ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03537508
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of this study is 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.

Primary objectives:

  • To demonstrate the non-inferiority of the immune response after a 4-dose series of MenACYW conjugate vaccine compared to a 4-dose series of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 weeks to 15 months of age.
  • To demonstrate the non-inferiority of the immune response after 3 doses of MenACYW conjugate vaccine compared to 3 doses of MENVEO when given concomitantly with routine pediatric vaccines to infants at 2, 4, and 6 months of age.

Secondary objective:

• To demonstrate the non-inferiority of the immune responses of the routine pediatric vaccines administered concomitantly with MenACYW conjugate vaccine as compared with MENVEO to infants and toddlers 6 weeks to 18 months of age.

Observational objective:

• To describe the safety profile of MenACYW conjugate vaccine and MENVEO when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.


Condition or disease Intervention/treatment Phase
Meningococcal Infections Biological: MenACYW conjugate vaccine 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 Phase 3

Detailed Description:

Healthy infants will be enrolled and randomized to receive either 4 doses of MenACYW conjugate vaccine or 4 doses of the licensed control vaccine, MENVEO®. All participants will receive routine vaccines as per the Advisory Committee on Immunization Practices (ACIP) recommendations.

All participants will be assessed for immunogenicity at baseline (pre-vaccination), and after completing the infant schedule and the second year of life vaccination schedule.

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 trial.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2475 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Modified double blind for the infant part of the study, with everyone involved in the study (participants/parents, investigators, safety outcome assessor, Sponsor) blinded to the meningococcal vaccine received, except the personnel administering the vaccine. During the toddler part of the study, individuals blinded during the infant part of the study might be potentially unblinded due to the different timing of and age of the participants at the vaccination visits and the number of vaccines received during these visits.
Primary Purpose: Prevention
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
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1a
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Biological: MenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

Biological: DTaP-IPV//Hib vaccine
DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age

Biological: Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age

Biological: Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age

Biological: Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age

Biological: Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age

Biological: Varicella vaccine
Varicella vaccine at 12 months of age

Experimental: Group 1b
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
Biological: MenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular

Biological: DTaP-IPV//Hib vaccine
DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age

Biological: Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age

Biological: Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age

Biological: Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age

Biological: Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age

Biological: Varicella vaccine
Varicella vaccine at 12 months of age

Biological: Hepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age

Active Comparator: Group 2a
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
Biological: MenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
Other Name: MENVEO®

Biological: DTaP-IPV//Hib vaccine
DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age

Biological: Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age

Biological: Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age

Biological: Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age

Biological: Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age

Biological: Varicella vaccine
Varicella vaccine at 12 months of age

Active Comparator: Group 2b
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
Biological: MenACYW-135 conjugate vaccine
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
Other Name: MENVEO®

Biological: DTaP-IPV//Hib vaccine
DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age

Biological: Pneumococcal 13-valent conjugate vaccine
Pneumococcal vaccine at 2, 4, 6, and 12 months of age

Biological: Pentavalent rotavirus vaccine
Rotavirus vaccine at 2, 4, and 6 months of age

Biological: Hepatitis B vaccine
Hepatitis B vaccine at 2 and 6 months of age

Biological: Measles, mumps, rubella (MMR) vaccine
MMR vaccine at 12 months of age

Biological: Varicella vaccine
Varicella vaccine at 12 months of age

Biological: Hepatitis A vaccine
Hepatitis A vaccine at 15 to 18 months of age




Primary Outcome Measures :
  1. Level of antibody titers against meningococcal serogroups A, C, Y, and W after 4 doses of meningococcal vaccine given concomitantly with routine vaccines [ Time Frame: 30 days after the fourth meningococcal vaccination ]
    Titers are measured by serum bactericidal assay using human complement (hSBA)

  2. Percentage of participants with antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W after 3 doses of meningococcal vaccine given concomitantly with routine vaccines [ Time Frame: 30 days after vaccination at 6 months of age ]
    Titers are measured by hSBA


Secondary Outcome Measures :
  1. IgG antibodies against hepatitis B surface antigen (anti-HB) at concentrations ≥ 10 milli-international units (mIU) / mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: 30 days after vaccination at 6 months of age ]
  2. Anti polyribosyl-ribitol phosphate (PRP) antibody concentrations ≥ 0.15 and ≥ 1.0 µg/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: 30 days after vaccination at 6 months of age ]
  3. Anti-poliovirus types 1, 2, and 3 antibody titers ≥ 1:8 after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: 30 days after vaccination at 6 months of age ]
  4. Anti-rotavirus serum IgA antibody concentrations with ≥ 3-fold rise over baseline after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: Day 0 (pre-vaccination) and 30 days after vaccination at 6 months of age ]
  5. Anti-rotavirus serum IgA antibody geometric mean concentrations (GMCs) after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: 30 days after vaccination at 6 months of age ]
  6. Anti-pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM]) antibody concentrations after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: Day 0 (pre-vaccination) and 30 days after vaccination at 6 months of age ]
  7. Anti-pneumococcal antibody concentrations after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after vaccination at 6 months of age) [ Time Frame: 30 days after vaccination at 6 months of age ]
    Anti-pneumococcal antibodies against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F will be measured

