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

Phase 3

Completed

Conditions: Healthy Volunteers (Meningococcal Infection)

Interventions: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)
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

Registration Number: NCT03673462

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2797

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: MenACYW Conjugate Vaccine	Measles, Mumps, and Rubella Virus 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.
Group 1: MenACYW Conjugate Vaccine	Varicella Virus 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.
Group 2: MENVEO®	Pneumococcal 13-valent Conjugate Vaccine	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.
Group 2: MENVEO®	Rotavirus Vaccine	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.
Group 1: MenACYW Conjugate Vaccine	Rotavirus 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.
Group 1: MenACYW Conjugate Vaccine	Pneumococcal 13-valent 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.
Group 1: MenACYW Conjugate Vaccine	Hepatitis B 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.
Group 1: MenACYW Conjugate Vaccine	Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (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.
Group 2: MENVEO®	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (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.
Group 2: MENVEO®	Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine	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.
Group 2: MENVEO®	Measles, Mumps, and Rubella Virus Vaccine	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.
Group 1: MenACYW Conjugate Vaccine	Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b 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.
Group 2: MENVEO®	Hepatitis B Vaccine	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.
Group 2: MENVEO®	Varicella Virus Vaccine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)	Within 30 minutes post-any vaccination	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.
Number of Participants With Solicited Injection Site Reactions	Within 7 days post any vaccination	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.
Number of Participants With Solicited Systemic Reactions	Within 7 days post-any vaccination	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.
Number of Participants With Medically Attended Adverse Event (MAAEs)	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)	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.
Number of Participants With Unsolicited Adverse Events	Within 30 days post any vaccination	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.
Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)	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)	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (69): Senders Pediatrics-Site Number:8400061
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South Euclid, Ohio, United States
Southeastern Pediatric Associates-Site Number:8400034
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Dothan, Alabama, United States
De Armas Research Center,-Site Number:8400088
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Miami, Florida, United States
Healthy Life Research-Site Number:8400075
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Miami, Florida, United States
Acevedo Clinical Research Associates-Site Number:8400032
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Miami, Florida, United States
Birmingham Pediatric Associates-Site Number:8400049
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Birmingham, Alabama, United States
MedPharmics, LLC - Phoenix-Site Number:8400043
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Phoenix, Arizona, United States
Southwest Children's Research Associates, P.A.-Site Number:8400002
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San Antonio, Texas, United States
J. Lewis Research-Site Number:8400053
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Salt Lake City, Utah, United States
Foothill Family Research-South-Site Number:8400036
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Salt Lake City, Utah, United States
Avail Clinical Research, LLC-Site Number:8400055
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DeLand, Florida, United States
Northwest Arkansas Pediatric Clinic-Site Number:8400042
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Fayetteville, Arkansas, United States
HealthStar Research, LLC-Site Number:8400100
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Hot Springs, Arkansas, United States
Emmaus Research Center, Inc-Site Number:8400057
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Anaheim, California, United States
The Children's Clinic of Jonesboro, PA-Site Number:8400059
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Jonesboro, Arkansas, United States
Premier Health Research Center, LLC-Site Number:8400039
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Downey, California, United States
Center for Clinical Trials of San Gabriel-Site Number:8400051
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West Covina, California, United States
Advanced Clinical Research - Rancho Paseo-Site Number:8400087
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Banning, California, United States
Center for Clinical Trials, LLC-Site Number:8400056
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Paramount, California, United States
Center for Clinical Trials of San Gabriel-Site Number:8400099
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West Covina, California, United States
IMMUNOe Research Centers - Thornton-Site Number:8400022
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Thornton, Colorado, United States
Optum Clinical Research-Site Number:8400076
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Colorado Springs, Colorado, United States
Advanced Research for Health Improvement-Site Number:8400096
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Fort Myers, Florida, United States
Sarkis Clinical Trials-Site Number:8400003
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Gainesville, Florida, United States
Crystal Biomedical Research-Site Number:8400018
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Miami Lakes, Florida, United States
Advanced Research for Health Improvement-Site Number:8400005
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Naples, Florida, United States
MOC Research-Site Number:8400095
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Mishawaka, Indiana, United States
Meridian Clinical Research-Site Number:8400114
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Macon, Georgia, United States
Kentucky Pediatics / Adult Research-Site Number:8400044
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Bardstown, Kentucky, United States
University of Louisville-Site Number:8400082
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Louisville, Kentucky, United States
Brownsboro Park Pediatrics-Site Number:8400040
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Louisville, Kentucky, United States
Pediatric Associates of Fall River-Site Number:8400103
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Fall River, Massachusetts, United States
All Children Pediatrics-Site Number:8400069
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Louisville, Kentucky, United States
MedPharmics-Site Number:8400048
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Metairie, Louisiana, United States
Center for Pharmaceutical Research-Site Number:8400080
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Kansas City, Missouri, United States
Midwest Childrens Health Research Institute-Site Number:8400060
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Lincoln, Nebraska, United States
Craig Spiegel, MD-Site Number:8400067
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Bridgeton, Missouri, United States
MedPharmics Biloxi-Site Number:8400052
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Biloxi, Mississippi, United States
Ford, Simpson, Lively & Rice Pediatrics-Site Number:8400021
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Winston-Salem, North Carolina, United States
Legacy Pediatrics-Site Number:8400004
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Rochester, New York, United States
Ohio Pediatric Research-Site Number:8400064
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Dayton, Ohio, United States
PriMed Clinical Research-Site Number:8400033
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Dayton, Ohio, United States
Cyn3rgy Research-Site Number:8400035
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Gresham, Oregon, United States
The Children's Center Rehabilitation Hospital-Site Number:8400104
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Bethany, Oklahoma, United States
Rainbow Pediatrics-Site Number:8400074
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Barnwell, South Carolina, United States
PMG Research-Bristol-Site Number:8400009
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Bristol, Tennessee, United States
Palmetto Pediatrics, PA-Site Number:8400089
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North Charleston, South Carolina, United States
PMG Research of Charleston, LLC-Site Number:8400102
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Mount Pleasant, South Carolina, United States
Holston Medical Group, Pediatrics at Stone Plaza-Site Number:8400015
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Kingsport, Tennessee, United States
Pediatric Clinical Trials Tullahoma-Site Number:8400062
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Tullahoma, Tennessee, United States
ARC Clinical Research at Wilson Parke-Site Number:8400071
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Austin, Texas, United States
Benchmark Research - Buda-Site Number:8400016
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Buda, Texas, United States
Benchmark Research - San Angelo-Site Number:8400011
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San Angelo, Texas, United States
Crossroads Clinical Research-Site Number:8400058
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Corpus Christi, Texas, United States
Murray Pediatrics-Site Number:8400019
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Murray, Utah, United States
Tanner Clinic-Site Number:8400079
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Clinton, Utah, United States
Wee Care Pediatrics-Site Number:8400065
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Kaysville, Utah, United States
Utah Valley Pediatrics - Timpanogos-Site Number:8400038
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Orem, Utah, United States
Pediatric Care-Site Number:8400045
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Provo, Utah, United States
J Lewis Research Inc-Site Number:8400050
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South Jordan, Utah, United States
Copperview Medical Center-Site Number:8400068
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South Jordan, Utah, United States
Pediatric Medical Research of Charlottesville-Site Number:8400077
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Charlottesville, Virginia, United States
Alliance for Multispecialty Research Syracuse-Site Number:8400066
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Syracuse, Utah, United States
Investigational Site Number :6300014
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San Juan, Puerto Rico
Marshfield Clinic-Site Number:8400054
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Marshfield, Wisconsin, United States
Investigational Site Number :6300108
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San Juan, Puerto Rico
Oklahoma State University - Center for Health Sciences-Site Number:8400008
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Tulsa, Oklahoma, United States
Medication Management-Site Number:8400072
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Greensboro, North Carolina, United States
Coastal Pediatric Research Charleston-Site Number:8400037
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Charleston, South Carolina, United States