AzTrials
AzTrials

Healthy Volunteers (Meningococcal Infection)Phase 3NCT03537508

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

A Phase 3 study testing MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine and DTaP-IPV//Hib vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 70 sites in 2 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

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. Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
What is being tested?
MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine and DTaP-IPV//Hib vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,627 participants
Where
70 sitesin 2 countries
Study dates
25 Apr 2018to 22 Sep 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 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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 locations and contacts

70 sites in 2 countries.

70 sites in 2 countries

United States65 sites

  • Emmaus Research Center, Inc Site Number : 8400031

    Anaheim, California, 92804

  • ARC Clinical Research at Wilson Parke Site Number : 8400059

    Austin, Texas, 78726

  • MedPharmics Biloxi Site Number : 8400080

    Biloxi, Mississippi, 39531

  • Birmingham Pediatric Associates Site Number : 8400026

    Birmingham, Alabama, 35205

  • Blue Pediatric & Adolescent Medicine Group Site Number : 8400100

    Boone, North Carolina, 28607

  • Craig Spiegel, MD Site Number : 8400037

    Bridgeton, Missouri, 63044

  • Asclepes Research Centers Site Number : 8400064

    Brooksville, Florida, 34613

  • Baybol Research Institute Site Number : 8400008

    Chamblee, Georgia, 30341

  • Coastal Pediatric Research Charleston Site Number : 8400005

    Charleston, South Carolina, 29414

  • Ericksen Research and Development Site Number : 8400016

    Clinton, Utah, 84015

  • Oak Cliff Research Company, LLC Site Number : 8400065

    Dallas, Texas, 75218

  • Ohio Pediatric Research Site Number : 8400084

    Dayton, Ohio, 45414

  • PriMed Clinical Research Site Number : 8400002

    Dayton, Ohio, 454429

  • Avail Clinical Research Site Number : 8400077

    DeLand, Florida, 32720

  • Southeastern Pediatric Associates Site Number : 8400003

    Dothan, Alabama, 36305

  • Premier Health Research Center Site Number : 8400007

    Downey, California, 90241

  • Allegheny Health and Wellness Pavilion Site Number : 8400047

    Erie, Pennsylvania, 16505

  • Qualmedica Research, LLC Site Number : 8400106

    Evansville, Indiana, 47715

  • Northwest Arkansas Pediatric Clinic Site Number : 8400011

    Fayetteville, Arkansas, 72703

  • Helios Clinical research Site Number : 8400075

    Fort Worth, Texas, 76104

  • University of North Texas Site Number : 8400079

    Fort Worth, Texas, 76107-2699

  • University of Maryland at The Pediatric Center of Frederick Site Number : 8400004

    Frederick, Maryland, 21702

  • University of Texas Medical Board Site Number : 8400067

    Galveston, Texas, 77555-0163

  • Tribe Clinical Research Site Number : 8400110

    Greenville, South Carolina, 29607

  • Cyn3rgy Research Site Number : 8400085

    Gresham, Oregon, 97030

  • ACC Pediatric Reasearch Site Number : 8400023

    Haughton, Louisiana, 71037

  • Next Phase Research Alliance Site Number : 8400057

    Hialeah, Florida, 33013

  • Homestead Medical Clinic, P.A. Site Number : 8400014

    Homestead, Florida, 33030

  • Next Phase Research Alliance Site Number : 8400040

    Homestead, Florida, 33030

  • Helios Clinical Research Site Number : 8400109

    Houston, Texas, 77008

  • Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400114

    Houston, Texas, 77074-2085

  • Marshall Health Site Number : 8400062

    Huntington, West Virginia, 25701

  • Joint Clinical Trials Huntington Park Site Number : 8400126

    Huntington Park, California, 90255

  • United Clinical Research Site Number : 8400092

    Huntington Park, California, 90255

  • Snake River Research, PLLC Site Number : 8400073

    Idaho Falls, Idaho, 83404

  • The Children's Clinic of Jonesboro, PA Site Number : 8400032

    Jonesboro, Arkansas, 72401

  • Wee Care Pediatrics Site Number : 8400035

    Kaysville, Utah, 84037

  • Children's Research, LLC Site Number : 8400063

    Lake Mary, Florida, 32746

  • FMC SCIENCE Site Number : 8400053

    Lampasas, Texas, 76550

  • Tanner Clinic Site Number : 8400018

    Layton, Utah, 84041

  • Matrix Clinical Research Site Number : 8400095

    Los Angeles, California, 90057

  • Brownsboro Park Pediatrics Site Number : 8400010

    Louisville, Kentucky, 40207

  • All Children Pediatrics Site Number : 8400043

    Louisville, Kentucky, 40243

  • Axcess Medical Research Site Number : 8400068

    Loxahatchee Groves, Florida, 33470

  • Velocity Clinical Research Site Number : 8400025

    Metairie, Louisiana, 70006

  • Acevedo Clinical Research Associates Site Number : 8400001

    Miami, Florida, 33186

  • Tiga Pediatrics Site Number : 8400137

    New York, New York, 10467

  • Creighton University Site Number : 8400039

    Omaha, Nebraska, 68131

  • Florida Hospital Medical Group Pediatrics Site Number : 8400108

    Orlando, Florida, 32803

  • IMIC Inc Site Number : 8400022

    Palmetto Bay, Florida, 33157

  • Center for Clinical Trials, LLC Site Number : 8400030

    Paramount, California, 90723

  • MedPharmics, LLC - Phoenix Site Number : 8400083

    Phoenix, Arizona, 85015

  • Pediatric Care Site Number : 8400056

    Provo, Utah, 84064

  • Wee Care Pediatrics Roy Site Number : 8400029

    Roy, Utah, 84067

  • Tekton Research, Inc Site Number : 8400049

    San Antonio, Texas, 78229

  • Tekton Research Site Number : 8400128

    San Antonio, Texas, 78244

  • LSUHSC-Shreveport Site Number : 8400120

    Shreveport, Louisiana, 71103

  • Virgo-Carter Pediatrics Site Number : 8400041

    Silver Spring, Maryland, 20910

  • Parkside Pediatrics - Simpsonville Site Number : 8400113

    Simpsonville, South Carolina, 29681

  • Copperview Medical Center Site Number : 8400038

    South Jordan, Utah, 84095

  • Wee Care Pediatrics Syracuse Site Number : 8400024

    Syracuse, Utah, 84075-9143

  • Alliance for Multispecialty Research Syracuse Site Number : 8400036

    Syracuse, Utah, 84075-9645

  • Jedidiah Clinical Research Site Number : 8400132

    Tampa, Florida, 33617

  • Pediatric Clinical Trials Tullahoma Site Number : 8400033

    Tullahoma, Tennessee, 37388

  • Center for Clinical Trials of San Gabriel Site Number : 8400076

    West Covina, California, 91790

Other trials in United States

Puerto Rico5 sites

  • Investigational Site Number : 6300116

    Caguas, 00726

  • Investigational Site Number : 6300122

    Guayama, 000784

  • Investigational Site Number : 6300015

    San Juan, 00918

  • Investigational Site Number : 6300117

    San Juan, 00918

  • Investigational Site Number : 6300140

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States

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.

Read the detailed 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.

Being tested
MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine, Pneumococcal 13-valent conjugate vaccine, Pentavalent rotavirus vaccine
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

