Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

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Recruiting
participants needed

1540
sponsor

Sanofi Pasteur, a Sanofi Company

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Updated on 19 February 2024

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diabetes

antibiotics

antibiotic therapy

vaccination

chronic disease

pneumococcal

conjugate vaccine

pertussis

diphtheria

hib vaccine

tetanus

antibody response

poliomyelitis

dtap

hepatitis b

haemophilus

acute illness

meningococcal conjugate

meningococcal vaccine

immunization schedule

febrile illness

whooping cough

influenzae

genetic diseases

meningococcal

renal disorders

disorders, congenital

Summary

The primary objective of the study is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old.

The secondary objectives are:

To demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.
To describe the antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered in a 3-dose series concomitantly with the routine pediatric vaccines.
To describe the antibody responses against the antigens of the routine pediatric vaccines administered in a 3-dose series concomitantly with MenACYW conjugate vaccine or a licensed meningococcal vaccine.
To describe the safety profile of MenACYW conjugate vaccine and a licensed meningococcal vaccine.

Description

Healthy infants and toddlers will receive MenACYW conjugate vaccine or a licensed meningococcal vaccine, and routine pediatric vaccines.

All participants will be assessed for immunogenicity before and after vaccination.

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 study.

Details

Condition	Meningococcal infection, meningococcal infections
Age	1-1 years
Treatment	MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine, Pneumococcal vaccine (13-valent), Pneumococcal vaccine (10-valent), MMR vaccine
Clinical Study Identifier	NCT03547271
Sponsor	Sanofi Pasteur, a Sanofi Company
Last Modified on	19 February 2024

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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 other legally acceptable representative (and by an independent witness if required by local regulations)
	Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
	Covered by health insurance according to local regulations
Exclusion Criteria
	Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
	Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. This exclusion criterion does not apply to subjects in Finland or Sweden who plan to receive the licensed rotavirus vaccine during study vaccination visits
	Receipt or planned to receipt during the study period vaccination against meningococcal disease with either the study 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)
	Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella. Previous vaccination against hepatitis B when administered to risk groups, as per local recommendation
	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, unless 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 Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
	History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease
	At high risk for meningococcal infection during the study (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)
	Individuals with underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus [HIV] infection)
	History of any neurologic disorders, including seizures and progressive neurologic disorders
	History of Guillain-Barr syndrome
	Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin
	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 study conduct or completion
	Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
	Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature 38.0C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
	Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
	Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
	Infants born preterm (by less than 37 weeks of gestation) requiring specific immunization schedule for routine childhood vaccines and/or specific care at the time of vaccination, as per national recommendations

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Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe