AzTrials
AzTrials

Meningococcal InfectionsPhase 3NCT03547271

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

A Phase 3 study testing MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine and DTaP-IPV-HB-Hib vaccine in people with Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 33 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was given… Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
Conditions the study is for
Meningococcal Infections
What is being tested?
MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine and DTaP-IPV-HB-Hib vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,660 participants
Where
33 sitesin 7 countries
Study dates
14 Dec 2018to 24 May 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 42 to 89 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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
  • Subject and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all study procedures
  • Covered by health insurance according to local regulations

Who cannot join

  • Participated at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Received 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 included monovalent pandemic influenza vaccines and multivalent influenza vaccines. This exclusion criterion did not apply to subjects in Finland, Sweden or Poland who planned to receive the licensed rotavirus vaccine concomitantly with study vaccines at study vaccination visits V1 and V2.
  • Received 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.
  • Received immune globulins, blood or blood-derived products since birth
  • Known or suspected congenital or acquired immunodeficiency; or received 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
Show all 23Show fewer
  • Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
  • Individuals that had blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
  • Individuals that had 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
  • Individuals that were at high risk for meningococcal infection during the study (specifically, but not limited to, subjects that had persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
  • Individuals that had 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-Barré 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
  • Reported of thrombocytopenia, contraindicating intramuscular vaccination in the investigator's opinion
  • Bleeding disorder, or received 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, were at a stage where it could interfere with study conduct or completion
  • Any condition which, in the opinion of the investigator, could interfere with the evaluation of the study objectives, including planned 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 ≥ 38.0°C). A prospective subject could not be included in the study until the condition was resolved or the febrile event was subsided.
  • Received 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) required specific immunization schedule for routine childhood vaccines and/or specific care at the time of vaccination, as per national recommendations

Trial locations and contacts

33 sites in 7 countries.

33 sites in 7 countries

Finland10 sites

  • Investigational Site Number : 2462007

    Espoo, 02230

  • Investigational Site Number : 2462003

    Helsinki, 00100

  • Investigational Site Number : 2462004

    Helsinki, 00930

  • Investigational Site Number : 2462001

    Jarvenpaa, 04400

  • Investigational Site Number : 2462006

    Kokkola, 67100

  • Investigational Site Number : 2462005

    Oulu, 90220

  • Investigational Site Number : 2462002

    Pori, 28100

  • Investigational Site Number : 2462009

    Seinäjoki, 60100

  • Investigational Site Number : 2462010

    Tampere, 33100

  • Investigational Site Number : 2462008

    Turku, 20520

Other trials in Finland

Czechia9 sites

  • Investigational Site Number : 2031006

    Chlumec nad Cidlinou, 503 51

  • Investigational Site Number : 2031013

    Domažlice, 34401

  • Investigational Site Number : 2031010

    Jindřichův Hradec, 377 01

  • Investigational Site Number : 2031012

    Jindřichův Hradec, 377 01

  • Investigational Site Number : 2031003

    Ostrava, 702 00

  • Investigational Site Number : 2031008

    Ostrava-hrabuvka, 700 30

  • Investigational Site Number : 2031009

    Pardubice, 530 09

  • Investigational Site Number : 2031005

    Pardubice, 530 12

  • Investigational Site Number : 2031007

    Smiřice, 503 03

Other trials in Czechia

Poland4 sites

  • Investigational Site Number : 6167002

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-090

  • Investigational Site Number : 6167003

    Siemianowice Śląskie, 41-103

  • Investigational Site Number : 6167006

    Torun, 87-100

  • Investigational Site Number : 6167004

    Trzebnica, Lower Silesian Voivodeship, 55-100

Other trials in Poland

Romania4 sites

  • Investigational Site Number : 6424003

    Brasov, 500063

  • Investigational Site Number : 6424001

    Bucaresti, 21105

  • Investigational Site Number : 6424002

    Calarasi, 910160

  • Investigational Site Number : 6424006

    Caracal, 235200

Other trials in Romania

Spain4 sites

  • Investigational Site Number : 7245003

    Madrid, Madrid, Comunidad de, 28007

  • Investigational Site Number : 7245002

    Madrid, 28046

  • Investigational Site Number : 7245001

    Santiago de Compostela, 15706

  • Investigational Site Number : 7245006

    Seville, 41014

Other trials in Spain

Italy1 site

  • Investigational Site Number : 3803002

    Milan, 20122

Other trials in Italy

Sweden1 site

  • Investigational Site Number : 7526001

    Umeå, 901 87

Other trials in Sweden

About this study

Official title: Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe

Primary objective:

This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine was 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

Read more

Secondary objectives:

This study aimed to demonstrate the non-inferiority of the antibody (Ab) 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 was 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.

