Study of a Novel Multicomponent Meningococcal Group B Vaccine When Given Alone or With Other Licensed Vaccines in Adults, Adolescents, Toddlers and Infants
- Conditions
- Meningococcal ImmunisationHealthy Volunteers
- Registration Number
- NCT04825223
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 576
Inclusion criteria :<br><br>-For US: Aged 10 to 25 years on the day of inclusion (10-25 years means from the day of<br>the 10th birthday to the day before the 26th birthday) For EU: Aged 42 to 89 days or 12<br>to 18 months or 10 to 50 years on the day of inclusion (42 to 89 days means from 42<br>days after birth to the 89th day after birth; 12-18 months means from the12th month<br>after birth to the day before the 19th month after birth; 10-50 years means from the<br>day of the 10th birthday to the day before the 51st birthday Participants or participant<br>and parent/legally acceptable representative are able to attend all scheduled visits and<br>to comply with all trial procedures Covered by health insurance (applicable depending on<br>local regulations) Participants who are overtly healthy as determined by medical<br>evaluation including medical history, physical examination, and judgement of the<br>Investigator<br><br>For adults: A female participant is eligible to participate if she is not pregnant or<br>breastfeeding and one of the following conditions applies:<br><br> - Is of non-childbearing potential. To be considered of non-childbearing potential, a<br> female must be post-menopausal for at least 1 year, or surgically sterile OR<br><br> - Is of childbearing potential and agrees to use an effective contraceptive method or<br> abstinence from at least 4 weeks prior to the first study intervention<br> administration until at least 4 weeks after the last study intervention<br> administration.<br><br>A female participant of childbearing potential must have a negative highly sensitive<br>pregnancy test (urine or serum as required by local regulation) the day of any dose of<br>study intervention<br><br>For adolescents: A female participant is eligible to participate if she is not pregnant<br>or breastfeeding and one of the following conditions applies:<br><br> - Is of non-childbearing potential. To be considered of non-childbearing potential, a<br> female must be pre-menarche OR<br><br> - Is of childbearing potential and agrees to use an effective contraceptive method or<br> abstinence from at least 4 weeks prior to the first study intervention<br> administration until at least 4 weeks after the last study intervention<br> administration A female participant of childbearing potential must have a negative<br> highly sensitive pregnancy test (urine or serum as required by local regulation) the<br> day of any dose of study intervention -For infants: Born at full term of pregnancy<br> (=37 weeks) and with a birth weight =2.5 kg or born after a gestation period of 27<br> through 36 weeks and medically stable as assessed by the investigator, based on the<br> following definition: Medically stable refers to the condition of premature<br> infants who do not require significant medical support or ongoing management for<br> debilitating disease and who have demonstrated a clinical course of sustained<br> recovery by the time they receive the first dose of study intervention - - -<br><br>Exclusion criteria:<br><br>-Known or suspected congenital or acquired immunodeficiency; or receipt of<br>immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within<br>the preceding 6 months or since birth for infants and toddlers; or long-term systemic<br>corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within<br>the past 3 months or since birth for infants and toddlers) History of any Neisseria<br>meningitidis infection, confirmed either clinically, serologically, or microbiologically<br>At high risk for meningococcal infection during the trial (specifically, but not limited<br>to, participants with persistent complement deficiency, with anatomic or functional<br>asplenia, or participants travelling to countries with high endemic or epidemic disease)<br>Individuals with active tuberculosis Known systemic hypersensitivity to latex or to any<br>of the vaccine components, or history of a life-threatening reaction to the vaccine(s)<br>used in the trial or to a vaccine containing any of the same substances For adults and<br>adolescents: Self-report of thrombocytopenia, contraindicating intra-muscular (IM)<br>vaccination * For infants and toddlers: Laboratory-confirmed thrombocytopenia, or known<br>thrombocytopenia, as reported by the parent/legally acceptable representative<br>contraindicating intramuscular vaccination Bleeding disorder, or receipt of<br>anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination For<br>infants and toddlers: History of intussusception Receipt of any vaccine in the 4 weeks<br>(28 days) preceding the first trial vaccination or planned receipt of any vaccine 4 weeks<br>before to 4 weeks after each trial vaccination or study visit with collection of blood<br>for immunogenicity assessments, except for influenza vaccination, which may be received<br>at least 2 weeks before or 2 weeks after any study vaccination. This exception includes<br>monovalent pandemic influenza vaccines and multivalent influenza vaccines Previous<br>vaccination against meningococcal B disease with either the study vaccines or another<br>licensed or investigational vaccine (i.e., mono- or polyvalent, polysaccharide, or<br>conjugate meningococcal vaccine containing serogroup B) For infants and toddlers:<br>Previous vaccination against meningococcal disease with either the study vaccines or any<br>other licensed or investigational vaccine containing serogroups A, C, W, Y; or<br>meningococcal serogroup B Receipt of immune globulins, blood or blood-derived products in<br>the past 3 months or since birth for infants and toddlers Receipt of oral or injectable<br>antibiotic therapy within 72 hours prior to the first immunogenicity blood draw For<br>infants: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis,<br>hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b,<br>Streptococcus pneumoniae, and /or rotavirus infection or disease, and receipt of more<br>than 1 previous dose of hepatitis B vaccine Participation at the time of study enrollment<br>(or in the 4 weeks preceding the first trial vaccination) or planned participation during<br>the present trial period in another clinical trial investigating a vaccine, drug, medical<br>device, or medical procedure Chronic illness that, in the opinion of the investigator, is<br>at a stage where it might interfere with trial conduct or completion Moderate or severe<br>acute illness/infection (according to the investigator's judgment), febrile illness<br>(temperature = 38.0°C or = 100.4°F). A prospective participant should not be enrolled in<br>the study until the condition has resolved or the febrile event has subsided History of<br>Guillain-Barré syndrome History of any neurologic disorders, including any seizures and<br>progressive neurologic disorders Deprived of freedom by an administrative or court order,<br>or in an emergency setting, or hospitalized involuntarily For adults and adolescents:<br>Identified as an investigator or employee of the investigator or study center with direct<br>involvement in the proposed study, or identified as an immediate family member (i.e.,<br>parent, spouse, natural or adopted child) of the investigator or employee with direct<br>involvement in the proposed study For infants and toddlers: Identified as a natural or<br>adopted child of the Investigator or employee with direct involvement in the proposed<br>study For adults and adolescents: Alcohol, prescription drug, or substance abuse that, in<br>the opinion of the Investigator, might interfere with the study conduct or completion<br><br>The above information is not intended to contain all considerations relevant to a<br>patient's poten
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with immediate adverse events (AEs);Number of participants with solicited injection site reactions or systemic reactions;Number of participants with unsolicited AEs;Number of participants with serious adverse events (SAEs);Number of participants with medically attended adverse events (MAAE)s;Number of participants with out-of-range biological test results;Antibody titers in the primary panel of MenB strains before primary vaccination;Antibody titers in the primary panel of MenB strains after primary vaccination
- Secondary Outcome Measures
Name Time Method Antibody titers in the primary panel of MenB strains after each vaccination;Antibody titers in the secondary panel of MenB strains (stage 1 and 2 only);Antibody titers in the primary panel of MenB strains (stage 2 only);Antibody titers against each of Men A, C, W, and Y strains