Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US

Completed · Phase 3

Conditions studied: Healthy Volunteers (Meningococcal Infection)

In brief

The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers in the US.

Key facts

Study ID

NCT03537508

Run by

Sanofi Pasteur, a Sanofi Company

People needed

2627

Starts

2018-04-25

Expected to finish

2023-09-22

Last updated by the study team

2024-10-15

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 an independent witness, if required by local regulations
• Participant and parent/guardian were 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

You may not qualify if…

• 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 could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included 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 of 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; and of Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or 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 travelling to countries with high endemic or epidemic disease)
• History of intussusception
• History of any neurologic disorders, including any 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
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
• 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, was at a stage where it might have interfered with trial conduct or completion
• Any condition which, in the opinion of the investigator, might have interfered 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 ≥ 38.0°C [≥ 100.4°F]). A prospective participant was not included in the study until the condition has been resolved or the febrile event has been 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 patient's potential participation in a clinical trial.

Where it is running

• Southeastern Pediatric Associates Site Number : 8400003 — Dothan, Alabama, United States
• MedPharmics, LLC - Phoenix Site Number : 8400083 — Phoenix, Arizona, United States
• Northwest Arkansas Pediatric Clinic Site Number : 8400011 — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro, PA Site Number : 8400032 — Jonesboro, Arkansas, United States
• Emmaus Research Center, Inc Site Number : 8400031 — Anaheim, California, United States
• Premier Health Research Center Site Number : 8400007 — Downey, California, United States
• Joint Clinical Trials Huntington Park Site Number : 8400126 — Huntington Park, California, United States
• United Clinical Research Site Number : 8400092 — Huntington Park, California, United States
• Matrix Clinical Research Site Number : 8400095 — Los Angeles, California, United States
• Center for Clinical Trials, LLC Site Number : 8400030 — Paramount, California, United States
• Center for Clinical Trials of San Gabriel Site Number : 8400076 — West Covina, California, United States
• Asclepes Research Centers Site Number : 8400064 — Brooksville, Florida, United States
• Avail Clinical Research Site Number : 8400077 — DeLand, Florida, United States
• Next Phase Research Alliance Site Number : 8400057 — Hialeah, Florida, United States
• Homestead Medical Clinic, P.A. Site Number : 8400014 — Homestead, Florida, United States
• Next Phase Research Alliance Site Number : 8400040 — Homestead, Florida, United States
• Children's Research, LLC Site Number : 8400063 — Lake Mary, Florida, United States
• Axcess Medical Research Site Number : 8400068 — Loxahatchee Groves, Florida, United States
• Acevedo Clinical Research Associates Site Number : 8400001 — Miami, Florida, United States
• Florida Hospital Medical Group Pediatrics Site Number : 8400108 — Orlando, Florida, United States
• IMIC Inc Site Number : 8400022 — Palmetto Bay, Florida, United States
• Jedidiah Clinical Research Site Number : 8400132 — Tampa, Florida, United States
• Baybol Research Institute Site Number : 8400008 — Chamblee, Georgia, United States
• Snake River Research, PLLC Site Number : 8400073 — Idaho Falls, Idaho, United States
• Birmingham Pediatric Associates Site Number : 8400026 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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