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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

Primary Purpose

Healthy Volunteers (Meningococcal Infection)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MenACYW conjugate vaccine
MenACYW-135 conjugate vaccine
DTaP-IPV//Hib vaccine
Pneumococcal 13-valent conjugate vaccine
Pentavalent rotavirus vaccine
Hepatitis B vaccine
Measles, mumps, rubella (MMR) vaccine
Varicella vaccine
Hepatitis A vaccine
Sponsored by
Sanofi Pasteur, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthy Volunteers (Meningococcal Infection) focused on measuring Meningococcal meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine

Eligibility Criteria

42 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

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
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number :8400026
  • Investigational Site Number :8400003
  • Investigational Site Number :8400083
  • Investigational Site Number :8400011
  • Investigational Site Number :8400032
  • Investigational Site Number :8400031
  • Investigational Site Number :8400007
  • Investigational Site Number :8400092
  • Investigational Site Number :8400126
  • Investigational Site Number :8400095
  • Investigational Site Number :8400030
  • Investigational Site Number :8400076
  • Investigational Site Number :8400064
  • Investigational Site Number :8400077
  • Investigational Site Number :8400057
  • Investigational Site Number :8400014
  • Investigational Site Number :8400040
  • Investigational Site Number :8400063
  • Investigational Site Number :8400068
  • Investigational Site Number :8400001
  • Investigational Site Number :8400108
  • Investigational Site Number :8400022
  • Investigational Site Number :8400132
  • Investigational Site Number :8400008
  • Investigational Site Number :8400073
  • Investigational Site Number :8400106
  • Investigational Site Number :8400010
  • Investigational Site Number :8400043
  • Investigational Site Number :8400023
  • Investigational Site Number :8400025
  • Investigational Site Number :8400120
  • Investigational Site Number :8400004
  • Investigational Site Number :8400041
  • Investigational Site Number :8400080
  • Investigational Site Number :8400037
  • Investigational Site Number :8400039
  • Investigational Site Number :8400137
  • Investigational Site Number :8400100
  • Investigational Site Number :8400084
  • Investigational Site Number :8400002
  • Investigational Site Number :8400085
  • Investigational Site Number :8400047
  • Investigational Site Number :8400005
  • Investigational Site Number :8400110
  • Investigational Site Number :8400113
  • Investigational Site Number :8400033
  • Investigational Site Number :8400059
  • Investigational Site Number :8400065
  • Investigational Site Number :8400075
  • Investigational Site Number :8400079
  • Investigational Site Number :8400067
  • Investigational Site Number :8400109
  • Investigational Site Number :8400114
  • Investigational Site Number :8400053
  • Investigational Site Number :8400049
  • Investigational Site Number :8400128
  • Investigational Site Number :8400016
  • Investigational Site Number :8400035
  • Investigational Site Number :8400018
  • Investigational Site Number :8400024
  • Investigational Site Number :8400056
  • Investigational Site Number :8400029
  • Investigational Site Number :8400038
  • Investigational Site Number :8400036
  • Investigational Site Number :8400062
  • Investigational Site Number :6300116
  • Investigational Site Number :6300122
  • Investigational Site Number :6300015
  • Investigational Site Number :6300117
  • Investigational Site Number :6300140

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Group 1a

Group 1b

Group 2a

Group 2b

Arm Description

MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age

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

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

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

Outcomes

Primary Outcome Measures

Antibody titers above predefined thresholds against meningococcal serogroups A, C, Y, and W (Subgroup 1a and 2a)
Percentage of participants achieving a seroresponse, measured by the serum bactericidal assay using human complement (hSBA)
Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (group 1 and 2)
Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8, measured by hSBA

