06 Schillie mening 508

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Work Group Considerations Regarding 
MenQuadfi in Infants
Sarah Schillie, MD, MPH, MBA
Advisory Committee on Immunization Practices
April 16, 2025National Center for Immunization & Respiratory Diseases
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The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f 
the U. S. Centers for Disease Control and Prevention.
Studies Reviewed
Three Phase III studies in U.S. infants aged 6 weeks – 19 
months
– 4,321 infants enrolled in MenACWY -TT arm
•2 studies:  3+1 schedule (ages 2, 4, 6, 12 or 12– 18 months)
•1 study:  1+1 schedule (age ≥6 months)
–Comparator vaccine:  1,717 infants received MenACWY -CRM or 
MenACWY -D
Vaccine co -administered with pediatric vaccines (6 arms)
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Seroresponse:  Met42
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Seroresponse:  Met61
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4 of 11
Solicited Local and Systemic Adverse Reactions:  Met42
Group 1= 
MenACWY -TT 
+ routine pediatric vaccines
Group 2 
=MenACWY -
CRM + routine pediatric vaccines
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Solicited Local Adverse Reactions:  Met61
Group 1= MenACWY -TT + 
routine pediatric vaccines 
at 6-7 months and 12 -13 
months
Group 2 =MenACWY -CRM 
+ routine pediatric 
vaccines at 6 -7 months 
and 12 -13 months
Group 3 =MenACWY -TT at 
17-19 months and 20 -23 
months
Group 4 =MenACWY -D at 
17-19 months and 20 -23 
months
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Solicited Systemic Adverse Reactions:  Met61
Group 1= MenACWY -TT + 
routine pediatric vaccines 
at 6-7 months and 12 -13 
months
Group 2 =MenACWY -CRM 
+ routine pediatric 
vaccines at 6 -7 months 
and 12 -13 months
Group 3 =MenACWY -TT at 
17-19 months and 20 -23 
months
Group 4 =MenACWY -D at 
17-19 months and 20 -23 
months
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SAEs, AESIs, and Unsolicited AEs
Met41:  Imbalance of febrile/non- febrile seizures
–19 subjects in intervention group (n=2080, 0.9%) vs. 1 in 
comparison group (n=697, 0.1%) with febrile or non -febrile 
seizures
–All deemed not related to study vaccine by primary investigator and sponsor
Met42:  1 febrile seizure who received study vaccine
–Prior history of seizures/deemed related to study vaccine 
SAE, serious adverse event; AESI, adverse event of special interest; AE, adverse event8 of 13
SAEs, AESIs, and Unsolicited AEs, cont.
4 total deaths, all in intervention group and all deemed 
unrelated to study vaccine by primary investigator and sponsor
–Met41:  
•Non -accidental injury of the head (30 days after vaccination)
•Sudden unexplained death in infancy (24 days after vaccination)
•Found by parent unresponsive in bed (4 days after vaccination)
–Met42:  
•Cardiac arrest (6 days after vaccination)  
–Met61:  
•No deaths
SAE, serious adverse event; AESI, adverse event of special interest; AE, adverse event9 of 13
Pooled Safety Analysis:  Met41 and Met42
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Summary
Post -dose 4 seroresponse  overall similar for MenQuadfi vs. comparator
–Higher GMTs for Serogroup C among MenQuadfi  recipients (vs. comparator)  
Safety
–Solicited local and systemic reactions generally similar between 
study groups
•Local reactions slightly greater for MenQuadfi  in Met61
–Among MenQuadfi recipients in Met41 and Met42, greater 
proportion of:
•Febrile/non -febrile seizures
•Serious Adverse Events
•Deaths 11 of 13
Summary, cont.
Results among healthy infants may not be representative of 
results for infants recommended for vaccine based on risk factors
–Similar studies typically limited to healthy infants 
High attrition rates 
–Attributed to out -of-window visits, missed blood draws, COVID -19 
pandemic
Benefits of another vaccine option may outweigh risks
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13Acknowledgements
Lucy McNamara
Avnika Amin
Alison Albert
Amy Rubis
LeAnne Fox
Noele Nelson
Susan Hariri
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