Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Sponsor:
Sanofi Pasteur, a Sanofi Company
Collaborators:
Information provided by (Responsible Party):
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| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | September 28, 2018 | ||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | 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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| Official Title ICMJE | Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers |
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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 objective is to demonstrate the non-inferiority of the percentage of subjects 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. The study also includes as an 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. |
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| Detailed Description | Study duration per participant is approximately 1 year in Group 1 and Group 2, and 10 months in Group 3 and Group 4. This duration includes a safety follow-up contact at 6 months after the last vaccination. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 3 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional 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 |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
940 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | June 2020 | ||
| Estimated Primary Completion Date | June 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion criteria : - Aged 6 to 7 months (164 to 224 days) or 17 to 19 months on the day of the first 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 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 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) or rotavirus vaccine - For subjects to be enrolled at 6 to 7 months of age (Group 1 and Group 2), receipt of the 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. | ||
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| Ages | 6 Months and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Administrative Information | 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 |
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| IPD Sharing Statement |
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| Responsible Party | ， | ||
| Study Sponsor ICMJE | Sanofi Pasteur, a Sanofi Company | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | |||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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