IRB897123