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.
Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
2,797
Pharmaceutical form: Liquid solution. Route of administration: Intramuscular
Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular
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
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
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
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.
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Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Oral solution Route of administration: Oral
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous
Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
Birmingham Pediatric Associates-Site Number:8400049
Birmingham, Alabama, United States
Southeastern Pediatric Associates-Site Number:8400034
Dothan, Alabama, United States
MedPharmics, LLC - Phoenix-Site Number:8400043
Phoenix, Arizona, United States
Northwest Arkansas Pediatric Clinic-Site Number:8400042
Fayetteville, Arkansas, United States
HealthStar Research, LLC-Site Number:8400100
Hot Springs, Arkansas, United States
The Children's Clinic of Jonesboro, PA-Site Number:8400059
Jonesboro, Arkansas, United States
Emmaus Research Center, Inc-Site Number:8400057
Anaheim, California, United States
Advanced Clinical Research - Rancho Paseo-Site Number:8400087
Banning, California, United States
Premier Health Research Center, LLC-Site Number:8400039
Downey, California, United States
Center for Clinical Trials, LLC-Site Number:8400056
Paramount, California, United States
...and 59 more locations
Time frame: Within 30 days post any vaccination
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)
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)