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 (MET33)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Healthy Volunteers (Meningococcal Infection)

Treatments

Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
Biological: Rotavirus Vaccine, Live, Pentavalent
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Hepatitis B Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03630705
MET33
U1111-1183-6409 (Other Identifier)

Details and patient eligibility

About

Primary Objective: To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) 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. To describe the vaccine seroprotection (antibody titer >=1:8) to the antigens (meningococcal serogroups A, C, Y, and W) 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: To describe hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) 30 days after the last vaccination of the infant series, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico and Russian Federation (RF). To describe immunogenicity profile of routine pediatric vaccines when administered concomitantly with MenACYW Conjugate vaccine or Menveo®; or when administered alone. To describe hSBA antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW Conjugate vaccine and Menveo® are administered concomitantly with routine pediatric vaccines in Mexico and RF. To describe antibody titers to the antigens present in MenACYW Conjugate vaccine and Menveo®, before the first vaccination and 30 days after the last vaccination of the infant series and in the second year of life, when administered concomitantly with routine pediatric vaccines in a subset of participants in Mexico and RF.

Full description

Study duration per participant was approximately 12 months.

Enrollment

525 patients

Sex

All

Ages

2 to 12 months old

Volunteers

Accepts Healthy Volunteers

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 kilograms.
  • Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
  • Participant and parent/guardian were 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 participant's parents were able to verbally report or provide written documentation that the participant's mother was hepatitis B antigen negative during pregnancy with the participant.

* "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 participant's parent(s) were entitled to sign an informed consent form. A child under the responsibility of a guardian would not be included in the study.

Exclusion criteria

An individual fulfilling any of the following criteria was 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 (i.e., 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, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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-Barré 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 degree Celsius [°C]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had 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 was defined as temperature >= 37°C. A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

525 participants in 4 patient groups

Group 1: MenACYW Conjugate Vaccine (Mexico)
Experimental group
Description:
Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12.
Treatment:
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Biological: Rotavirus Vaccine, Live, Pentavalent
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Group 2: Menveo® (Mexico)
Active Comparator group
Description:
Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12.
Treatment:
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine
Biological: Rotavirus Vaccine, Live, Pentavalent
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Group 3: MenACYW Conjugate Vaccine (Russian Federation)
Experimental group
Description:
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Treatment:
Biological: Hepatitis B Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live
Group 4: Routine Pediatric Vaccines (Russian Federation)
Other group
Description:
Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12.
Treatment:
Biological: Hepatitis B Vaccine
Biological: Pneumococcal 13-valent Conjugate Vaccine
Biological: Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine
Biological: Measles, Mumps, and Rubella Virus Vaccine Live

Trial documents
2

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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