Secondary Outcome Measures

IgG antibody concentrations ≥ 10 milli-international units (mIU) / mL against hepatitis B
Percentage of participants who achieving IgG antibody concentrations ≥ predefined threshold of 10 mIU/mL
IgG antibody concentrations against hepatitis B
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations against polyribosyl-ribitol phosphate (PRP)
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations ≥ 0.15 and/or ≥ 1.0 µg/mL against PRP
Percentage of subjects achieving antibody concentrations ≥ predefined thresholds of 0.15 µg/mL and/or 1.0 µg/mL
Antibody concentrations above predefined threshold against diphteria and tetanus
% of participants with antibody concentrations ≥ established serostatus cut-off levels for diphteria and tetanus
Antibody concentrations against diphteria and tetanus
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody titers ≥ 1:8 against poliovirus types 1, 2, and 3
Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8
Antibody titers against poliovirus types 1,2,3
Antibody titers will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean titers (GMTs)
IgA antibody concentrations with ≥ 3-fold rise over baseline for antigens of 5 serogroups of rotavirus
Percentage of participants achieving IgA antibody concentrations ≥ predefined threshold of 3-fold rise over baseline
IgA antibody concentrations against antigens of 5 serogroups of rotavirus
Antibody concentrations will be measured by standard assays for the antigens contained in the rotavirus vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations against pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM])
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations above predefined threshold against pertussis (PT, FHA, PRN, FIM)
% of participants with antibody concentrations ≥ established seroresponse rate for pertussis
Antibody concentrations against antigens of 13-valent pneumococcal vaccine
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations above predefined thresholds for antigens of MMR vaccine
% of participants with antibody concentrations ≥ established serostatus cut-off levels for antigens in MMR vaccine
Antibody concentrations against antigens of MMR vaccine
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations against antigens of varicella vaccine
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Antibody concentrations above predefined thresholds for antigens of varicella vaccine
% of participants with antibody concentrations ≥ established serostatus cut-off levels for antigens in varicella vaccine
Antibody against meningococcal serogroups A, C, Y, and W
Antibody titers will be measured by hSBA and expressed as geometric mean titers (GMTs)
Antibody titers above pre-defined thresholds for meningococcal serogroups A, C, Y, and W
% of participants achieving antibody titers ≥ predefined thresholds, measured by hSBA

