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

  • STATUS
    Recruiting
  • End date
    Aug 14, 2023
  • participants needed
    2475
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 14 June 2021
Investigator
For site information, send an email with site number to
Primary Contact
Investigational Site Number 8400011 (1.2 mi away) Contact
+83 other location
hepatitis b
dtap
pneumococcal
rotavirus
measles
rubella
mumps
hib vaccine
conjugate vaccine
hepatitis a vaccine
meningococcal conjugate
varicella vaccine
menveo

Summary

The purpose of this study is 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.

Primary objectives:

  • To demonstrate the non-inferiority of the immune response after a 4-dose series of MenACYW conjugate vaccine compared to a 4-dose series of MENVEO when given concomitantly with routine pediatric vaccines to infants and toddlers 6 weeks to 15 months of age.
  • To demonstrate the non-inferiority of the immune response after 3 doses of MenACYW conjugate vaccine compared to 3 doses of MENVEO when given concomitantly with routine pediatric vaccines to infants at 2, 4, and 6 months of age.

Secondary objective:

  • To demonstrate the non-inferiority of the immune responses of the routine pediatric vaccines administered concomitantly with MenACYW conjugate vaccine as compared with MENVEO to infants and toddlers 6 weeks to 18 months of age.
  • To assess the antibody responses against meningococcal serogroups A, C, Y, and W after the administration of the 4th dose of MenACYW conjugate vaccine as compared with MENVEO when both are given concomitantly with routine pediatric vaccines at 12 months of age.
  • To assess the persistence of bactericidal antibodies at 12 months of age (prior to the 4th dose) in participants who previously received 3 doses of MenACYW conjugate vaccine or MENVEO in infancy concomitantly with routine pediatric vaccines at 2, 4, and 6 months of age.

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

Healthy infants will be enrolled and randomized to receive either 4 doses of MenACYW conjugate vaccine or 4 doses of the licensed control vaccine, MENVEO. All participants will receive routine vaccines as per the Advisory Committee on Immunization Practices (ACIP) recommendations.

All participants will be assessed for immunogenicity at baseline (pre-vaccination), and after completing the infant schedule and the second year of life vaccination schedule.

Safety will be assessed throughout the study period, and includes solicited injection site and systemic reactions as well as unsolicited adverse events after each vaccine injection, and serious adverse events occurring throughout the trial.

Details
Condition Meningococcal infection, meningococcal infections, meningococcal disease
Treatment Hepatitis B vaccine, Hepatitis A vaccine, Pneumococcal 13-valent Conjugate Vaccine, Varicella Vaccine, MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine, Pentavalent rotavirus vaccine, Measles, mumps, rubella (MMR) vaccine
Clinical Study IdentifierNCT03537508
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on14 June 2021

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 an independent witness, if required by local regulations
Participant 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 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 (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-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 (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 38.0C [ 100.4F]). 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
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