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

  • MenACYW-135 conjugate vaccineBiological

    Also called MENVEO®

    Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular

  • DTaP-IPV//Hib vaccineBiological

    Also called Pentacel®

    DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular

  • Pneumococcal 13-valent conjugate vaccineBiological

    Also called PREVNAR 13®

    Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular

  • Pentavalent rotavirus vaccineBiological

    Also called RotaTeq®

    Rotavirus vaccine at 2, 4, and 6 months of age, oral solution

  • Hepatitis B vaccineBiological

    Also called ENGERIX-B®

    Hepatitis B vaccine at 2 and 6 months of age, Intramuscular

  • Measles, mumps, rubella (MMR) vaccineBiological

    Also called M-M-R® II

    MMR vaccine at 12 months of age, Subcutaneous

  • Varicella vaccineBiological

    Also called VARIVAX®

    Varicella vaccine at 12 months of age

  • Hepatitis A vaccineBiological

    Also called HAVRIX®

    Hepatitis A vaccine at 15 to 18 months of age

Study groups in NCT03537508
Study groupRoleWhat they receive
Group 1aExperimentalMenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV//Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Varicella vaccine
Group 1bExperimentalMenACYW 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
Receives: Biological: MenACYW conjugate vaccine; Biological: DTaP-IPV//Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Varicella vaccine; Biological: Hepatitis A vaccine
Group 2aActive comparatorMENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Receives: Biological: MenACYW-135 conjugate vaccine; Biological: DTaP-IPV//Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Varicella vaccine
Group 2bActive comparatorMENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age
Receives: Biological: MenACYW-135 conjugate vaccine; Biological: DTaP-IPV//Hib vaccine; Biological: Pneumococcal 13-valent conjugate vaccine; Biological: Pentavalent rotavirus vaccine; Biological: Hepatitis B vaccine; Biological: Measles, mumps, rubella (MMR) vaccine; Biological: Varicella vaccine; Biological: Hepatitis A vaccine

What is being measured

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

  1. Groups 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination

    Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer >=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >=1:8. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 12-month vaccination (Month 13)

  2. Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titers >=1:8 by hSBA at Day 30 Post 6-Month Vaccination

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

    Measured: Day 30 post 6-month vaccination (Month 7)

Secondary outcomes (15)

  1. Groups 1 and 2: Percentage of Participants Who Achieved Anti-Hepatitis B Antibody Concentrations >=10 Milli-International Units Per Milliliter (mIU/mL) at Day 30 Post 6-Month Vaccination

    Anti-Hepatitis B surface antibodies (HBsAg) were measured by the commercially available VITROS ECi/ECiQ immunodiagnostic system using chemiluminescence detection technology. The percentage of participants with an anti-HBsAg antibody titer >=10 mIU/mL was assessed. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 6-month vaccination (Month 7)

  2. Groups 1 and 2: Percentage of Participants Who Achieved Anti-Polyribosyl-Ribitol (PRP) Antibody Concentrations >=0.15 and >=1.0 Microgram (mcg)/mL at Day 30 Post 6-Month Vaccination

    Anti-PRP concentrations were measured using a farr-type radioimmunoassay (RIA). The percentage of participants with an PRP antibody titer >=0.15 mcg/mL and >=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 6-month vaccination (Month 7)

  3. Groups 1 and 2: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 6-Month Vaccination

    Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers >=1:8 were assessed.

    Measured: Day 30 post 6-month vaccination (Month 7)

  4. Groups 1 and 2: Percentage of Participants Who Achieved Anti-Rotavirus Immunoglobulin A (IgA) Antibody Concentrations >=3-Fold Rise at Day 30 Post 6-Month Vaccination

    Anti-rotavirus IgA antibodies in human serum were measured by enzyme-linked immunosorbent assay (ELISA). The percentage of participants who achieved anti-rotavirus IgA Ab concentrations >=3-fold rise were assessed. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 6-month vaccination (Month 7)

  5. Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Anti-Rotavirus IgA Antibodies at Day 30 Post 6-Month Vaccination

    GMCs of anti-rotavirus serum IgA antibodies were assessed using ELISA.

    Measured: Day 30 post 6-month vaccination (Month 7)

  6. Groups 1 and 2: GMCs of Anti-Pertussis Antibodies at Day 30 Post 6-Month Vaccination

    GMCs of anti-pertussis antibodies (pertussis toxoid [PT], filamentous hemagglutinin adhesin [FHA], pertactin [PRN] and fimbriae types 2 and 3 [FIM]) were measured by electrochemiluminescent (ECL) assay.