  8. Anti-measles antibody concentrations ≥ 255 mIU/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 12-month vaccination) [ Time Frame: 30 days after the 12-month vaccination ]
  9. Anti-mumps antibody concentrations ≥ 10 mumps antibody units/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 12-month vaccination) [ Time Frame: 30 days after the 12-month vaccination ]
  10. Anti-rubella antibody concentrations ≥ 10 IU/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 12-month vaccination) [ Time Frame: 30 days after the 12-month vaccination ]
  11. Anti-varicella antibody concentrations ≥ 5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 12-month vaccination) [ Time Frame: 30 days after the 12-month vaccination ]
  12. Anti-pneumococcal antibody concentrations after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 12-month vaccination) [ Time Frame: 30 days after the 12-month vaccination ]
    Anti-pneumococcal antibody concentrations against serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F will be measured

  13. Anti-PRP antibody concentrations ≥ 1.0 µg/mL after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 15-month vaccination) [ Time Frame: 30 days after the 15-month vaccination ]
  14. Anti-poliovirus types 1, 2, and 3 antibody titers ≥ 1:8 after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 15-month vaccination) [ Time Frame: 30 days after the 15-month vaccinations ]
  15. Anti-pertussis antibody concentrations (PT, FHA, PRN, and FIM) (seroresponse) after concomitant vaccination with MenACYW conjugate vaccine or MENVEO® (after the 15-month vaccination) [ Time Frame: 30 days after the 15-month vaccination ]
  16. Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   42 Days to 89 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations
  • Subject and parent/guardian are 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 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., 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 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°C [≥ 100.4°F]). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
  • Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537508


Contacts
Contact: Trial Transparency Toll free number for US & Canada - e-mail is recommended) 800-633-1610 ext 1 then # RegistryContactUs@sanofipasteur.com

  Hide Study Locations
Locations
United States, Alabama
Sanofi Pasteur Investigational Site 840-0026 Recruiting
Birmingham, Alabama, United States, 35205
Sanofi Pasteur Investigational Site840-0003 Recruiting
Dothan, Alabama, United States, 36305
United States, Arizona
Sanofi Pasteur Investigational Site 840-0083 Recruiting
Phoenix, Arizona, United States, 85015
Sanofi Pasteur Investigational Site 840-0006 Recruiting
Tucson, Arizona, United States, 85741
United States, Arkansas
Sanofi Pasteur Investigational Site 840-0011 Recruiting
Fayetteville, Arkansas, United States, 72703
Sanofi Pasteur Investigational Site 840-0032 Recruiting
Jonesboro, Arkansas, United States, 72401
United States, California
Sanofi Pasteur Investigational Site 840-0031 Recruiting
Anaheim, California, United States, 92804
Sanofi Pasteur Investigational Site 840-0042 Recruiting
Anaheim, California, United States, 92805
Sanofi Pasteur Investigational Site 840-0007 Recruiting
Downey, California, United States, 90241
Sanofi Pasteur Investigational Site 840-0061 Recruiting
Fresno, California, United States, 93720
Sanofi Pasteur Investigational Site 840-0019 Recruiting
Long Beach, California, United States, 90806
Sanofi Pasteur Investigational Site 840-0054 Recruiting
Montclair, California, United States, 91763
Sanofi Pasteur Investigational Site 840-0030 Recruiting
Paramount, California, United States, 90723
Sanofi Pasteur Investigational Site 840-0076 Recruiting
West Covina, California, United States, 91790
United States, Florida
Sanofi Pasteur Investigational Site 840-0077 Recruiting
DeLand, Florida, United States, 32720
Sanofi Pasteur Investigational Site 840-0012 Recruiting
Doral, Florida, United States, 33166
Sanofi Pasteur Investigational Site 840-0057 Recruiting
Hialeah, Florida, United States, 33013
Sanofi Pasteur Investigational Site 840-0014 Recruiting
Homestead, Florida, United States, 33030
Sanofi Pasteur Investigational Site 840-0040 Recruiting
Homestead, Florida, United States, 33030
Sanofi Pasteur Investigational Site 840-0063 Recruiting
Lake Mary, Florida, United States, 32746
Sanofi Pasteur Investigational Site 840-0068 Recruiting
Loxahatchee Groves, Florida, United States, 33470
Sanofi Pasteur Investigational Site 840-0001 Recruiting
Miami, Florida, United States, 33142
Sanofi Pasteur Investigational Site 840-0022 Recruiting
Palmetto Bay, Florida, United States, 33157
Sanofi Pasteur Investigational Site 840-0064 Recruiting
Spring Hill, Florida, United States, 34609
United States, Georgia
Sanofi Pasteur Investigational Site 840-0008 Recruiting
Atlanta, Georgia, United States, 30338
United States, Idaho
Sanofi Pasteur Investigational Site 840-0073 Recruiting
Idaho Falls, Idaho, United States, 83404
United States, Kentucky
Sanofi Pasteur Investigational Site 840-0010 Recruiting
Louisville, Kentucky, United States, 40207
Sanofi Pasteur Investigational Site 840-0043 Recruiting
Louisville, Kentucky, United States, 40243
United States, Louisiana
Sanofi Pasteur Investigational Site 840-0023 Recruiting
Haughton, Louisiana, United States, 71037
Sanofi Pasteur Investigational Site 840-0025 Recruiting
Metairie, Louisiana, United States, 70006
United States, Maryland
Sanofi Pasteur Investigational Site 840-0004 Recruiting
Frederick, Maryland, United States, 21702
Sanofi Pasteur Investigational Site 840-0041 Recruiting
Silver Spring, Maryland, United States, 20910
United States, Missouri
Sanofi Pasteur Investigational Site 840-0037 Recruiting
Bridgeton, Missouri, United States, 63044
United States, Nebraska
Sanofi Pasteur Investigational Site 840-0039 Recruiting
Omaha, Nebraska, United States, 68131
United States, New York
Sanofi Pasteur Investigational Site 840-0045 Recruiting
East Syracuse, New York, United States, 13057
United States, North Carolina
Sanofi Pasteur Investigational Site 840-0027 Recruiting
Cornelius, North Carolina, United States, 28031
United States, Ohio
Sanofi Pasteur Investigational Site 840-0051 Recruiting
Cincinnati, Ohio, United States, 45206
Sanofi Pasteur Investigational Site 840-0084 Recruiting
Dayton, Ohio, United States, 45414
Sanofi Pasteur Investigational Site 840-0002 Recruiting
Dayton, Ohio, United States, 45419
United States, Oregon
Sanofi Pasteur Investigational Site 840-0085 Recruiting
Gresham, Oregon, United States, 97030
United States, Pennsylvania
Sanofi Pasteur Investigational Site 840-0047 Recruiting
Erie, Pennsylvania, United States, 16506
United States, South Carolina
Sanofi Pasteur Investigational Site 840-0005 Recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
Sanofi Pasteur Investigational Site 840-0033 Recruiting
Tullahoma, Tennessee, United States, 37388
United States, Texas
Sanofi Pasteur Investigational Site 840-0059 Recruiting
Austin, Texas, United States, 78726
Sanofi Pasteur Investigational Site 840-0065 Recruiting
Dallas, Texas, United States, 75231
Sanofi Pasteur Investigational Site 840-0075 Recruiting
Fort Worth, Texas, United States, 76104
Sanofi Pasteur Investigational Site 840-0079 Recruiting
Fort Worth, Texas, United States, 76107
Sanofi Pasteur Investigational Site 840-0067 Recruiting
Galveston, Texas, United States, 77555
Sanofi Pasteur Investigational Site 840-0013 Recruiting
Houston, Texas, United States, 77055
Sanofi Pasteur Investigational Site 840-0053 Recruiting
Lampasas, Texas, United States, 76550
Sanofi Pasteur Investigational Site 840-0049 Recruiting
San Antonio, Texas, United States, 78240
Sanofi Pasteur Investigational Site 840-0078 Recruiting
Spring, Texas, United States, 77389
United States, Utah
Sanofi Pasteur Investigational Site 840-0016 Recruiting
Clinton, Utah, United States, 84015
Sanofi Pasteur Investigational Site 840-0035 Recruiting
Kaysville, Utah, United States, 84307
Sanofi Pasteur Investigational Site 840-0018 Recruiting
Layton, Utah, United States, 84041
Sanofi Pasteur Investigational Site 840-0024 Recruiting
Layton, Utah, United States, 84041
Sanofi Pasteur Investigational Site 840-0036 Recruiting
Layton, Utah, United States, 84041
Sanofi Pasteur Investigational Site 840-0056 Recruiting
Provo, Utah, United States, 84064
Sanofi Pasteur Investigational Site 840-0029 Recruiting
Roy, Utah, United States, 84067
Sanofi Pasteur Investigational Site 840-0038 Recruiting
South Jordan, Utah, United States, 84095
United States, West Virginia
Sanofi Pasteur Investigational Site 840-0062 Recruiting
Huntington, West Virginia, United States, 25701
Puerto Rico
Sanofi Pasteur Investigational Site 630-0015 Recruiting
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03537508     History of Changes
Other Study ID Numbers: MET42
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningococcal meningitis
MenACYW conjugate vaccine
Quadrivalent meningococcal vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs