Clinical trial NCT03691610: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers (Meningococcal Infection)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-10-02
Enrollment: 950
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
timeFrame: Baseline (Day 0) and 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO, maximum of 14 months
Secondary outcomes:
measure: Infants Groups 1 and 2: Percentage of Participants Who Achieved Antibody Titer (Seroprotection) >=1:8 by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or MENVEO
timeFrame: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
timeFrame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Infants Groups 1 and 2: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
timeFrame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >=1:4 to >= 1:128
timeFrame: PPAS1: At 30 days post first dose (6 to 7 MoA); PPAS2: At Baseline (pre-dose on Day 0) and 30 days post second dose (12 to 13 MoA); and PPAS3: At 6 months post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Infants Groups 1 and 2: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: PPAS1: At 30 days post first dose (6 to 7 MoA); and PPAS2: At 30 days post second dose (12 to 13 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Infants Groups 1 and 2: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post First Dose of MenACYW Conjugate Vaccine or MENVEO
timeFrame: At 30 days post first dose (6 to 7 MoA) of MenACYW conjugate vaccine or MENVEO
measure: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 and >= 1:8
timeFrame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
measure: Toddlers Groups 3 and 4: Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y
timeFrame: Baseline (Day 0) and 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
measure: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 1:4 to >= 1:128
timeFrame: Baseline (Day 0) and at 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
measure: Toddlers Groups 3 and 4: Percentage of Participants With hSBA Antibody Titer >= 4-Fold Rise From Pre-Vaccination to Post-Vaccination
timeFrame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
measure: Toddlers Groups 3 and 4: Percentage of Participants With Vaccine Seroresponse Measured by hSBA at 30 Days Post Second Dose of MenACYW Conjugate Vaccine or Menactra
timeFrame: At 30 days post second dose (20 to 23 MoA) of MenACYW conjugate vaccine or Menactra
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics Site Number : 8400036
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates Site Number : 8400009
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC - Phoenix Site Number : 8400013
state: Arizona
city: Anaheim
country: United States
facility: Emmaus Research Center, Inc Site Number : 8400019
state: California
city: Bellflower
country: United States
facility: Coast Clinical Trials, LLC Site Number : 8400073
state: California
city: Gardena
country: United States
facility: Matrix Clinical Research Site Number : 8400082
state: California
city: Madera
country: United States
facility: Madera Family Med Group Site Number : 8400065
state: California
city: Homestead
country: United States
facility: Next Phase Research Alliance Site Number : 8400044
state: Florida
city: Land O' Lakes
country: United States
facility: PAS Research Site Number : 8400101
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research Site Number : 8400021
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research Site Number : 8400034
state: Florida
city: Miami
country: United States
facility: Y and L Advance Health Care, Inc D/B/A Elite Clinical Res Site Number : 8400046
state: Florida
city: Miami
country: United States
facility: Biomedical Research LLC Site Number : 8400041
state: Florida
city: Tampa
country: United States
facility: PAS Research Site Number : 8400059
state: Florida
city: Roswell
country: United States
facility: Omega Pediatrics Site Number : 8400093
state: Georgia
city: Idaho Falls
country: United States
facility: Snake River Research, PLLC Site Number : 8400058
state: Idaho
city: Chicago
country: United States
facility: Eagle Clinical Research Site Number : 8400094
state: Illinois
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics Site Number : 8400039
state: Kentucky
city: Louisville
country: United States
facility: All Children Pediatrics Site Number : 8400024
state: Kentucky
city: Baton Rouge
country: United States
facility: Meridian Clinical Research, LLC Site Number : 8400035
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research Site Number : 8400016
state: Louisiana
city: Shreveport
country: United States
facility: Willis-Knighton Physician Network Site Number : 8400075
state: Louisiana
city: Baltimore
country: United States
facility: Victory Clinical Research Site Number : 8400026
state: Maryland
city: Fall River
country: United States
facility: Pediatric Associates of Fall River Site Number : 8400112
state: Massachusetts
city: Bridgeton
country: United States
facility: Craig Spiegel, MD Site Number : 8400023
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research Site Number : 8400097
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Childrens Health Research Institute Site Number : 8400111
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Childrens Health Research Institute Site Number : 8400117
state: Nebraska
city: Albuquerque
country: United States
facility: MedPharmics Inc Site Number : 8400006
state: New Mexico
city: New York
country: United States
facility: Advantage Clinical Trials Site Number : 8400069
state: New York
city: Wilmington
country: United States
facility: Wilmington Health Site Number : 8400054
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research Site Number : 8400022
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research Site Number : 8400008
state: Ohio
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences Site Number : 8400110
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research Site Number : 8400010
state: Oregon
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion Site Number : 8400025
state: Pennsylvania
city: Hermitage
country: United States
facility: Kid's Way Pediatrics Site Number : 8400015
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research Charleston Site Number : 8400002
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research Charleston Site Number : 8400011
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research Site Number : 8400118
state: South Carolina
city: Tullahoma
country: United States
facility: Pediatric Clinical Trials Tullahoma Site Number : 8400106
state: Tennessee
city: Beaumont
country: United States
facility: Tekton Research Site Number : 8400047
state: Texas
city: Dickinson
country: United States
facility: Mercury Clinical Research, Inc. Site Number : 8400088
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network - 7080 Southwest Fwy Site Number : 8400037
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, Inc. Site Number : 8400040
state: Texas
city: Guayama
country: Puerto Rico
facility: Investigational Site Number : 6300102
city: San Juan
country: Puerto Rico
facility: Investigational Site Number : 6300014
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: