Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
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| ClinicalTrials.gov Identifier: NCT03691610 |
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Recruitment Status :
Recruiting
First Posted : October 2, 2018
Last Update Posted : February 18, 2022
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Brief Summary:
The primary objective of this study is to demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with routine pediatric vaccines to infants and toddlers 6 to 7 months of age and 12 to 13 months of age.
The secondary objectives of the study are:
- To demonstrate the non-inferiority of the percentage of participants with antibody titers to meningococcal serogroups A, C, Y, and W ≥ 1:8 following administration of 2 doses of MenACYW conjugate vaccine compared to 2 doses of MENVEO® when given concomitantly with pediatric routine vaccines to infants and toddlers at 6 to 7 months of age and 12 to 13 months of age.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 12 to 13 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days and 6 months after the first vaccination at 6 to 7 months of age with MenACYW conjugate vaccine or MENVEO®.
- To describe the antibody response against meningococcal serogroups A, C, Y, and W 30 days after the second vaccination at 20 to 23 months of age with MenACYW conjugate vaccine or Menactra®.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Healthy Volunteers (Meningococcal Infection) | Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Biological: Haemophilus b Conjugate Vaccine Biological: Pneumococcal 13-valent Conjugate Vaccine Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Hepatitis B Vaccine Biological: Measles, Mumps, and Rubella Virus Vaccine Live Biological: Varicella Virus Vaccine Live | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1070 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The study has a modified double blind design for each group at enrollment, and thus, with the exception of the personnel administering the vaccine, everyone involved in study is blinded to avoid any bias. |
| Primary Purpose: | Prevention |
| Official Title: | Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers |
| Actual Study Start Date : | October 4, 2018 |
| Estimated Primary Completion Date : | May 2023 |
| Estimated Study Completion Date : | May 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
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Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Haemophilus b Conjugate Vaccine Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL Biological: Pneumococcal 13-valent Conjugate Vaccine Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL Biological: Hepatitis B Vaccine Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Measles, Mumps, and Rubella Virus Vaccine Live Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL Biological: Varicella Virus Vaccine Live Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL |
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Active Comparator: Group 2
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
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Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Haemophilus b Conjugate Vaccine Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL Biological: Pneumococcal 13-valent Conjugate Vaccine Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL Biological: Hepatitis B Vaccine Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL Biological: Measles, Mumps, and Rubella Virus Vaccine Live Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL Biological: Varicella Virus Vaccine Live Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL |
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Experimental: Group 3
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
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Biological: Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL |
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Active Comparator: Group 4
Menactra® at 17 to 19 months of age and 20 to 23 months of age
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Biological: Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL |
Primary Outcome Measures :
- Antibody titers against meningococcal serogroups A, C, Y, and W [ Time Frame: 30 days after the second dose of meningococcal vaccine ]Antibody titers are measured by serum bactericidal assay using human complement (hSBA)
Secondary Outcome Measures :
- Antibody titers ≥ 1:8 against meningococcal serogroups A, C,Y, and W 30 days after the second dose of meningococcal vaccine [ Time Frame: 30 days after the second dose of meningococcal vaccine ]Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8
- Percentage of subjects with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the second of dose of meningococcal vaccine [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
- Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the first dose of meningococcal vaccine [ Time Frame: 30 days after the first dose of meningococcal vaccine ]
- Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the first dose of meningococcal vaccine [ Time Frame: 30 days after the first dose of meningococcal vaccine ]
- Percentage of participants with hSBA vaccine seroresponse 30 days after the first dose of meningococcal vaccine [ Time Frame: 30 days after the first dose of meningococcal vaccine ]The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8
- Antibody titers against meningococcal serogroups A, C, Y, and W 6 months after the first dose of meningococcal vaccine [ Time Frame: 6 months after the first dose of meningococcal vaccine ]
- Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 6 months after the first dose of meningococcal vaccine [ Time Frame: 6 months after the first dose of meningococcal vaccine ]
- Percentage of participants with hSBA vaccine seroresponse 6 months after the first dose of meningococcal vaccine [ Time Frame: 6 months after the first dose of meningococcal vaccine ]The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8
- Antibody titers against meningococcal serogroups A, C, Y, and W 30 days after the second dose of meningococcal vaccine [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
- Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 30 days after the second dose of meningococcal vaccine [ Time Frame: 30 days after the second dose of meningococcal vaccine ]
- Percentage of participants with hSBA vaccine seroresponse 30 days after the second dose of meningococcal vaccine [ Time Frame: 30 days after the second 30 days after the second dose of meningococcal vaccine ]The hSBA vaccine seroresponse for serogroups A, C, Y, and W is defined as post-vaccination hSBA titers >=1:16 for participants with pre-vaccination titers <1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers >=1:8
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| Ages Eligible for Study: | 6 Months to 19 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria :
- Aged 6 to 7 months (168 to 224 days) or 17 to 19 months on the day of the first visit
- Informed consent form has been signed and dated by the parent(s) or other guardian and by 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
- For subjects 6 to 7 months of age at enrollment (Group 1 and Group 2), documented history of having received 2 doses of diphtheria, tetanus and acellular pertussis (DTaP), Haemophilus influenza type B (Hib), inactivated poliovirus (IPV), pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of 3 doses of hepatitis B), and rotavirus vaccines
- For subjects to be enrolled at 17 to 19 months of age (Group 3 and Group 4), documented history of having received all routine pediatric vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) up to the age of enrollment
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 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, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), prior receipt of more than 2 doses of rotavirus vaccine (Rotateq), DTaP, Hib, IPV, pneumococcal, hepatitis B (for children who received hepatitis B at 2 and 4 months of age, prior receipt of more than 3 doses of hepatitis B vaccine)
- For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 2 doses of rotavirus vaccine at 2 and 4 months of age
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) within the past 3 months
- 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 Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine
- 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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): NCT03691610
Contacts
| Contact: Trial Transparency email recommended (Toll free number for US & Canada) | 800-633-1610 ext 1 then # | Contact-US@sanofi.com |
Locations
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Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company |
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT03691610 |
| Other Study ID Numbers: |
MET61 U1111-1205-2836 ( Other Identifier: UTN ) |
| First Posted: | October 2, 2018 Key Record Dates |
| Last Update Posted: | February 18, 2022 |
| Last Verified: | February 17, 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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://www.clinicalstudydatarequest.com/ |
| 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.: | No |
Additional relevant MeSH terms:
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Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Vaccines Immunoglobulins Immunologic Factors Physiological Effects of Drugs |