Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Primary Purpose
Healthy Volunteers (Meningococcal Infection)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Haemophilus b Conjugate Vaccine
Pneumococcal 13-valent Conjugate Vaccine
Rotavirus Vaccine, Live, Oral, Pentavalent
Hepatitis B Vaccine
Measles, Mumps, and Rubella Virus Vaccine Live
Varicella Virus Vaccine Live
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Volunteers (Meningococcal Infection)
Eligibility 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.
Sites / Locations
- Alabama Clinical Therapeutics-Site Number:8400036Recruiting
- Southeastern Pediatric Associates-Site Number:8400009
- MedPharmics, LLC - Phoenix-Site Number:8400013Recruiting
- Emmaus Research Center, Inc-Site Number:8400019Recruiting
- Coast Clinical Trials, LLC-Site Number:8400073Recruiting
- Matrix Clinical Research-Site Number:8400082Recruiting
- Madera Family Med Group-Site Number:8400065Recruiting
- Next Phase Research Alliance-Site Number:8400044Recruiting
- PAS Research-Site Number:8400101Recruiting
- Axcess Medical Research-Site Number:8400021Recruiting
- Crystal Biomedical Research-Site Number:8400034Recruiting
- Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400046Recruiting
- Biomedical Research LLC-Site Number:8400041Recruiting
- PAS Research, LLC-Site Number:8400059Recruiting
- Invesclinic.US.LLC-Site Number:8400061Recruiting
- Omega Pediatrics-Site Number:8400093Recruiting
- Snake River Research, PLLC-Site Number:8400058Recruiting
- Eagle Clinical Research-Site Number:8400094Recruiting
- Brownsboro Park Pediatrics-Site Number:8400039Recruiting
- All Children Pediatrics-Site Number:8400024
- Meridian Clinical Research, LLC-Site Number:8400035Recruiting
- MedPharmics-Site Number:8400016
- Willis-Knighton Physician Network-Site Number:8400075Recruiting
- Victory Clinical Research-Site Number:8400026Recruiting
- Pediatric Associates of Fall River-Site Number:8400112Recruiting
- Craig Spiegel, MD-Site Number:8400023Recruiting
- Meridian Clinical Research-Site Number:8400097Recruiting
- Midwest Childrens Health Research Institute-Site Number:8400111Recruiting
- Midwest Childrens Health Research Institute-Site Number:8400117Recruiting
- MedPharmics Inc-Site Number:8400006
- Advantage Clinical Trials-Site Number:8400069Recruiting
- Wilmington Health-Site Number:8400054Recruiting
- Ohio Pediatric Research-Site Number:8400022Recruiting
- PriMed Clinical Research-Site Number:8400008Recruiting
- Oklahoma State University - Center for Health Sciences-Site Number:8400110Recruiting
- Cyn3rgy Research-Site Number:8400010
- Allegheny Health and Wellness Pavilion-Site Number:8400025Recruiting
- Kid's Way Pediatrics-Site Number:8400015Recruiting
- Coastal Pediatric Research Charleston-Site Number:8400002
- Coastal Pediatric Research Charleston-Site Number:8400011Recruiting
- Tribe Clinical Research-Site Number:8400118Recruiting
- Pediatric Clinical Trials Tullahoma-Site Number:8400106Recruiting
- ARC Clinical Research at Wilson Parke-Site Number:8400029Recruiting
- Tekton Research-Site Number:8400047Recruiting
- Mercury Clinical Research, Inc.-Site Number:8400088Recruiting
- Clinical Trial Network-Site Number:8400037Recruiting
- Dr Ruben Aleman & Associates-Site Number:8400062Recruiting
- Rio Grade Valley Clinical Research Institute-Site Number:8400084Recruiting
- Tekton Research, Inc.-Site Number:8400040Recruiting
- Investigational Site Number :6300102Recruiting
- Investigational Site Number :6300014Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Menactra® at 17 to 19 months of age and 20 to 23 months of age
Outcomes
Primary Outcome Measures
Antibody titers against meningococcal serogroups A, C, Y, and W
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
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
Antibody titers against meningococcal serogroups A, C, Y, and W 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
Percentage of participants with hSBA vaccine seroresponse 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
Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 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
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
Percentage of participants with titer ≥ 4-fold rise from pre-vaccination to post-vaccination 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
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
Full Information
NCT ID
NCT03691610
First Posted
September 28, 2018
Last Updated
August 11, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT03691610
Brief Title
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Official Title
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Study Type
Interventional
2. Study Status
Record Verification Date
August 11, 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
October 28, 2024 (Anticipated)
Study Completion Date
October 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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®.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Meningococcal Infection)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
1070 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
MenACYW conjugate vaccine + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
MENVEO® + routine pediatric vaccines at 6 to 7 months of age and 12 to 13 months of age
Arm Title
Group 3
Arm Type
Experimental
Arm Description
MenACYW conjugate vaccine at 17 to 19 months of age and 20 to 23 months of age
Arm Title
Group 4
Arm Type
Active Comparator
Arm Description
Menactra® at 17 to 19 months of age and 20 to 23 months of age
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide (Serogroups A,C,Y and W) Tetanus Toxoid Conjugate vaccine MenACYW conjugate vaccine
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Meningococcal Polysaccharide (serogroups A,C,Y and W-135) Diphtheria Toxoid Conjugate Vaccine
Intervention Description
Pharmaceutical form: Solution for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis, inactivated Poliovirus and Haemophilus b Conjugate Vaccine
Intervention Description
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Diphtheria and Tetanus Toxoids and Acellular Pertussis, Hepatitis B and Inactivated Poliovirus Vaccine
Intervention Description
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Haemophilus b Conjugate Vaccine
Intervention Description
Pharmaceutical form:Solution for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 13-valent Conjugate Vaccine
Intervention Description
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Rotavirus Vaccine, Live, Oral, Pentavalent
Intervention Description
Pharmaceutical form:Oral solution Route of administration: Oral, 2 mL
Intervention Type
Biological
Intervention Name(s)
Hepatitis B Vaccine
Intervention Description
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Measles, Mumps, and Rubella Virus Vaccine Live
Intervention Description
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous, 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Varicella Virus Vaccine Live
Intervention Description
Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous, 0.5 mL
Primary Outcome Measure Information:
Title
Antibody titers against meningococcal serogroups A, C, Y, and W
Description
Antibody titers are measured by serum bactericidal assay using human complement (hSBA)
Time Frame
30 days after the second dose of meningococcal vaccine
Secondary Outcome Measure Information:
Title
Antibody titers ≥ 1:8 against meningococcal serogroups A, C,Y, and W 30 days after the second dose of meningococcal vaccine
Description
Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8
Time Frame
30 days after the second dose of meningococcal vaccine
Title
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
Title
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
Title
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
Title
Percentage of participants with hSBA vaccine seroresponse 30 days after the first dose of meningococcal vaccine
Description
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
Time Frame
30 days after the first dose of meningococcal vaccine
Title
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
Title
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
Title
Percentage of participants with hSBA vaccine seroresponse 6 months after the first dose of meningococcal vaccine
Description
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
Time Frame
6 months after the first dose of meningococcal vaccine
Title
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
Title
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
Title
Percentage of participants with hSBA vaccine seroresponse 30 days after the second dose of meningococcal vaccine
Description
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
Time Frame
30 days after the second 30 days after the second dose of meningococcal vaccine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
19 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
1 then #
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Clinical Therapeutics-Site Number:8400036
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Pediatric Associates-Site Number:8400009
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Completed
Facility Name
MedPharmics, LLC - Phoenix-Site Number:8400013
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Individual Site Status
Recruiting
Facility Name
Emmaus Research Center, Inc-Site Number:8400019
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Individual Site Status
Recruiting
Facility Name
Coast Clinical Trials, LLC-Site Number:8400073
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Individual Site Status
Recruiting
Facility Name
Matrix Clinical Research-Site Number:8400082
City
Gardena
State/Province
California
ZIP/Postal Code
90247
Country
United States
Individual Site Status
Recruiting
Facility Name
Madera Family Med Group-Site Number:8400065
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Individual Site Status
Recruiting
Facility Name
Next Phase Research Alliance-Site Number:8400044
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Individual Site Status
Recruiting
Facility Name
PAS Research-Site Number:8400101
City
Land O' Lakes
State/Province
Florida
ZIP/Postal Code
34639
Country
United States
Individual Site Status
Recruiting
Facility Name
Axcess Medical Research-Site Number:8400021
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Crystal Biomedical Research-Site Number:8400034
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400046
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
Biomedical Research LLC-Site Number:8400041
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Name
PAS Research, LLC-Site Number:8400059
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Invesclinic.US.LLC-Site Number:8400061
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33415
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Pediatrics-Site Number:8400093
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Name
Snake River Research, PLLC-Site Number:8400058
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Individual Site Status
Recruiting
Facility Name
Eagle Clinical Research-Site Number:8400094
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60621
Country
United States
Individual Site Status
Recruiting
Facility Name
Brownsboro Park Pediatrics-Site Number:8400039
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
All Children Pediatrics-Site Number:8400024
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40243
Country
United States
Individual Site Status
Completed
Facility Name
Meridian Clinical Research, LLC-Site Number:8400035
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Individual Site Status
Recruiting
Facility Name
MedPharmics-Site Number:8400016
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Willis-Knighton Physician Network-Site Number:8400075
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Individual Site Status
Recruiting
Facility Name
Victory Clinical Research-Site Number:8400026
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Associates of Fall River-Site Number:8400112
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Individual Site Status
Recruiting
Facility Name
Craig Spiegel, MD-Site Number:8400023
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research-Site Number:8400097
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Childrens Health Research Institute-Site Number:8400111
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Childrens Health Research Institute-Site Number:8400117
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Individual Site Status
Recruiting
Facility Name
MedPharmics Inc-Site Number:8400006
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Advantage Clinical Trials-Site Number:8400069
City
New York
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Name
Wilmington Health-Site Number:8400054
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio Pediatric Research-Site Number:8400022
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Name
PriMed Clinical Research-Site Number:8400008
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Individual Site Status
Recruiting
Facility Name
Oklahoma State University - Center for Health Sciences-Site Number:8400110
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74127
Country
United States
Individual Site Status
Recruiting
Facility Name
Cyn3rgy Research-Site Number:8400010
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Allegheny Health and Wellness Pavilion-Site Number:8400025
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Individual Site Status
Recruiting
Facility Name
Kid's Way Pediatrics-Site Number:8400015
City
Hermitage
State/Province
Pennsylvania
ZIP/Postal Code
16148
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research Charleston-Site Number:8400002
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Coastal Pediatric Research Charleston-Site Number:8400011
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research-Site Number:8400118
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Clinical Trials Tullahoma-Site Number:8400106
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Recruiting
Facility Name
ARC Clinical Research at Wilson Parke-Site Number:8400029
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research-Site Number:8400047
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77706
Country
United States
Individual Site Status
Recruiting
Facility Name
Mercury Clinical Research, Inc.-Site Number:8400088
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trial Network-Site Number:8400037
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr Ruben Aleman & Associates-Site Number:8400062
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Individual Site Status
Recruiting
Facility Name
Rio Grade Valley Clinical Research Institute-Site Number:8400084
City
Pharr
State/Province
Texas
ZIP/Postal Code
78577
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research, Inc.-Site Number:8400040
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6300102
City
Guayama
ZIP/Postal Code
007874
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6300014
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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://vivli.org
Learn more about this trial
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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