  • This study aimed to describe the Ab responses against meningococcal groups A, C, Y, and W and the antigens of the routine pediatric vaccines administered in the study.
Being tested
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)
Keywords
Meningococcal meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Medical subject headings
Meningococcal Infections, Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenACYW conjugate vaccineBiological

    Also called MenQuadfi®

    Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, 0.5 mL, intramuscular

  • Meningococcal group A, C, W-135, and Y conjugate vaccineBiological

    Also called Nimenrix®

    Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular

  • DTaP-IPV-HB-Hib vaccineBiological

    Also called Hexyon®/Hexacima®

    Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

  • Pneumococcal vaccine (13-valent)Biological

    Also called Prevenar 13®

    Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

  • Pneumococcal vaccine (10-valent)Biological

    Also called Synflorix®

    Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)

  • MMR vaccineBiological

    Also called M-M-RVAXPRO®

    Measles, mumps, and rubella vaccine

Study groups in NCT03547271
Study groupRoleWhat they receive
Group 1: MenACYWExperimentalParticipants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid [MenACYW conjugate vaccine] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine [DTaP-IPV-HB-Hib], the pneumococcal vaccine (pneumococcal conjugate vaccine [10-valent, adsorbed] {PCV10} were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA.
Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV-HB-Hib vaccine; Biological: Pneumococcal vaccine (10-valent); Biological: MMR vaccine
Group 2: NimenrixActive comparatorParticipants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.
Receives: Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine; Biological: DTaP-IPV-HB-Hib vaccine; Biological: Pneumococcal vaccine (10-valent); Biological: MMR vaccine
Group 3: MenACYWExperimentalParticipants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) [PCV13] were administered in a 2+1 regimen (ie, 2 doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and 1 final dose in the second year of life [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA.
Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV-HB-Hib vaccine; Biological: Pneumococcal vaccine (13-valent); Biological: MMR vaccine
Group 4: MenACYWExperimentalParticipants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy [first between 6 and 12 weeks of age and second between 4 to 5 MoA] and the toddler dose of MenACYW conjugate vaccine [12 to 18 MoA]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines.
Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV-HB-Hib vaccine; Biological: Pneumococcal vaccine (13-valent); Biological: MMR vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).

    Measured: At 30 days post Dose 3 [12 to 18 months of age (MoA)]

Secondary outcomes (17)

  1. Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Measured: At 30 days post Dose 2 (4 MoA)

  2. Groups 3 and 4: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA.

    Measured: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)

  3. Groups 1 and 2: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Measured: Day 0 Before Dose 1 (2 MoA) and Day 30 Post Dose 2 (4 MoA); Day 0 Before Dose 3 (12 to 18 MoA) and Day 30 Post Dose 3 (12 to 18 MoA)

  4. Groups 3 and 4: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:4 and >=1:8

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.

    Measured: Group 3: Day 0 before Dose 1 (2 MoA) and Dose 3 (12 to 18 MoA) and Day 30 Post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: Day 0 before Dose 1 (2 MoA) and Dose 4 (12 to 18 MoA) and Day 30 Post Dose 3 (6 MoA) and Dose 4 (12 to 18 MoA)

  5. Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer <1:8, the post-vaccination titer must be >=1:16 and for a participant with a pre vaccination titer >=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA)

  6. Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse

    Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre vaccination titer <1:8, the post-vaccination titer must be >=1:16 and for a participant with a pre vaccination titer >=1:8, the post-vaccination titer must be at least 4-fold greater than the pre vaccination titer. Percentages are rounded off to the tenth decimal place.

    Measured: Group 3: Day 30 Post Dose 2 (4 MoA), Day 30 Post Dose 3 (12 to 18 MoA); Group 4: D30 Post Dose 3 (6 MoA), Day 30 Post Dose 4 (12 to 18 MoA)

  7. Geometric Mean Concentrations (GMCs) of Anti-Pertussis Antibodies

    GMCs of anti-pertussis antibodies (pertussis toxin [PT], filamentous hemagglutinin [FHA]) were measured by electrochemiluminescent (ECL) assay.

    Measured: Groups 1, 2 and 3: Day 0 before Dose 1 (2 MoA); Group 4: Day 0 before Dose 4 (12 to 18 MoA)

  8. Geometric Mean Concentrations (GMCs) of Hexavalent Vaccines

    GMCs of hexavalent vaccines were measured as: anti-diphtheria, anti-tetanus, anti-pertussis antibodies (PT, FHA) by ECL assay, anti-hepatitis antibodies (anti-Hepatitis B surface antigen [HBsAg]) by the commercially available VITROS ECi/ECiQ, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-polyribosylribitol phosphate [PRP]) by Farr-type radioimmunoassay (RIA).

    Measured: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  9. Percentage of Participants With Response Rate for Anti-Diphtheria, Anti-Tetanus, Anti-Poliovirus Types 1, 2, and 3, Anti-Haemophilus Influenzae Type b (Anti-PRP)

    GMCs of anti-diphtheria, anti-tetanus, anti-poliovirus types 1, 2, and 3, anti-haemophilus influenzae type b (anti-PRP) vaccines were measured as: anti-diphtheria, anti-tetanus by ECL assay, anti-poliovirus types 1, 2, and 3 by neutralization assay and anti-Haemophilus influenzae type b (anti-PRP) by Farr-type RIA. Response rate was defined as percentage of participants who achieved: anti diphtheria and anti-tetanus antibody concentrations >=0.01 international units (IU)/milliliter (mL), >=0.1 IU/mL and >=1.0 IU/mL; anti-poliovirus types 1, 2, and 3 antibody titers >=1:8; anti-PRP antibody concentrations >=0.15 microgram (mcg)/mL and >=1 mcg/mL. Percentages are rounded off to the tenth decimal place.

    Measured: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  10. Percentage of Participants Who Achieved Vaccine Seroresponse for Anti-Pertussis Antibodies

    GMCs of anti-pertussis antibodies (PT, FHA) were measured by ECL assay. The pertussis vaccine seroresponse for anti-PT and anti-FHA was defined as: For groups 1, 2, and 3, 30 days after dose 2 in infancy as if the pre-primary vaccination concentration is <4 × lower limit of quantification (LLOQ), post-primary vaccination concentration >=4 × LLOQ, if the pre-primary vaccination concentration is >=4 ×LLOQ, post-primary vaccination concentration >=pre-primary vaccination concentration; and for Groups 1, 2, and 3, before and 30 days after the dose 3 and for group 4, before and 30 days after the dose 4 as if the pre-booster vaccination concentration is <4 × LLOQ, post-booster vaccination concentration >=4 × pre-booster concentration, if the pre-booster vaccination concentration is >=4 × LLOQ, post-booster vaccination concentration >=2 × pre-booster concentration. Percentages are rounded off to the tenth decimal place.

    Measured: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  11. Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 and >=100 Milli-International Units (mIU)/mL

    GMCs of anti-hepatitis antibodies (anti-HBsAg) was measured by the commercially available VITROS ECi/ECiQ. Response rate for anti-HBsAg was defined as percentage of participants who achieved anti-HBsAg antibody concentrations >=10 mIU/mL and >=100 mIU/mL. Percentages are rounded off to the tenth decimal place.

    Measured: Groups 1, 2 and 3: Day 30 Post Doses 2 and 3 (4 MoA and 12 to 18 MoA); Day 0 Before Dose 3 (12 to 18 MoA); Group 4: Day 30 Post Dose 4 (12 to 18 MoA)

  12. Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) (PCV10) Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) Immunoglobulin G (IgG) ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum.

    Measured: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

  13. Groups 3 and 4: Geometric Mean Concentrations (GMCs) of Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) (PCV13) Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum.

    Measured: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  14. Groups 1 and 2: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (10-Valent, Adsorbed) PCV10 Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

    Measured: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA)

  15. Groups 3 and 4: Percentage of Participants With Response Rate >=0.35 mcg/mL for Pneumococcal Conjugate Vaccine (13-Valent, Adsorbed) PCV13 Vaccine

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which was used to quantitate the amount of anti-streptococcus pneumoniae PS (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) antibodies in human serum. Percentages are rounded off to the tenth decimal place.

    Measured: Group 3: At 30 days post Dose 2 (4 MoA) and Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  16. Geometric Mean Concentrations (GMCs) of Anti-Measles, Mumps and Rubella (MMR) Antibodies

    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG enzyme immunoassay (EIA) and anti-mumps antibodies were assessed by enzyme-linked immunosorbent assay (ELISA).

    Measured: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

  17. Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies

    GMCs of anti-measles and anti-rubella antibodies were measured by bulk IgG EIA and anti-mumps antibodies were assessed by ELISA. Vaccine response against anti-measles, anti-mumps, anti-rubella antibodies were defined as percentage of participants with anti-measles, anti-mumps, anti-rubella antibody concentration that met the respective mentioned criterion: measles: >=255 mIU/mL; mumps: >=10 mumps antibody units/mL and rubella: >=10 IU/mL. Percentages are rounded off to the tenth decimal place.

    Measured: Groups 1, 2 and 3: At 30 days post Dose 3 (12 to 18 MoA); Group 4: At 30 days post Dose 4 (12 to 18 MoA)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2018
  2. Study start14 Dec 2018
  3. Primary completion17 May 2023
  4. Study completion24 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03547271
Sponsor's protocol ID
MET58
Other IDs
U1111-1183-6653, MET58, 2017-004731-36, 2017
Status last verified
Feb 2025
First submitted
24 May 2018
Last updated
3 Mar 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Martinon-Torres F, Virta MM, Koski S, de la Cueva IS, Szymanski HT, Bosis S, Draganescu AC, Silfverdal SA, Zambrano B, Dhingra MS, B'Chir S, Syrkina O, Lyabis O, Vasquez GA, Rehm C; MET58 Study Group. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial. Infect Dis Ther. 2025 Aug;14(8):1843-1865. doi: 10.1007/s40121-025-01190-7. Epub 2025 Jul 15.

    PubMed 40665158

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine and DTaP-IPV-HB-Hib vaccine in people with Meningococcal Infections, run by Sanofi Pasteur, a Sanofi Company at 33 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Finland, Czechia, Poland, Romania, Spain and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Groups 1 and 2: Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, W, and Y (time frame: At 30 days post Dose 3 [12 to 18 months of age (MoA)]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03547271, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.

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