mRNA COVID-19 Vaccine Safety With Childhood Vaccines

Recruiting at 4 trial locations

Overseen By Emily A Randolph, MBA

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Duke University

Must be taking: mRNA COVID-19 vaccine

Must not be taking: Antipyretics, Steroids

Disqualifiers: Seizures, Allergies, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19 vaccine and other vaccines at separate visits (Visits 1 and 2).

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications. However, if your child is on long-term steroids or has received certain vaccines recently, they may not be eligible to participate.

What data supports the effectiveness of the drug Pfizer-BioNTech COVID-19 Vaccine in combination with routine childhood vaccinations?

The Pfizer-BioNTech COVID-19 vaccine has shown high efficacy (over 90%) in preventing COVID-19 in children aged 5-11 years, and the benefits of vaccination are considered to outweigh the risks. This suggests that the vaccine is effective in protecting children against COVID-19 and can help reduce the spread of the virus in the community. ^{1 2 3 4 5}

Is the mRNA COVID-19 vaccine safe for children when given with routine childhood vaccines?

The mRNA COVID-19 vaccine (Pfizer-BioNTech) has been generally well tolerated in children, with no severe adverse events reported in studies. Some cases of myocarditis (heart inflammation) have been noted, but overall, the vaccine's safety profile is considered good, with most side effects being mild and temporary. ^{1 2 4 5 6}

How does the Pfizer-BioNTech COVID-19 vaccine differ from other COVID-19 vaccines for children?

The Pfizer-BioNTech COVID-19 vaccine, also known as Comirnaty, is unique because it is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine specifically designed to encode the spike protein of the virus that causes COVID-19. It has been authorized for use in children as young as 5 years old, with a specific dosage and schedule tailored for this age group, making it distinct from other COVID-19 vaccines. ^{1 2 4 5 7}

Research Team

Michael J Smith, MD

Principal Investigator

Duke University

Eligibility Criteria

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.

Inclusion Criteria

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)

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

Exclusion Criteria

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

You had a serious allergic reaction in the past to a vaccine or any of its ingredients.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Vaccination

Participants receive either simultaneous or sequential vaccinations, including mRNA COVID-19 and routine childhood vaccines

1 day

Visit 1 and Visit 2

Monitoring

Participants are monitored for fever and other adverse events for 7 days following each vaccination visit

7 days

Follow-up

Participants are monitored for serious adverse events and parental perceptions are assessed

Up to 105 days

Treatment Details

Interventions

• Pfizer-BioNTech COVID-19 Vaccine
• Routine Childhood Vaccinations

Trial Overview 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.

Participant Groups

Group I: Simultaneous vaccination arm Experimental Treatment 2 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 arm Experimental Treatment 2 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.

Pfizer-BioNTech COVID-19 Vaccine is already approved in European Union, United States, Canada, United Kingdom for the following indications:

Approved in European Union as Comirnaty for:

• Prevention of COVID-19 disease in individuals 12 years of age and older

Approved in United States as Comirnaty for:

• Prevention of COVID-19 disease in individuals 6 months of age and older

Approved in Canada as Comirnaty for:

• Prevention of COVID-19 disease in individuals 6 months of age and older

Approved in United Kingdom as Comirnaty for:

• Prevention of COVID-19 disease in individuals 12 years of age and older

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Findings from Research

In a study of 2030 healthcare workers, those previously infected with COVID-19 reported a higher incidence of side effects after the first dose of the Comirnaty vaccine compared to those who had not been infected, with 46.76% experiencing side effects versus 29.15%.

After the second dose, the side effect rate for previously infected individuals was lower (63.23%) compared to those not previously infected (70.79%), suggesting that prior infection may influence the vaccine's side effect profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. Ossato, A., Tessari, R., Trabucchi, C., et al.[2023]

The Pfizer-BioNTech COVID-19 vaccine (Comirnaty) has been approved for individuals aged 16 and older and is also authorized for emergency use in children aged 5-11, with over 248 million doses administered in the U.S. by November 2021.

The vaccine demonstrates high efficacy of over 90% in preventing COVID-19 in children aged 5-11, and the Advisory Committee on Immunization Practices (ACIP) concluded that the benefits of vaccination outweigh the risks, emphasizing its importance in protecting children and reducing virus transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021. Woodworth, KR., Moulia, D., Collins, JP., et al.[2021]

A survey of 197 parents in central Italy revealed that 84.3% of children aged 5-11 experienced at least one adverse event after receiving the mRNA BNT162b2 vaccine, with most events being mild to moderate in severity.

The most common adverse reactions were local symptoms at the injection site, with no serious adverse events reported, indicating a favorable safety profile for the vaccine in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy. Ripabelli, G., Sammarco, ML., D'Amico, A., et al.[2023]

The active pharmacovigilance study conducted in central Italy assessed the safety of the mRNA BNT162b2 COVID-19 vaccine in children aged 5-11 years, providing important data on its safety profile.

The correspondence highlights the ongoing discussion and scrutiny regarding the vaccine's safety in this age group, emphasizing the need for transparent communication of findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Author's reply to correspondence. Ripabelli, G., Salzo, A., Tamburro, M.[2023]

In a case series of 15 children hospitalized with myocarditis after receiving the Pfizer-BioNTech COVID-19 vaccine, symptoms typically appeared 1 to 6 days post-vaccination, with chest pain being the most common symptom.

Despite the diagnosis of myocarditis, the patients were mildly affected overall, with most showing resolution of symptoms shortly after hospitalization, indicating that while myocarditis can occur, it appears to be manageable in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children. Dionne, A., Sperotto, F., Chamberlain, S., et al.[2022]

A study involving 21 children with a history of pediatric inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) and 71 healthy controls found that the Pfizer-BioNTech COVID-19 mRNA vaccine (Comirnaty®) was safe, with no severe adverse events reported in either group.

The frequency of adverse events was similar between the PIMS group and controls, although local hardening at the injection site was more common in the PIMS group. Importantly, the vaccine did not trigger any PIMS-like symptoms in any of the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID-19 mRNA BNT162b2 vaccine safety and B-cell and T-cell reactogenicity among children with a history of paediatric multisystem inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) - preliminary study. Ludwikowska, KM., Popiel, A., Matkowska-Kocjan, A., et al.[2023]

A study analyzing 4838 reports from the European database EudraVigilance found that mRNA COVID-19 vaccines, particularly BNT162b2, have a favorable safety profile in children aged 5-11, with serious adverse events reported in 38.7% of cases, but most were manageable.

The most common side effects included fever, headache, and vomiting, with only 20 cases of Multisystem Inflammatory Syndrome reported, indicating that while monitoring is essential, the benefits of vaccination in this age group outweigh the risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study. Zinzi, A., Gaio, M., Liguori, V., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparison of medium-term adverse reactions induced by the first and second dose of mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine: a post-marketing Italian study conducted between 1 January and 28 February 2021. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine in Children Aged 5-11 Years - United States, November 2021. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Author's reply to correspondence. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Association of Myocarditis With BNT162b2 Messenger RNA COVID-19 Vaccine in a Case Series of Children. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

COVID-19 mRNA BNT162b2 vaccine safety and B-cell and T-cell reactogenicity among children with a history of paediatric multisystem inflammatory syndrome temporally associated with COVID-19 (PIMS-TS) - preliminary study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Monitoring of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years by Using EudraVigilance Pharmacovigilance Database: The CoVaxChild Study. [2023]