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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Healthy Volunteers (Meningococcal Infection)

Treatments: Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: MenACYW conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: DTaP-IPV//Hib vaccine; Biological: Hepatitis A vaccine; Biological: Varicella vaccine; Biological: MenACYW-135 conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03537508

2018-001473-24 (EudraCT Number)

U1111-1183-6361 (Registry Identifier)

MET42

Details and patient eligibility

About

The purpose of this study was 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.

Full description

The duration of each subject's participation in the trial was approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which included a safety follow up contact at 6 months after the last vaccinations.

Enrollment: 2,627 patients

Sex: All

Ages: 42 to 89 days old

Volunteers: Accepts Healthy Volunteers

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 were 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 could have been received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception included 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-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
• 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, was at a stage where it might have interfered with trial conduct or completion
• Any condition which, in the opinion of the investigator, might have interfered 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 participant was not included in the study until the condition has been resolved or the febrile event has been subsided
• Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study
• The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,627 participants in 4 patient groups

Group 1a

Experimental group

Description:

MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age

Treatment:

Biological: Varicella vaccine

Biological: DTaP-IPV//Hib vaccine

Biological: Hepatitis B vaccine

Biological: Pentavalent rotavirus vaccine

Biological: MenACYW conjugate vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: Measles, mumps, rubella (MMR) vaccine

Group 1b

Experimental group

Description:

MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age

Treatment:

Biological: Varicella vaccine

Biological: Hepatitis A vaccine

Biological: DTaP-IPV//Hib vaccine

Biological: Hepatitis B vaccine

Biological: Pentavalent rotavirus vaccine

Biological: MenACYW conjugate vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: Measles, mumps, rubella (MMR) vaccine

Group 2a

Active Comparator group

Description:

MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age

Treatment:

Biological: MenACYW-135 conjugate vaccine

Biological: Varicella vaccine

Biological: DTaP-IPV//Hib vaccine

Biological: Hepatitis B vaccine

Biological: Pentavalent rotavirus vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: Measles, mumps, rubella (MMR) vaccine

Group 2b

Active Comparator group

Description:

MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age

Treatment:

Biological: MenACYW-135 conjugate vaccine

Biological: Varicella vaccine

Biological: Hepatitis A vaccine

Biological: DTaP-IPV//Hib vaccine

Biological: Hepatitis B vaccine

Biological: Pentavalent rotavirus vaccine

Biological: Pneumococcal 13-valent conjugate vaccine

Biological: Measles, mumps, rubella (MMR) vaccine