Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers (MET41)

  • STATUS
    Recruiting
  • End date
    Mar 24, 2023
  • participants needed
    3080
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 24 July 2022
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Accepts healthy volunteers

Summary

The primary objective of this study is to describe the safety profile of MenACYW conjugate vaccine and MENVEO® when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers

Description

Study duration per participant is approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination

Details
Condition Healthy Volunteers (Meningococcal Infection)
Treatment Hepatitis B vaccine, Pneumococcal 13-valent Conjugate Vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine, Rotavirus Vaccine, Rotavirus Vaccine, Measles, Mumps, and Rubella Virus Vaccine, Varicella Virus Vaccine, Varicella Virus Vaccine
Clinical Study IdentifierNCT03673462
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on24 July 2022

Eligibility

 Yes No Not Sure

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 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

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 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 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 C [≥ 100.4 F]). A prospective subject 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 is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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