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

  • STATUS
    Recruiting
  • participants needed
    525
  • sponsor
    Sanofi Pasteur, a Sanofi Company
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Updated on 8 December 2020
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Summary

Primary Objective:

  1. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and
  2. present in MenACYW conjugate vaccine or Menveo measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
  3. To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and
  4. present in MenACYW conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation

Secondary Objective:

  1. To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Groups 1 and 2, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
  2. To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Group 3, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation

Description

Study duration per participant is approximately 12 months

Details
Condition Healthy Volunteers
Age 1years - 1years
Treatment Measles, Mumps, and Rubella Virus Vaccine Live, Hepatitis B vaccine, Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Pneumococcal 13-valent Conjugate Vaccine, Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine, Rotavirus Vaccine, Live, Pentavalent, Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Clinical Study IdentifierNCT03630705
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on8 December 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be
eligible for trial
enrollment
Infants 2 months of age (60 to 89 days of age) on the day of the first study visit
Born after a full-term pregnancy, with an estimated gestation age 37 weeks and a birth weight 2.5 kg
Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
In good health as determined by medical history and physical assessment
For the Russian Federation: The subject's parents are able to verbally report or provide written documentation that the subject's mother was hepatitis B antigennegative during pregnancy with the subject
2 months" means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); "60 days" means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days)
In the Russian Federation, as per local regulations, only the subject's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian will not be included in the study

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from
trial
enrollment
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 a gap of 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 (ie, meningitis polysaccharide or meningitis conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella
For Mexico: 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, 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 (febrile and non-febrile) and progressive neurologic disorders
History of Guillain-Barr syndrome
Known systemic hypersensitivity to any of the vaccine components or to latex, 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, 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 of the first blood draw
Chronic illness 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 38.0 C). 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
For the Russian Federation, febrile illness is defined as temperature 37 C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
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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