Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (MET41)
Status and phase
Completed
Phase 3
Conditions
Healthy Volunteers (Meningococcal Infection)
Treatments
Biological: Rotavirus Vaccine
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)
Biological: Hepatitis B Vaccine
Biological: Varicella Virus Vaccine
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
Biological: Measles, Mumps, and Rubella Virus Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.
Full description
Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.
Enrollment
2,797 patients
Sex
All
Ages
42 to 89 days old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 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 was signed and dated by the parent(s) or guardian (and by an independent witness if required by local regulations).
- Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.
- Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit.
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 or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which might 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, polysaccharide, 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 was 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, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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 life-threatening 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 or completion.
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38 degree Celsius [>= 100.4-degree Fahrenheit]). A prospective participant should not be included in the study until the condition has 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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial design
Primary purpose
Prevention
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
2,797 participants in 2 patient groups
Group 1: MenACYW Conjugate Vaccine
Experimental group
Description:
Healthy infants aged greater than equal to (\>=) 42 to less than equal to (\<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Treatment:
Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
Biological: Rotavirus Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Hepatitis B Vaccine
Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Biological: Varicella Virus Vaccine
Group 2: MENVEO®
Active Comparator group
Description:
Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Treatment:
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)
Biological: Rotavirus Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Hepatitis B Vaccine
Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Biological: Varicella Virus Vaccine
Trial contacts and locations
68
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Data sourced from clinicaltrials.gov
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