    Measured: Day 30 post 6-month vaccination (Month 7)

  7. Groups 1 and 2: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 6-Month Vaccination

    GMCs of anti-pneumococcal antibodies was assessed by pneumococcal capsular polysaccharide (PnPS) IgG ECL assay which is 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: Day 30 post 6-month vaccination (Month 7)

  8. Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Measles, Mumps and Rubella (MMR) Antibodies at Day 30 Post 12-Month Vaccination

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

    Measured: Day 30 post 12-month vaccination (Month 13)

  9. Groups 1a and 2a: Percentage of Participants Who Achieved Vaccine Response for Varicella Antibodies at Day 30 Post 12-Month Vaccination

    Vaccine response against anti-varicella antibodies were measured by glycoprotein (gp) ELISA. Percentage of participants with anti-varicella antibody concentration >=5 antibody (Ab) gpELISA units/mL are reported. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 12-month vaccination (Month 13)

  10. Groups 1a and 2a: GMCs of Anti-Pneumococcal Antibodies at Day 30 Post 12-Month Vaccination

    GMCs of anti-pneumococcal antibodies was assessed by PnPS IgG ECL assay which is 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: Day 30 post 12-month vaccination (Month 13)

  11. Groups 1b and 2b: Percentage of Participants Who Achieved Anti-PRP Antibody Concentrations >=1.0 mcg/mL at Day 30 Post 15-Month Vaccination

    Anti-PRP concentrations were measured using a farr-type RIA. The percentage of participants with an PRP antibody titers >=1.0 mcg/mL were assessed. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 15-month vaccination (Month 16)

  12. Groups 1b and 2b: Percentage of Participants Who Achieved Anti-Poliovirus Antibody Titers >=1:8 at Day 30 Post 15-Month Vaccination

    Anti-poliovirus types 1, 2, and 3 were measured by neutralization assay. The percentage of participants with anti-polio antibody titers >=1:8 are assessed.

    Measured: Day 30 post 15-month vaccination (Month 16)

  13. Groups 1b and 2b: Percentage of Participants Who Achieved Vaccine Response for Anti-Pertussis Antibodies at Day 30 Post 15-Month Vaccination

    Vaccine response was defined as: if the pre-booster (4th) vaccination concentration was <lower limit of quantification (LLOQ), then the post-booster (4th) vaccination concentration should be >=4 times LLOQ. The LLOQ was equal to 2.00 EU/mL. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 15-month vaccination (Month 16)

  14. Groups 1a and 2a: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination

    GMTs of antibody against meningococcal serogroups A, C, Y, and W were measured by hSBA. PPAS2 included participants of FAS2 (subset of all randomized participants who received >=1 dose of the study vaccine in infancy [at Visit 1 to 3, < 12 months of age] and had a valid pre-vaccination serology result at Visit 5 before the 12-month vaccinations for Subgroups 1a and 2a or at Visit 6 before the 15-month vaccinations for Subgroups 1b and 2b) with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn.

    Measured: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)

  15. Groups 1a and 2a: Percentage of Participants Who Achieved Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W at Day 30 Post 6-Month Vaccination and Day 0 Before 12-Month Vaccination

    Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. PPAS2 included participants of FAS2 with no relevant protocol deviations during infancy and for whom a pre-dose serology sample at Visit 5 for Subgroups 1a and 2a before the 12-month vaccinations or Visit 6 for Subgroups 1b and 2b before the 15-month vaccinations was not withdrawn. Percentages are rounded off to the tenth decimal place.

    Measured: Day 30 post 6-month vaccination (Month 7) and Day 0 before 12-month vaccination (Month 12)

Timeline

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

  1. First posted25 May 2018
  2. Study start25 Apr 2018
  3. Primary completion22 Sep 2023
  4. Study completion22 Sep 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
2,627 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03537508
Sponsor's protocol ID
MET42
Other IDs
U1111-1183-6361, 2018-001473-24, 2018
Status last verified
Oct 2024
First submitted
15 May 2018
Last updated
15 Oct 2024
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

  • Campbell JD, Gupta S, Dhingra MS, Zambrano B, Gan L, B'Chir S, Chaix J, Syrkina O, Masson J, Liabis O, Rehm C. A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico. Hum Vaccin Immunother. 2025 Dec;21(1):2588874. doi: 10.1080/21645515.2025.2588874. Epub 2025 Dec 3.

    PubMed 41337697

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine and DTaP-IPV//Hib vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 70 sites in 2 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 25 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Puerto Rico. 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 15 Oct 2024). 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 1a and 2a: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at Day 30 Post 12-Month Vaccination (time frame: Day 30 post 12-month vaccination (Month 13)). The study lists 2 primary outcomes in all. 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 NCT03537508, 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 15 Oct 2024.

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