Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers
- Conditions
- Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2019-004459-35-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 2797
- Aged = 42 to = 89 days on the day of the first study visit.
- Healthy infants as determined by medical history, physical examination, and judgment of the investigator.
- Informed consent form has been signed and dated by the parent(s) or guardian (and by an independent witness if required by local regulations).
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
- Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit
Are the trial subjects under 18? yes
Number of subjects for this age range: 3080
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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 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 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 disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, PS, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- 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.
- Receipt of more than 1 previous dose of hepatitis B vaccine.
- Receipt of immune globulins, blood or blood-derived products since birth.
- Known or suspected congenital or acquired immunodeficiency; 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.
- Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with active tuberculosis
- History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection/disease.
- At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease).
- History of intussusception.
- History of any neurologic disorders, including seizures and progressive neurologic disorders.
- History of Guillain-Barré syndrome.
- Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a lifethreatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast .
- 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 in the Investigator's opinion.
- Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that in the opinion of the investigator, is at a stage where it might interfere with trial conduct o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To describe the safety profile of MenACYW conjugate vaccine and MENVEO® when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers ;Secondary Objective: Not applicable;Primary end point(s): 1- Solicited injection site reactions and systemic reactions ; Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability <br>2- Participant with immediate adverse events ; Immediate adverse events are unsolicited systemic adverse events occuring in the 30 minutes after injection <br>3- Participant with unsolicited adverse events ; Unsolicited adverse events are adverse events other than solicited reactions ;Timepoint(s) of evaluation of this end point: 1 : Within 7 days after any injection <br>2 : Within 30 minutes after any injection <br>3 : Within 30 days after any injection
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1- Participant with serious adverse events : Serious adverse events are collected throughout the study <br>2- Participant with medically attended adverse events : Medically attended adverse events are collected throughout the study;Timepoint(s) of evaluation of this end point: 1,2 : From Day 0 to Month 6