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

  • STATUS
    Recruiting
  • End date
    May 28, 2024
  • participants needed
    940
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 29 November 2020
Investigator
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Summary

The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.

The secondary objective is to demonstrate the non-inferiority of the percentage of subjects with antibody titers to meningococcal serogroups A, C, Y, and W 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.

The study also includes as an observational objective 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 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination.

Details
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, Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine, Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine, Haemophilus b Conjugate Vaccine, Rotavirus Vaccine, Live, Oral, Pentavalent, Measles, Mumps, and Rubella Virus Vaccine Live, Varicella Virus Vaccine Live
Clinical Study IdentifierNCT03691610
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on29 November 2020

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Eligibility

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Inclusion Criteria

Is your age between 1 yrs and 1 yrs?
Gender: Male or Female
Do you have any of these conditions: or Pediatric Health or Brain Function or Metastatic Triple-Negative Breast Cancer or Recurrent Respiratory Papillomatosis or Chronic Shoulder Pain or...?
Do you have any of these conditions: or Injection Port or Brain Function or Chronic Diarrhea or Anal Dysplasia or Peripheral Arterial Occlusive Disease or Near-Sighted Corrective Surgery...?
Do you have any of these conditions: or Pediatric Health or Near-Sighted Corrective Surgery or Skin Wounds or Chronic Diarrhea or Chronic Shoulder Pain or Razor Bumps (Pseudofolliculitis...?
Aged 6 to 7 months (164 to 224 days) or 17 to 19 months on the day of the first visit
Born at full term of pregnancy ( 37 weeks) and with a birth weight 2.5 kg
Informed consent form has been signed and dated by the parent(s) or other 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
For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment

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, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine) or rotavirus vaccine
For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the rotavirus vaccine at 2 and 4 months of age
Receipt of immune globulins, blood, or blood-derived products in the past 3 months
Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
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 Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
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 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 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 [ 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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