Full Information

First Posted
May 15, 2018
Last Updated
January 3, 2023
Sponsor
Sanofi Pasteur, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT03537508
Brief Title
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
Official Title
A Phase III, Partially Modified Double-blind, Randomized, Parallel-group, Active-controlled, Multi-center Study to Compare the Immunogenicity and Describe the Safety of MenACYW Conjugate Vaccine and MENVEO® When Administered Concomitantly With Routine Pediatric Vaccines to Healthy Infants and Toddlers in the United States
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
October 10, 2024 (Anticipated)
Study Completion Date
October 10, 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
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The duration of each subject's participation in the trial will be approximately 16 to 19 months (Subgroup 1a) and 19 to 22 months (Subgroup 1b and Group 2), which includes a safety follow up contact at 6 months after the last vaccinations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers (Meningococcal Infection)
Keywords
Meningococcal meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study is conducted 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.
Allocation
Randomized
Enrollment
2628 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1a
Arm Type
Experimental
Arm Description
MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age
Arm Title
Group 1b
Arm Type
Experimental
Arm Description
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
Arm Title
Group 2a
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group 2b
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
MenACYW conjugate vaccine
Intervention Description
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
Intervention Type
Biological
Intervention Name(s)
MenACYW-135 conjugate vaccine
Other Intervention Name(s)
MENVEO®
Intervention Description
Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV//Hib vaccine
Other Intervention Name(s)
Pentacel®
Intervention Description
DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 13-valent conjugate vaccine
Other Intervention Name(s)
PREVNAR 13®
Intervention Description
Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Pentavalent rotavirus vaccine
Other Intervention Name(s)
RotaTeq®
Intervention Description
Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
Intervention Type
Biological
Intervention Name(s)
Hepatitis B vaccine
Other Intervention Name(s)
ENGERIX-B®
Intervention Description
Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Measles, mumps, rubella (MMR) vaccine
Other Intervention Name(s)
M-M-R® II
Intervention Description
MMR vaccine at 12 months of age, Subcutaneous
Intervention Type
Biological
Intervention Name(s)
Varicella vaccine
Other Intervention Name(s)
VARIVAX®
Intervention Description
Varicella vaccine at 12 months of age
Intervention Type
Biological
Intervention Name(s)
Hepatitis A vaccine
Other Intervention Name(s)
HAVRIX®
Intervention Description
Hepatitis A vaccine at 15 to 18 months of age
Primary Outcome Measure Information:
Title
Antibody titers above predefined thresholds against meningococcal serogroups A, C, Y, and W (Subgroup 1a and 2a)
Description
Percentage of participants achieving a seroresponse, measured by the serum bactericidal assay using human complement (hSBA)
Time Frame
D0 and 30 days after the fourth meningococcal vaccination for subgroup 1a and 2a
Title
Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (group 1 and 2)
Description
Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8, measured by hSBA
Time Frame
30 days after vaccination at 6 months of age for group 1 and 2
Secondary Outcome Measure Information:
Title
IgG antibody concentrations ≥ 10 milli-international units (mIU) / mL against hepatitis B
Description
Percentage of participants who achieving IgG antibody concentrations ≥ predefined threshold of 10 mIU/mL
Time Frame
30 days after vaccination at 6 months of age for group 1 and 2
Title
IgG antibody concentrations against hepatitis B
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after vaccination at 6 months of age for group 1 and group 2
Title
Antibody concentrations against polyribosyl-ribitol phosphate (PRP)
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after vaccination at 6 months, before and 30 days after 15-months vaccination for subgroup 1b and 2b
Title
Antibody concentrations ≥ 0.15 and/or ≥ 1.0 µg/mL against PRP
Description
Percentage of subjects achieving antibody concentrations ≥ predefined thresholds of 0.15 µg/mL and/or 1.0 µg/mL
Time Frame
30 days after vaccination at 6 months of age for group 1 and group 2, before and 30 days after vaccination at 15 months of age for subgroup 1b and 2b
Title
Antibody concentrations above predefined threshold against diphteria and tetanus
Description
% of participants with antibody concentrations ≥ established serostatus cut-off levels for diphteria and tetanus
Time Frame
30 days after vaccination at 6 months for group 1 and 2, 30 days after 15-months vaccination for subgroup 1b and 2b
Title
Antibody concentrations against diphteria and tetanus
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after vaccination at 6 months for group 1 and 2, 30 days after 15-months vaccination for subgroup 1b and 2b
Title
Antibody titers ≥ 1:8 against poliovirus types 1, 2, and 3
Description
Percentage of participants achieving antibody titers ≥ predefined threshold of 1:8
Time Frame
30 days after vaccination at 6 months for group 1 and group 2, 30 days after vaccination at 15 months of age for subgroup 1b and 2b
Title
Antibody titers against poliovirus types 1,2,3
Description
Antibody titers will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean titers (GMTs)
Time Frame
30 days after vaccination at 6 months of age for group 1 and group 2, 30 days after vaccination at 15 months of age for subgroup 1b and 2b
Title
IgA antibody concentrations with ≥ 3-fold rise over baseline for antigens of 5 serogroups of rotavirus
Description
Percentage of participants achieving IgA antibody concentrations ≥ predefined threshold of 3-fold rise over baseline
Time Frame
D0 and 30 days after vaccination at 6 months of age for group 1 and 2
Title
IgA antibody concentrations against antigens of 5 serogroups of rotavirus
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the rotavirus vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
D0 and 30 days after vaccination at 6 months of age for group 1 and 2
Title
Antibody concentrations against pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], pertactin [PRN], fimbriae types 2 and 3 [FIM])
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
D0 and 30 days after vaccination at 6- months of age for group 1 and 2, before and after the 15-months vaccinations for subgroup 1b and 2b
Title
Antibody concentrations above predefined threshold against pertussis (PT, FHA, PRN, FIM)
Description
% of participants with antibody concentrations ≥ established seroresponse rate for pertussis
Time Frame
before and after the vaccination at 15 months of age for subgroup 1b and 2b
Title
Antibody concentrations against antigens of 13-valent pneumococcal vaccine
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after vaccination at 6 months for group 1 and 2, 30 days after vaccination at 12 months for subgroup 1a and 2a
Title
Antibody concentrations above predefined thresholds for antigens of MMR vaccine
Description
% of participants with antibody concentrations ≥ established serostatus cut-off levels for antigens in MMR vaccine
Time Frame
30 days after the 12-month vaccination for subgroup 1a and 2a
Title
Antibody concentrations against antigens of MMR vaccine
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after the 12-month vaccination for subgroup 1a and 2a
Title
Antibody concentrations against antigens of varicella vaccine
Description
Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine and expressed as geometric mean concentrations (GMCs)
Time Frame
30 days after the 12-month vaccination for subgroup 1a and 2a
Title
Antibody concentrations above predefined thresholds for antigens of varicella vaccine
Description
% of participants with antibody concentrations ≥ established serostatus cut-off levels for antigens in varicella vaccine
Time Frame
30 days after the 12-month vaccination for subgroup 1a and 2a
Title
Antibody against meningococcal serogroups A, C, Y, and W
Description
Antibody titers will be measured by hSBA and expressed as geometric mean titers (GMTs)
Time Frame
D0, 30 days after the 6-month age vaccination for group 1 and 2, before and 30 days after the 12-month vaccination for subgroup 1a and 2a, before and after the 15-month vaccination for subgroup 1b
Title
Antibody titers above pre-defined thresholds for meningococcal serogroups A, C, Y, and W
Description
% of participants achieving antibody titers ≥ predefined thresholds, measured by hSBA
Time Frame
30 days after the 6-month age vaccination for group 1 and 2, before and 30 days after the 12-month vaccination for subgroup 1a and 2a, before and after the 15-month vaccination for subgroup 1b

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Days
Maximum Age & Unit of Time
89 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur, a Sanofi Company
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number :8400026
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Investigational Site Number :8400003
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Investigational Site Number :8400083
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Investigational Site Number :8400011
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Investigational Site Number :8400032
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Investigational Site Number :8400031
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Investigational Site Number :8400007
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Investigational Site Number :8400092
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Investigational Site Number :8400126
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Investigational Site Number :8400095
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Investigational Site Number :8400030
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Investigational Site Number :8400076
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Investigational Site Number :8400064
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Investigational Site Number :8400077
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Investigational Site Number :8400057
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33013
Country
United States
Facility Name
Investigational Site Number :8400014
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Investigational Site Number :8400040
City
Homestead
State/Province
Florida
ZIP/Postal Code
33030
Country
United States
Facility Name
Investigational Site Number :8400063
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
Facility Name
Investigational Site Number :8400068
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Investigational Site Number :8400001
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Investigational Site Number :8400108
City
Orlando
State/Province
Florida
ZIP/Postal Code
00000
Country
United States
Facility Name
Investigational Site Number :8400022
City
Palmetto Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Facility Name
Investigational Site Number :8400132
City
Tampa
State/Province
Florida
ZIP/Postal Code
33617
Country
United States
Facility Name
Investigational Site Number :8400008
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Investigational Site Number :8400073
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number :8400106
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Investigational Site Number :8400010
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Investigational Site Number :8400043
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40243
Country
United States
Facility Name
Investigational Site Number :8400023
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
Investigational Site Number :8400025
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number :8400120
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Investigational Site Number :8400004
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Investigational Site Number :8400041
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States
Facility Name
Investigational Site Number :8400080
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Investigational Site Number :8400037
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
Investigational Site Number :8400039
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number :8400137
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Investigational Site Number :8400100
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Investigational Site Number :8400084
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Facility Name
Investigational Site Number :8400002
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
Investigational Site Number :8400085
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Investigational Site Number :8400047
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
Investigational Site Number :8400005
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Investigational Site Number :8400110
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Investigational Site Number :8400113
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
Investigational Site Number :8400033
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Facility Name
Investigational Site Number :8400059
City
Austin
State/Province
Texas
ZIP/Postal Code
78726
Country
United States
Facility Name
Investigational Site Number :8400065
City
Dallas
State/Province
Texas
ZIP/Postal Code
75218
Country
United States
Facility Name
Investigational Site Number :8400075
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Investigational Site Number :8400079
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107-2699
Country
United States
Facility Name
Investigational Site Number :8400067
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0163
Country
United States
Facility Name
Investigational Site Number :8400109
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Investigational Site Number :8400114
City
Houston
State/Province
Texas
ZIP/Postal Code
77087
Country
United States
Facility Name
Investigational Site Number :8400053
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Investigational Site Number :8400049
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site Number :8400128
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Facility Name
Investigational Site Number :8400016
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Investigational Site Number :8400035
City
Kaysville
State/Province
Utah
ZIP/Postal Code
84037
Country
United States
Facility Name
Investigational Site Number :8400018
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Investigational Site Number :8400024
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Investigational Site Number :8400056
City
Provo
State/Province
Utah
ZIP/Postal Code
84064
Country
United States
Facility Name
Investigational Site Number :8400029
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Facility Name
Investigational Site Number :8400038
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Investigational Site Number :8400036
City
Syracuse
State/Province
Utah
ZIP/Postal Code
84075-9645
Country
United States
Facility Name
Investigational Site Number :8400062
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Investigational Site Number :6300116
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Facility Name
Investigational Site Number :6300122
City
Guayama
ZIP/Postal Code
000784
Country
Puerto Rico
Facility Name
Investigational Site Number :6300015
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Investigational Site Number :6300117
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Investigational Site Number :6300140
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico

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 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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