Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT03632720
Eligibility Criteria:
Inclusion Criteria:
* Aged \>= 56 to less than or equal to (\<=) 89 days on the day of the first study visit.
* Born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kilogram (kg) (or 5 lb and 8 oz).
* Informed consent form had been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations).
* Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria:
\-- 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.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit 1) or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine).
* Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth was acceptable.
* Receipt of immune globulins, blood or blood-derived since birth.
* Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
* History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy.
* History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
* History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease.
* 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).
* History of Guillain-Barré syndrome.
* 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 neomycin, kanamycin, polymyxin, formaldehyde, and latex.
* Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
* History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception.
* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator's opinion.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.
* Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study.
* Moderate or severe acute illness/infection (according to investigator judgment), or febrile illness (temperature \>= 38.0°C), or diarrhea or vomiting on the day of vaccination. A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided.
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
56 Days
Maximum Age:
89 Days
Study:
NCT03632720
Study Brief:
Protocol Section:
NCT03632720