Clinical trial NCT03673462: Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
Official title: A Randomized Study to Describe the Safety 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: 2018-09-17
Enrollment: 2797
Sex: ALL
Minimum age (years): 42
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Detailed description: Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.

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 was signed and dated by the parent(s) or guardian (and by an independent witness if required by local regulations).
* Participant and parent/guardian were able to attend all scheduled visits and complied 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 might 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).
* Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and 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 was 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, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection/disease.
* At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
* History of intussusception.
* History of any neurologic disorders, including 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.
* 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 degree Celsius \[\>= 100.4-degree Fahrenheit\]). 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
timeFrame: Within 30 minutes post-any vaccination
measure: Number of Participants With Solicited Injection Site Reactions
timeFrame: Within 7 days post any vaccination
measure: Number of Participants With Solicited Systemic Reactions
timeFrame: Within 7 days post-any vaccination
measure: Number of Participants With Unsolicited Adverse Events
timeFrame: Within 30 days post any vaccination
measure: Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
timeFrame: From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)
measure: Number of Participants With Medically Attended Adverse Event (MAAEs)
timeFrame: From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates-Site Number:8400049
state: Alabama
city: Dothan
country: United States
facility: Southeastern Pediatric Associates-Site Number:8400034
state: Alabama
city: Phoenix
country: United States
facility: MedPharmics, LLC - Phoenix-Site Number:8400043
state: Arizona
city: Fayetteville
country: United States
facility: Northwest Arkansas Pediatric Clinic-Site Number:8400042
state: Arkansas
city: Hot Springs
country: United States
facility: HealthStar Research, LLC-Site Number:8400100
state: Arkansas
city: Jonesboro
country: United States
facility: The Children's Clinic of Jonesboro, PA-Site Number:8400059
state: Arkansas
city: Anaheim
country: United States
facility: Emmaus Research Center, Inc-Site Number:8400057
state: California
city: Banning
country: United States
facility: Advanced Clinical Research - Rancho Paseo-Site Number:8400087
state: California
city: Downey
country: United States
facility: Premier Health Research Center, LLC-Site Number:8400039
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC-Site Number:8400056
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel-Site Number:8400051
state: California
city: West Covina
country: United States
facility: Center for Clinical Trials of San Gabriel-Site Number:8400099
state: California
city: Colorado Springs
country: United States
facility: Optum Clinical Research-Site Number:8400076
state: Colorado
city: Thornton
country: United States
facility: IMMUNOe Research Centers - Thornton-Site Number:8400022
state: Colorado
city: DeLand
country: United States
facility: Avail Clinical Research, LLC-Site Number:8400055
state: Florida
city: Fort Myers
country: United States
facility: Advanced Research for Health Improvement-Site Number:8400096
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials-Site Number:8400003
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research-Site Number:8400018
state: Florida
city: Miami
country: United States
facility: De Armas Research Center,-Site Number:8400088
state: Florida
city: Miami
country: United States
facility: Healthy Life Research-Site Number:8400075
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates-Site Number:8400032
state: Florida
city: Naples
country: United States
facility: Advanced Research for Health Improvement-Site Number:8400005
state: Florida
city: Macon
country: United States
facility: Meridian Clinical Research-Site Number:8400114
state: Georgia
city: Mishawaka
country: United States
facility: MOC Research-Site Number:8400095
state: Indiana
city: Bardstown
country: United States
facility: Kentucky Pediatics / Adult Research-Site Number:8400044
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville-Site Number:8400082
state: Kentucky
city: Louisville
country: United States
facility: Brownsboro Park Pediatrics-Site Number:8400040
state: Kentucky
city: Louisville
country: United States
facility: All Children Pediatrics-Site Number:8400069
state: Kentucky
city: Metairie
country: United States
facility: MedPharmics-Site Number:8400048
state: Louisiana
city: Fall River
country: United States
facility: Pediatric Associates of Fall River-Site Number:8400103
state: Massachusetts
city: Biloxi
country: United States
facility: MedPharmics Biloxi-Site Number:8400052
state: Mississippi
city: Bridgeton
country: United States
facility: Craig Spiegel, MD-Site Number:8400067
state: Missouri
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research-Site Number:8400080
state: Missouri
city: Lincoln
country: United States
facility: Midwest Childrens Health Research Institute-Site Number:8400060
state: Nebraska
city: Rochester
country: United States
facility: Legacy Pediatrics-Site Number:8400004
state: New York
city: Greensboro
country: United States
facility: Medication Management-Site Number:8400072
state: North Carolina
city: Winston-Salem
country: United States
facility: Ford, Simpson, Lively & Rice Pediatrics-Site Number:8400021
state: North Carolina
city: Dayton
country: United States
facility: Ohio Pediatric Research-Site Number:8400064
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research-Site Number:8400033
state: Ohio
city: South Euclid
country: United States
facility: Senders Pediatrics-Site Number:8400061
state: Ohio
city: Bethany
country: United States
facility: The Children's Center Rehabilitation Hospital-Site Number:8400104
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University - Center for Health Sciences-Site Number:8400008
state: Oklahoma
city: Gresham
country: United States
facility: Cyn3rgy Research-Site Number:8400035
state: Oregon
city: Barnwell
country: United States
facility: Rainbow Pediatrics-Site Number:8400074
state: South Carolina
city: Charleston
country: United States
facility: Coastal Pediatric Research Charleston-Site Number:8400037
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston, LLC-Site Number:8400102
state: South Carolina
city: North Charleston
country: United States
facility: Palmetto Pediatrics, PA-Site Number:8400089
state: South Carolina
city: Bristol
country: United States
facility: PMG Research-Bristol-Site Number:8400009
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group, Pediatrics at Stone Plaza-Site Number:8400015
state: Tennessee
city: Tullahoma
country: United States
facility: Pediatric Clinical Trials Tullahoma-Site Number:8400062
state: Tennessee
city: Austin
country: United States
facility: ARC Clinical Research at Wilson Parke-Site Number:8400071
state: Texas
city: Buda
country: United States
facility: Benchmark Research - Buda-Site Number:8400016
state: Texas
city: Corpus Christi
country: United States
facility: Crossroads Clinical Research-Site Number:8400058
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo-Site Number:8400011
state: Texas
city: San Antonio
country: United States
facility: Southwest Children's Research Associates, P.A.-Site Number:8400002
state: Texas
city: Clinton
country: United States
facility: Tanner Clinic-Site Number:8400079
state: Utah
city: Kaysville
country: United States
facility: Wee Care Pediatrics-Site Number:8400065
state: Utah
city: Murray
country: United States
facility: Murray Pediatrics-Site Number:8400019
state: Utah
city: Orem
country: United States
facility: Utah Valley Pediatrics - Timpanogos-Site Number:8400038
state: Utah
city: Provo
country: United States
facility: Pediatric Care-Site Number:8400045
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research-Site Number:8400053
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Research-South-Site Number:8400036
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center-Site Number:8400068
state: Utah
city: South Jordan
country: United States
facility: J Lewis Research Inc-Site Number:8400050
state: Utah
city: Syracuse
country: United States
facility: Alliance for Multispecialty Research Syracuse-Site Number:8400066
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Medical Research of Charlottesville-Site Number:8400077
state: Virginia
city: Marshfield
country: United States
facility: Marshfield Clinic-Site Number:8400054
state: Wisconsin
city: San Juan
country: Puerto Rico
facility: Investigational Site Number :6300014
city: San Juan
country: Puerto Rico
facility: Investigational Site Number :6300108
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: