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Virus Therapy

mRNA COVID-19 Vaccine Safety With Childhood Vaccines

Q: Has the FDA authorized concurrent immunization arm to be used?

There is ample evidence to affirm Simultaneous vaccination arm's safety, so it achieved a rating of 3.

Q: What requirements must I fulfill to participate in this medical experiment?

Prospective participants must have a fever and be between 6 months to 4 years old in order to join this medical study. Currently, the trial is attempting to enroll 600 individuals.

Q: Is this research study open to individuals aged 30 or above?

This medical trial is seeking patients between the ages of 6 months and 4 years old. Additionally, 66 studies are available for those under 18 years old while 145 accommodate seniors over 65.

Q: How many distinct sites are currently conducting this research trial?

Across the country, 5 medical centres are currently enrolling patients. Examples include the Centers for Disease Control and Prevention (Atlanta), Duke University (Durham) and Columbia University (<a href="https://www.withpower.com/clinical-trials/new-york">New york</a>). Additionally, there are other sites available to join this study.

Q: Are there any available vacancies for participants in this trial?

Contrary to what is posted on clinicaltrials.gov, it appears that this trial has stopped recruiting participants for the time being; although first added in September 1st 2023 and modified a week later, there are no open invitations at present. At the moment, 203 other medical studies have opened their recruitment phases nationwide.

Phase 4

Recruiting

Led By Michael J Smith, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Parental/LAR intention of child receiving mRNA COVID-19 vaccine and at least one recommended non-live vaccine

Child 6 months through <5 years of age at time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 105 days post administration

Awards & highlights

Study Summary

This trial will study if it's safe to give children COVID-19 vaccine and other routine childhood vaccines on the same day or at separate times.

Who is the study for?

This trial is for children aged 6 months to under 5 years who are due for their mRNA COVID-19 vaccine and at least one other non-live routine vaccine. Parents must be willing to delay the COVID-19 shot up to 3 weeks, consent to medical information release, and ensure follow-up. Children with active COVID-19, history of MIS-C, recent or planned experimental treatments, immunosuppression, certain severe allergies or reactions to vaccines are excluded.Check my eligibility

What is being tested?

The study tests the safety of giving young children the mRNA COVID-19 vaccine simultaneously with other childhood vaccines compared to spacing them out over separate visits. It's a prospective (looking forward in time), randomized (participants randomly assigned), open-label (no placebo control) trial.See study design

What are the potential side effects?

Potential side effects may include fever, seizures related to high body temperature (febrile seizures), and typical responses seen after vaccinations such as soreness at injection site or mild illness symptoms. The study specifically looks at whether these side effects increase when vaccines are given together.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I intend for my child to receive the mRNA COVID-19 vaccine and another recommended vaccine.

Select...

My child is between 6 months and 5 years old.

Select...

My child is scheduled to receive the mRNA COVID-19 vaccine and another recommended vaccine.

Select...

I, or my legal representative, can read English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 105 days post administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 105 days post administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 105 days post administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Fever Following Vaccination

Secondary outcome measures

Number of Participants who Received Antipyretics - Visit 1

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

Number of Participants who Received Antipyretics - Visit 2

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Simultaneous vaccination armExperimental Treatment2 Interventions

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.

Group II: Sequential vaccination armExperimental Treatment2 Interventions

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,419,916 Total Patients Enrolled

6 Trials studying Fever

46,150 Patients Enrolled for Fever

Kaiser PermanenteOTHER

538 Previous Clinical Trials

24,112,493 Total Patients Enrolled

2 Trials studying Fever

595 Patients Enrolled for Fever

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,446,659 Total Patients Enrolled

5 Trials studying Fever

1,487 Patients Enrolled for Fever

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA authorized concurrent immunization arm to be used?

"There is ample evidence to affirm Simultaneous vaccination arm's safety, so it achieved a rating of 3."

Answered by AI

What requirements must I fulfill to participate in this medical experiment?

"Prospective participants must have a fever and be between 6 months to 4 years old in order to join this medical study. Currently, the trial is attempting to enroll 600 individuals."

Answered by AI

Is this research study open to individuals aged 30 or above?

"This medical trial is seeking patients between the ages of 6 months and 4 years old. Additionally, 66 studies are available for those under 18 years old while 145 accommodate seniors over 65."

Answered by AI

How many distinct sites are currently conducting this research trial?

"Across the country, 5 medical centres are currently enrolling patients. Examples include the Centers for Disease Control and Prevention (Atlanta), Duke University (Durham) and Columbia University (New york). Additionally, there are other sites available to join this study."

Answered by AI

Are there any available vacancies for participants in this trial?

"Contrary to what is posted on clinicaltrials.gov, it appears that this trial has stopped recruiting participants for the time being; although first added in September 1st 2023 and modified a week later, there are no open invitations at present. At the moment, 203 other medical studies have opened their recruitment phases nationwide."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children

2023. "Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06038617.

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