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

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ClinicalTrials.gov Identifier: NCT03547271
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The primary objective of the study is to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old.

The secondary objectives are:

  • To demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old.
  • To describe the antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered in a 3-dose series concomitantly with the routine pediatric vaccines.
  • To describe the antibody responses against the antigens of the routine pediatric vaccines administered in a 3-dose series concomitantly with MenACYW conjugate vaccine or a licensed meningococcal vaccine.
  • To describe the safety profile of MenACYW conjugate vaccine and a licensed meningococcal vaccine.

Condition or disease Intervention/treatment Phase
Meningococcal Infections Biological: MenACYW conjugate vaccine Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine Biological: DTaP-IPV-HB-Hib vaccine Biological: Pneumococcal vaccine (13-valent) Biological: Pneumococcal vaccine (10-valent) Biological: MMR vaccine Phase 3

Detailed Description:

Healthy infants and toddlers will receive MenACYW conjugate vaccine or a licensed meningococcal vaccine, and routine pediatric vaccines.

All participants will be assessed for immunogenicity before and after vaccination.

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 study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Modified double blind for Groups 1 and 2 and open label for Groups 3 and 4 for meningococcal vaccines. Open-label for all concomitant routine vaccines.

Modified double-blind: the participants parent / legally acceptable representative, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccines but will not be involved in safety data collection.

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 in Europe
Actual Study Start Date : December 14, 2018
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
MenACYW conjugate vaccine, 3 doses, co-administered with routine vaccines (10-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and measles, mumps, and rubella [MMR] vaccine) at 2, 4 and 12 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-HB-Hib vaccine
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

Biological: Pneumococcal vaccine (10-valent)
Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)

Biological: MMR vaccine
Measles, mumps, and rubella vaccine

Active Comparator: Group 2
Licensed meningococcal vaccine (Nimenrix®), 3 doses, co-administered with routine vaccines (10-valent pneumococcal vaccine, DTaP-IPV- HB-Hib vaccine, and MMR vaccine) at 2, 4 and 12 to 18 months of age
Biological: Meningococcal group A, C, W-135, and Y conjugate vaccine
Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, intramuscular
Other Name: Nimenrix®

Biological: DTaP-IPV-HB-Hib vaccine
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

Biological: Pneumococcal vaccine (10-valent)
Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed)

Biological: MMR vaccine
Measles, mumps, and rubella vaccine

Experimental: Group 3
MenACYW conjugate vaccine, 3 doses, co-administered with routine vaccines (13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and MMR vaccine) at 2, 4 and 12 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-HB-Hib vaccine
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

Biological: Pneumococcal vaccine (13-valent)
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Biological: MMR vaccine
Measles, mumps, and rubella vaccine

Experimental: Group 4
MenACYW conjugate vaccine, 4 doses, co-administered with routine vaccines (13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine, and MMR vaccine) at 2, 4, and 12 to 18 months of age and administered alone at 6 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-HB-Hib vaccine
Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine

Biological: Pneumococcal vaccine (13-valent)
Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)

Biological: MMR vaccine
Measles, mumps, and rubella vaccine




Primary Outcome Measures :
  1. Antibody titers against meningococcal serogroups A, C, Y, and W (Groups 1 and 2) [ Time Frame: 30 days after dose 3 ]
    Antibody titers will be measured by the serum bactericidal assay using human complement (hSBA) and expressed as geometric mean titers (GMTs)


Secondary Outcome Measures :
  1. Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (Groups 1 and 2) [ Time Frame: 30 days after dose 2 ]
    Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8, measured by hSBA

  2. Antibody titers above pre-defined thresholds for meningococcal serogroups A, C, Y, and W (Group 3) [ Time Frame: Day 0, 30 days after dose 2, 1 day before dose 3 and 30 days after dose 3 ]
    Percentage of participants achieving antibody titers ≥ predefined thresholds, measured by hSBA

  3. Antibody titers against meningococcal serogroups A, C, Y, and W (Group 3) [ Time Frame: Day 0, 30 days after dose 2, 1 day before dose 3 and 30 days after dose 3 ]
    Antibody titers will be measured by hSBA and expressed as GMTs

  4. Antibody concentrations against pre-defined thresholds for antigens of DTaP-IPV-HB-Hib vaccine (Groups 1, 2, and 3) [ Time Frame: Day 0, 30 days after dose 2 and 30 days after dose 3 ]
    Percentage of participants with antibody concentrations ≥ established seroprotection cut-off levels for diphtheria, tetanus, polio, hepatitis B and Hib, and seroresponse rate for anti-pertussis antibodies

  5. Antibody concentrations/titers against antigens of DTaP-IPV- HB-Hib vaccine (Groups 1, 2, and 3) [ Time Frame: Day 0, 30 days after dose 2 and 30 days after dose 3 ]
    Antibody concentrations/titers will be measured by standard assays for the antigens contained in the vaccine

  6. Antibody concentrations above pre-defined thresholds for antigens of 10-valent pneumococcal vaccine (Groups 1 and 2) [ Time Frame: 30 days after dose 2 and 30 days after dose 3 ]
    Percentage of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine

  7. Antibody concentrations against antigens of 10-valent pneumococcal vaccine (Groups 1 and 2) [ Time Frame: 30 days after dose 2 and 30 days after dose 3 ]
    Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine

  8. Antibody concentrations above pre-defined thresholds for antigens of 13-valent pneumococcal vaccine (Group 3) [ Time Frame: 30 days after dose 2 and 30 days after dose 3 ]
    Percentage of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine

  9. Antibody concentrations against antigens of 13-valent pneumococcal vaccine (Group 3) [ Time Frame: 30 days after dose 2 and 30 days after dose 3 ]
    Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine

  10. Antibody concentrations above pre-defined thresholds for antigens of MMR vaccine (Groups 1, 2, and 3) [ Time Frame: 30 days after dose 3 ]
    Percentage of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in MMR vaccine

  11. Antibody concentrations against antigens of MMR vaccine (Groups 1, 2, and 3) [ Time Frame: 30 days after dose 3 ]
    Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine

  12. Solicited injection site reactions and systemic reactions [ Time Frame: Within 7 days after any injection ]
    Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability



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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 other legally acceptable representative (and by an independent witness if required by local regulations)
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
  • Covered by health insurance according to local regulations

Exclusion Criteria:

  • Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. This exclusion criterion does not apply to subjects in Finland or Sweden who plan to receive the licensed rotavirus vaccine during study vaccination visits.
  • Receipt or planned to receipt during the study period vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella. Previous vaccination against hepatitis B when administered to risk groups, as per local recommendation.
  • 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, unless 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 Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease
  • At high risk for meningococcal infection during the study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
  • Individuals with underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus [HIV] infection)
  • History of any neurologic disorders, including seizures and progressive neurologic disorders
  • History of Guillain-Barré syndrome
  • Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin
  • 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
  • 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 study conduct or completion
  • Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
  • Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
  • Infants born preterm (by less than 37 weeks of gestation) requiring specific immunization schedule for routine childhood vaccines and/or specific care at the time of vaccination, as per national recommendations

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): NCT03547271


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext option 6 Contact-US@sanofi.com

Locations
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi Pasteur, a Sanofi Company
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03547271    
Other Study ID Numbers: MET58
U1111-1183-6653 ( Other Identifier: WHO )
2017-004731-36 ( EudraCT Number )
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
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
Product Manufactured in and Exported from the U.S.: Yes
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
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs