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Trial record 1 of 1 for:    03537508
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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 : December 4, 2019
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.
  • 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


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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2475 participants
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
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 : December 2022
Estimated Study Completion Date : December 2022

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. Level of antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: Before and 30 days after the 12-month vaccination ]
  17. 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 ]
  18. 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 ]
  19. 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 ]
  20. 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.


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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.
  • 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

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

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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur, a Sanofi Company

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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: December 4, 2019
Last Verified: December 2019
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

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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:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs