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CompletedNCT03673462MET41Updated Dec 14, 2023Results posted

Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

A Phase 3 interventional study of Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) in Healthy Volunteers (Meningococcal Infection), sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 69 sites in 2 countries. Open to participants aged 42 Days to 89 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-14.

Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,797
Allocation
Randomized
Ages
42 Days to 89 Days
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Healthy Volunteers (Meningococcal Infection)
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 2,797 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.

Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
42 Days to 89 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,797 participants (actual)

Study arms

  • Experimental
    Group 1: MenACYW Conjugate Vaccine

    Healthy infants aged greater than equal to (\>=) 42 to less than equal to (\<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) · Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine · Biological: Pneumococcal 13-valent Conjugate Vaccine · Biological: Rotavirus Vaccine · Biological: Hepatitis B Vaccine · Biological: Measles, Mumps, and Rubella Virus Vaccine · Biological: Varicella Virus Vaccine

  • Active comparator
    Group 2: MENVEO®

    Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.

    Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) · Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine · Biological: Pneumococcal 13-valent Conjugate Vaccine · Biological: Rotavirus Vaccine · Biological: Hepatitis B Vaccine · Biological: Measles, Mumps, and Rubella Virus Vaccine · Biological: Varicella Virus Vaccine

Interventions

  • BiologicalMeningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)

    Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

  • BiologicalMeningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)

    Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

  • BiologicalDiphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine

    Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

  • BiologicalPneumococcal 13-valent Conjugate Vaccine

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

  • BiologicalRotavirus Vaccine

    Pharmaceutical form: Oral solution Route of administration: Oral

  • BiologicalHepatitis B Vaccine

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

  • BiologicalMeasles, Mumps, and Rubella Virus Vaccine

    Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

  • BiologicalVaricella Virus Vaccine

    Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

06

What researchers measure

Primary outcomes

  1. Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

    An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: Within 30 minutes post-any vaccination

  2. Number of Participants With Solicited Injection Site Reactions

    A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: Within 7 days post any vaccination

  3. Number of Participants With Solicited Systemic Reactions

    A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: Within 7 days post-any vaccination

  4. Number of Participants With Unsolicited Adverse Events

    An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: Within 30 days post any vaccination

  5. Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: 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)

  6. Number of Participants With Medically Attended Adverse Event (MAAEs)

    A MAAE was defined as a new onset of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a health care provider's office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol.

    Time frame: 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)

07

Results

Posted Oct 5, 2023

Participant flow

Study was conducted at 75 sites in Puerto Rico and United States from 17 September 2018 to 16 March 2023.

Participant flow — Overall Study
MilestoneGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Started2099698
Safety analysis set (safas)2080697
Vaccinated at 2 months2080695
Vaccinated at 4 months2005663
Vaccinated at 6 months1951648
Vaccinated at 12 months1838623
Completed1799611
Not completed30087
Withdrew: Adverse event111
Withdrew: Protocol violation2511
Withdrew: Withdrawal by parent/guardian16256
Withdrew: Lost to follow-up10219

Outcome measures

PrimaryNumber of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
Within 30 minutes post-any vaccination
Reported as:
Count of participants · Participants
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
ParticipantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)72
PrimaryNumber of Participants With Solicited Injection Site Reactions

A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
Within 7 days post any vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Injection Site Reactions
ParticipantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
MenACYW or MENVEO: Injection site Tenderness1501499
MenACYW or MENVEO: Injection site Erythema826257
MenACYW or MENVEO: Injection site Swelling557170
PENTACEL: Injection site Tenderness1388456
PENTACEL: Injection site Erythema770255
PENTACEL: Injection site Swelling562178
PREVNAR 13: Injection site Tenderness1464496
PREVNAR 13: Injection site Erythema889298
PREVNAR 13: Injection site Swelling656206
ENGERIX-B: Injection site Tenderness1199395
ENGERIX-B: Injection site Erythema539192
ENGERIX-B: Injection site Swelling347115
M-M-R II: Injection site Tenderness786268
M-M-R II: Injection site Erythema409130
M-M-R II: Injection site Swelling22171
VARIVAX: Injection site Tenderness724252
VARIVAX: Injection site Erythema364129
VARIVAX: Injection site Swelling20870
PrimaryNumber of Participants With Solicited Systemic Reactions

A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
Within 7 days post-any vaccination
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic Reactions
ParticipantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Fever724219
Vomiting542163
Crying abnormal1437478
Drowsiness1430475
Appetite lost1015350
Irritability1604536
PrimaryNumber of Participants With Unsolicited Adverse Events

An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
Within 30 days post any vaccination
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited Adverse Events
ParticipantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Number of Participants With Unsolicited Adverse Events1352437
PrimaryNumber of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
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)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)
ParticipantsGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
SAE10821
AESI191
PrimaryNumber of Participants With Medically Attended Adverse Event (MAAEs)

A MAAE was defined as a new onset of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a health care provider's office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol.

Time frame:
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)
Reported as:
Count of participants · Participants
Number of Participants With Medically Attended Adverse Event (MAAEs)
ParticipantsGroup 1: MenACYW Conjugate VaccineMENVEO®
Number of Participants With Medically Attended Adverse Event (MAAEs)1581526

Adverse events

Collected over Unsolicited AE: within 30 days post-any vaccination. Solicited Reactions (SR): within 7 days post-any vaccination. SAE: from day of first vaccination (i.e., at the age of 2 months) up to 6 months post last vaccination (i.e., up to the age of 18 months). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: MenACYW Conjugate Vaccine3/2,080 (0.1%)108/2,080 (5.2%)1,889/2,080 (90.8%)
Group 2: MENVEO®0/697 (0%)21/697 (3%)642/697 (92.1%)
Most frequent serious events
Showing 10 of 79
Most frequent serious events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Febrile ConvulsionNervous system disorders15/20801/697
Respiratory Syncytial Virus InfectionInfections and infestations11/20801/697
BronchiolitisInfections and infestations9/20801/697
DehydrationMetabolism and nutrition disorders5/20803/697
Respiratory Syncytial Virus BronchiolitisInfections and infestations7/20801/697
Croup InfectiousInfections and infestations0/20802/697
Rhinovirus InfectionInfections and infestations2/20802/697
Gastroenteritis ViralInfections and infestations4/20800/697
Gastrooesophageal Reflux DiseaseGastrointestinal disorders3/20800/697
Urinary Tract InfectionInfections and infestations3/20800/697
Most frequent other events
Showing 10 of 16
Most frequent other events
EventGroup 1: MenACYW Conjugate VaccineGroup 2: MENVEO®
Injection Site PainGeneral disorders1619/2080538/697
IrritabilityPsychiatric disorders1604/2080538/697
CryingGeneral disorders1439/2080479/697
SomnolenceNervous system disorders1430/2080475/697
Injection Site ErythemaGeneral disorders1129/2080380/697
Decreased AppetiteMetabolism and nutrition disorders1017/2080351/697
Injection Site SwellingGeneral disorders871/2080282/697
PyrexiaGeneral disorders810/2080248/697
VomitingGastrointestinal disorders579/2080172/697
Injection Site BruisingGeneral disorders353/2080107/697

Baseline characteristics

Analysis was performed on all randomized participants.

Age, Continuous
Age, Continuous(days)Group 1: MenACYW Conjugate VaccineGroup 2 MENVEO®Total
Mean64.7 ± 6.6364.9 ± 6.7764.7 ± 6.67
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: MenACYW Conjugate VaccineGroup 2 MENVEO®Total
Female9983361334
Male11013621463
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: MenACYW Conjugate VaccineGroup 2 MENVEO®Total
American Indian or Alaska Native808
Asian281240
Native Hawaiian or Other Pacific Islander10515
Black or African American21067277
White17195802299
More than one race10231133
Unknown or Not Reported22325
08

Study locations

69 sites
  • Birmingham Pediatric Associates-Site Number:8400049
    Birmingham, Alabama 35205, United States
  • Southeastern Pediatric Associates-Site Number:8400034
    Dothan, Alabama 36305, United States
  • MedPharmics, LLC - Phoenix-Site Number:8400043
    Phoenix, Arizona 85015, United States
  • Northwest Arkansas Pediatric Clinic-Site Number:8400042
    Fayetteville, Arkansas 72703, United States
  • HealthStar Research, LLC-Site Number:8400100
    Hot Springs, Arkansas 71913, United States
  • The Children's Clinic of Jonesboro, PA-Site Number:8400059
    Jonesboro, Arkansas 72401, United States
  • Emmaus Research Center, Inc-Site Number:8400057
    Anaheim, California 92804, United States
  • Advanced Clinical Research - Rancho Paseo-Site Number:8400087
    Banning, California 92220, United States
  • Premier Health Research Center, LLC-Site Number:8400039
    Downey, California 90240, United States
  • Center for Clinical Trials, LLC-Site Number:8400056
    Paramount, California 90723, United States
  • Center for Clinical Trials of San Gabriel-Site Number:8400051
    West Covina, California 91790, United States
  • Center for Clinical Trials of San Gabriel-Site Number:8400099
    West Covina, California 91790, United States
  • Optum Clinical Research-Site Number:8400076
    Colorado Springs, Colorado 80922, United States
  • IMMUNOe Research Centers - Thornton-Site Number:8400022
    Thornton, Colorado 80233, United States
  • Avail Clinical Research, LLC-Site Number:8400055
    DeLand, Florida 32720-0834, United States
  • Advanced Research for Health Improvement-Site Number:8400096
    Fort Myers, Florida 33907, United States
  • Sarkis Clinical Trials-Site Number:8400003
    Gainesville, Florida 32607, United States
  • Crystal Biomedical Research-Site Number:8400018
    Miami Lakes, Florida 33014, United States
  • De Armas Research Center,-Site Number:8400088
    Miami, Florida 33174, United States
  • Healthy Life Research-Site Number:8400075
    Miami, Florida 33175, United States
  • Acevedo Clinical Research Associates-Site Number:8400032
    Miami, Florida 33186, United States
  • Advanced Research for Health Improvement-Site Number:8400005
    Naples, Florida 8400011, United States
  • Meridian Clinical Research-Site Number:8400114
    Macon, Georgia 31210, United States
  • MOC Research-Site Number:8400095
    Mishawaka, Indiana 46544, United States
  • Kentucky Pediatics / Adult Research-Site Number:8400044
    Bardstown, Kentucky 40004, United States
  • University of Louisville-Site Number:8400082
    Louisville, Kentucky 40202, United States
  • Brownsboro Park Pediatrics-Site Number:8400040
    Louisville, Kentucky 40207, United States
  • All Children Pediatrics-Site Number:8400069
    Louisville, Kentucky 40243, United States
  • MedPharmics-Site Number:8400048
    Metairie, Louisiana 70006, United States
  • Pediatric Associates of Fall River-Site Number:8400103
    Fall River, Massachusetts 02721, United States
  • MedPharmics Biloxi-Site Number:8400052
    Biloxi, Mississippi 39531, United States
  • Craig Spiegel, MD-Site Number:8400067
    Bridgeton, Missouri 63044, United States
  • Center for Pharmaceutical Research-Site Number:8400080
    Kansas City, Missouri 64114, United States
  • Midwest Childrens Health Research Institute-Site Number:8400060
    Lincoln, Nebraska 68504, United States
  • Legacy Pediatrics-Site Number:8400004
    Rochester, New York 14618, United States
  • Medication Management-Site Number:8400072
    Greensboro, North Carolina 27360, United States
  • Ford, Simpson, Lively & Rice Pediatrics-Site Number:8400021
    Winston-Salem, North Carolina 27103, United States
  • Ohio Pediatric Research-Site Number:8400064
    Dayton, Ohio 45414, United States
  • PriMed Clinical Research-Site Number:8400033
    Dayton, Ohio 45419, United States
  • Senders Pediatrics-Site Number:8400061
    South Euclid, Ohio 44121, United States
  • The Children's Center Rehabilitation Hospital-Site Number:8400104
    Bethany, Oklahoma 73008, United States
  • Oklahoma State University - Center for Health Sciences-Site Number:8400008
    Tulsa, Oklahoma 74127, United States
  • Cyn3rgy Research-Site Number:8400035
    Gresham, Oregon 97030, United States
  • Rainbow Pediatrics-Site Number:8400074
    Barnwell, South Carolina 29812, United States
  • Coastal Pediatric Research Charleston-Site Number:8400037
    Charleston, South Carolina 29414, United States
  • PMG Research of Charleston, LLC-Site Number:8400102
    Mount Pleasant, South Carolina 29464, United States
  • Palmetto Pediatrics, PA-Site Number:8400089
    North Charleston, South Carolina 29406, United States
  • PMG Research-Bristol-Site Number:8400009
    Bristol, Tennessee 37620, United States
  • Holston Medical Group, Pediatrics at Stone Plaza-Site Number:8400015
    Kingsport, Tennessee 37660, United States
  • Pediatric Clinical Trials Tullahoma-Site Number:8400062
    Tullahoma, Tennessee 37388, United States
  • ARC Clinical Research at Wilson Parke-Site Number:8400071
    Austin, Texas 78726, United States
  • Benchmark Research - Buda-Site Number:8400016
    Buda, Texas 78610, United States
  • Crossroads Clinical Research-Site Number:8400058
    Corpus Christi, Texas 78413, United States
  • Benchmark Research - San Angelo-Site Number:8400011
    San Angelo, Texas 76904, United States
  • Southwest Children's Research Associates, P.A.-Site Number:8400002
    San Antonio, Texas 78229, United States
  • Tanner Clinic-Site Number:8400079
    Clinton, Utah 84015, United States
  • Wee Care Pediatrics-Site Number:8400065
    Kaysville, Utah 84037, United States
  • Murray Pediatrics-Site Number:8400019
    Murray, Utah 84107, United States
  • Utah Valley Pediatrics - Timpanogos-Site Number:8400038
    Orem, Utah 84057, United States
  • Pediatric Care-Site Number:8400045
    Provo, Utah 84064, United States
  • J. Lewis Research-Site Number:8400053
    Salt Lake City, Utah 84109, United States
  • Foothill Family Research-South-Site Number:8400036
    Salt Lake City, Utah 84121, United States
  • Copperview Medical Center-Site Number:8400068
    South Jordan, Utah 84095, United States
  • J Lewis Research Inc-Site Number:8400050
    South Jordan, Utah 84095, United States
  • Alliance for Multispecialty Research Syracuse-Site Number:8400066
    Syracuse, Utah 84075-9645, United States
  • Pediatric Medical Research of Charlottesville-Site Number:8400077
    Charlottesville, Virginia 22902, United States
  • Marshfield Clinic-Site Number:8400054
    Marshfield, Wisconsin 54449-5777, United States
  • Investigational Site Number :6300014
    San Juan, 00918, Puerto Rico
  • Investigational Site Number :6300108
    San Juan, 00918, Puerto Rico
09

References and documents

Study documents

  • Study protocol · May 29, 2019
  • Statistical analysis plan · Mar 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03673462
Lead sponsor
Sanofi Pasteur, a Sanofi Company
Responsible party
Sponsor
First posted
Sep 17, 2018
Start date
Sep 17, 2018
Primary completion
Mar 16, 2023
Completion
Mar 16, 2023
Results posted
Oct 5, 2023
Last update
Dec 14, 2023

Study contacts

Clinical Sciences & Operations
study director · Sanofi Pasteur, a Sanofi Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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