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

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ClinicalTrials.gov Identifier: NCT03537508
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE May 15, 2018
First Posted Date  ICMJE May 25, 2018
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE April 25, 2018
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • Level of antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Before and 30 days after the 12-month vaccination ]
  • Percentage of participants with ≥ 4-fold rise in antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: From pre-4th dose to post-4th dose ]
  • Level of antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after 6-month vaccination and before 12-month vaccination ]
  • Percentage of participants with antibody titers ≥1:4 and ≥ 1:8 against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after 6-month vaccination and before 12-month vaccination ]
  • Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after vaccination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2018)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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
  • 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 ]
  • 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 ]
  • 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 ]
  • Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after vaccination ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
Official Title  ICMJE Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
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.
  • To assess the antibody responses against meningococcal serogroups A, C, Y, and W after the administration of the 4th dose of MenACYW conjugate vaccine as compared with MENVEO® when both are given concomitantly with routine pediatric vaccines at 12 months of age.
  • To assess the persistence of bactericidal antibodies at 12 months of age (prior to the 4th dose) in participants who previously received 3 doses of MenACYW conjugate vaccine or MENVEO® in infancy concomitantly with routine pediatric vaccines at 2, 4, and 6 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

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Condition  ICMJE Meningococcal Infections
Intervention  ICMJE
  • Biological: MenACYW conjugate vaccine
    Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
  • 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
Study Arms  ICMJE
  • Experimental: Group 1a
    MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
  • 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
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2018)
2475
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Aged ≥ 42 to ≤ 89 days on the day of the first study visit.
  • Healthy infants as determined by medical history, physical examination, and judgment of the investigator
  • Informed consent form has been signed and dated by the parent(s) or guardian, and an independent witness, if required by local regulations
  • Participant and parent/guardian 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 (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, 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 participant 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 89 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Trial Transparency Toll free number for US & Canada - e-mail is recommended) 800-633-1610 ext 1 then # Contact-US@sanofi.com
Listed Location Countries  ICMJE Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03537508
Other Study ID Numbers  ICMJE MET42
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
PRS Account Sanofi
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP