Safety of Simultaneous mRNA COVID-19 Vaccine With Other C... | NCT06038617

Status Module

Name	Class
Kaiser Permanente	OTHER
Columbia University	OTHER
Children's Hospital Medical Center, Cincinnati	OTHER
Centers for Disease Control and Prevention

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Simultaneous vaccination arm	Experimental	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2.	Biological: mRNA COVID-19 Vaccine Biological: Routine Childhood Vaccinations
Sequential vaccination arm	Experimental	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2.	Biological: mRNA COVID-19 Vaccine Biological: Routine Childhood Vaccinations

Name	Type	Description	Arm Group Labels	Other Names
mRNA COVID-19 Vaccine	Biological	ACIP Recommended Vaccine	Sequential vaccination arm Simultaneous vaccination arm

Measure	Description	Time Frame
Number of Participants With Fever Following Vaccination	Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.	2 Days Post-Administration

Measure	Description	Time Frame
Number of Participants With Fever Following Visit 1	Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1	2 Days Post Visit 1
Number of Participants With Fever Following Visit 2

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Child 6 months through <5 years of age at time of enrollment.
Child is due to receive mRNA COVID-19 vaccine and at least one other routinely recommended non-live vaccine per CDC or ACIP recommendations.
Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one recommended non-live vaccine.
The parent/LAR must be willing and capable of providing permission for their child to participate through the written informed consent process.
The parent/LAR must be available for follow-up and must at minimum have telephone access.
The parent/LAR must agree to sign a medical release for the child so that study personnel may obtain medical information about the child's health (if needed).
The parent/LAR must be willing to delay COVID-19 vaccination for their child for up to 3 weeks.
The parent/LAR must be able to read English or Spanish.

Exclusion Criteria:

History of any seizure (including febrile seizure) or first degree relative (biologic parent or biologic sibling including half-sibling) with a history of febrile seizure.
Contraindication to mRNA COVID-19 vaccine: A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of the COVID-19 vaccine or a known diagnosed allergy to a component of COVID-19 vaccine.
A history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component of a vaccine administered on the day of study enrollment.
For children receiving DTaP vaccine (alone or combination vaccine): Encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures), not attributable to another identifiable cause, within 7 days of administration of previous dose of DTP or DTaP.
Received any other non-live vaccines within 14 days prior to enrollment or any other live vaccines within 28 days prior to enrollment.
Intention to receive non-COVID-19 non-live or live vaccines during the 4 weeks after Visit 1; vaccines may be administered after enrollment if deemed a personal or public health priority by the health care provider caring for this patient or the study team.
Received prior COVID-19 vaccine as part of a clinical trial.
Received any experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to enrollment in this study or expects to receive an experimental/investigational agent during the study.
A moderate to severe acute illness and/or a reported temperature ≥ 100.4°F (≥38.0°C) within 48 hours prior to enrollment or a temperature (measured by temporal artery thermometer) ≥100.4°F (≥38.0°C) at the time of enrollment. (This may result in a temporary delay of vaccination).
Receipt of an antipyretic medication (acetaminophen or ibuprofen) within 72 hours prior to enrollment (this may result in a temporary delay of vaccination) or planned receipt of a prophylactic antipyretic medication on the day of and/or days following vaccination prior to any measured increase in temperature in anticipation of a fever (this exclusion does not apply if the Parent/LAR indicates they might administer antipyretics or analgesics after vaccination to reduce a fever or pain).
Immunosuppression as a result of an underlying illness or treatment, or use of anti-cancer chemotherapy or radiation therapy since birth.
Long term (at least 14 days of prednisone 2 mg/kg/day or equivalent other glucocorticoid) use of any parenteral steroids or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the 6 months prior to enrollment (topical and nasal steroids are allowed).
Has an active case of COVID-19 infection.
History of multisystem inflammatory syndrome (MIS-C).
History of myocarditis or pericarditis.
Has any condition that would, in the opinion of the site investigator, place the participant at an unacceptable risk of injury or render the participant unable to meet the requirements of the protocol.
Any child or grandchild of a study investigator or study team member.

Name	Affiliation	Role
Michael J Smith, MD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente Northern California		Oakland	California	94612	United States
Centers for Disease Control and Prevention

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 18, 2025

Arm/Group Information

ID	Title	Description
BG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
BG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000174 BG001168 BG002342

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Fever Following Vaccination

Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1 and/or Visit 2.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post-Administration

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants	OG000169 OG001166

Title

Denominators

Categories

Title	Measurements
	OG00014 OG00110

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The null hypothesis is that the simultaneous group is inferior (i.e., simultaneous group will have a higher rate) to the sequential group regarding the proportion of children with fever on Day 1 or Day 2.					Difference in proportions	0.0039			2-Sided	90	-3.46	7.97			The upper bound of a stratified Newcombe binomial confidence interval with Cochran-Mantel-Haenszel weighting of the difference was used.		Non-Inferiority	The one-sided non-inferiority test with the alpha level set at 0.025 and non-inferiority margin of 10%, stratified by site.

Secondary

Number of Participants With Fever Following Visit 1

Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 1

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants

Secondary

Number of Participants With Fever Following Visit 2

Number of children with fever (temperature ≥ 38.0°C or ≥ 100.4°F) on day 1 and/or day 2 following Visit 2

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants

Secondary

Number of Participants With Grade 2 and/or 3 Fever Following Visit 1 and Visit 2 Combined

Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1 and Visit 2 combined. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Administration

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units

Secondary

Number of Participants With Grade 2 and/or 3 Fever Following Visit 1

Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 1. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts

Secondary

Number of Participants With Grade 2 and/or 3 Fever Following Visit 2

Number of children with moderate/severe fever (Grade 2 and/or 3) on day 1 and/or day 2 following Visit 2. (Moderate/severe fever: ≥ 38.4°C or ≥ 101.2°F)

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts

Secondary

Number of Participants With Medical Care Utilization for Fever - Visit 1 and Visit 2 Combined

Number of children with medical care utilization (medical advice (telephone, patient portal), urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and /or day 2 following Visit 1 and Visit 2 combined.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Administration

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Secondary

Number of Participants With Medical Care Utilization for Fever - Visit 1

Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 1.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Secondary

Number of Participants With Medical Care Utilization for Fever- Visit 2

Number of children with medical care utilization (medical advice (telephone, patient portal),urgent care visit, emergency department visit, and hospital admission) for fever on day 1 and/or day 2 following Visit 2.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Secondary

Number of Participants Who Received Antipyretics - Visit 1 and Visit 2 Combined

Number of children who received antipyretics on day 1 and/or day 2 following Visit 1 and Visit 2 combined.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Administration

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts

Secondary

Number of Participants Who Received Antipyretics - Visit 1

Number of children who received antipyretics on day 1 and/or day 2 following Visit 1.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants

Secondary

Number of Participants Who Received Antipyretics - Visit 2

Number of children who received antipyretics on day 1 and/or day 2 following Visit 2.

Modified Intent-to-Treat (mITT) Population: Any participant with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

2 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants

Secondary

Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 6-23 Months Old

Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

Modified Intent-to-Treat (mITT) Population: Any participant age 6-23 months with data collected who was enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

Up to 7 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Secondary

Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 6-23 Months Old

Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

Modified Intent-to-Treat (mITT) Population: Any participant age 6-23 months enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

Up to 7 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units

Secondary

Number of Participants With Defined Systemic Reactogenicity Events at Visit 1, Ages 2-5 Years Old

Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

Modified Intent-to-Treat (mITT) Population: Any participant age 2-5 years old enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

Up to 7 Days Post Visit 1

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units

Secondary

Number of Participants With Defined Systemic Reactogenicity Events at Visit 2, Ages 2-5 Years Old

Tables summarizing each solicited local and systemic reactogenicity event by maximum classification (none, mild, moderate, and severe), as well as by moderate or severe

Modified Intent-to-Treat (mITT) Population: Any participant age 2-5 years old enrolled and randomized into the study, and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

Up to 7 Days Post Visit 2

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units

Secondary

The Number of Individuals With At Least One Serious Adverse Event

Modified Intent-to-Treat (mITT) Population: Any participant enrolled and randomized into the study and received at least one study vaccine at Visit 1.

Posted

Count of Participants

Participants

Up to 105 Days Post Administration

ID	Title	Description
OG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines
OG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Simultaneous Vaccination Arm	The simultaneous vaccination group will receive routine childhood vaccinations and mRNA COVID-19 vaccination at Visit 1, followed by a health education visit without vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines	0	174	2	174	0	174
EG001	Sequential Vaccination Arm	The sequential vaccination group will receive routine childhood vaccinations at Visit 1, followed by a health education visit with mRNA COVID-19 vaccination at Visit 2. mRNA COVID-19 Vaccine: ACIP Recommended Vaccine Routine Childhood Vaccinations: ACIP Recommended Vaccines	0	168	1	168	9	168

Term	Organ System	Assessment Type	Statistical Information
Croup	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 events0 affected174 at risk EG0011 events1 affected168 at risk
Anaphylaxis	Immune system disorders	Non-systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected168 at risk
Viral Infection	General disorders	Non-systematic Assessment	EG0001 events1 affected174 at risk EG0010 events0 affected168 at risk

ID	Term
D005334	Fever
D003294	Seizures, Febrile

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
C000722934	CVnCoV COVID-19 vaccine
D000090982	BNT162 Vaccine
D000090983	2019-nCoV Vaccine mRNA-1273
C050102	measles, mumps, rubella, varicella vaccine
D022362	Hepatitis A Vaccines
D017325	Hepatitis B Vaccines
D007252	Influenza Vaccines

ID	Term
D000087503	mRNA Vaccines
D000087504	Nucleic Acid-Based Vaccines
D014614	Vaccines, Synthetic
D011994	Recombinant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures
D000086663	COVID-19 Vaccines
D014765	Viral Vaccines
D000941	Antigens
D001685	Biological Factors
D014761	Viral Hepatitis Vaccines