COVID-19 Vaccine for Children

Recruiting at 135 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: BioNTech SE

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: MIS-C, Autoimmune disease, Myocarditis, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

4292 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new COVID-19 vaccine for children. Researchers aim to determine how well the vaccine works across different age groups and identify any side effects. The trial includes healthy children who have either never been vaccinated for COVID-19 or have only received the BNT162b2 vaccine (also known as the Bivalent BNT162b2 Omicron-containing vaccine). Healthy children meeting these criteria might be suitable candidates for this study. As a Phase 2, Phase 3 trial, this study is crucial for assessing the vaccine's effectiveness in a larger group and represents the final step before FDA approval, offering a chance to contribute to important vaccine development.

Do I need to stop my current medications to join the trial?

You may need to stop certain medications, especially if they are immunosuppressants or systemic corticosteroids, as these are not allowed within 60 days before joining the trial and during the study. If you are on these medications, you should discuss with the trial team to see if you need to stop them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Bivalent BNT162b2 Omicron vaccine has been tested in various age groups, including children, and has been approved for use in different populations with a good safety record. Studies with children have found no serious safety issues.

For instance, in one study involving 1,005 children who received the vaccine, none contracted COVID-19, while 16 children who received a placebo did. This result indicates that the vaccine effectively protects against COVID-19. It is also approved for older children and adults, suggesting it is generally well-tolerated.

While all vaccines can cause side effects, they are usually mild. Common side effects might include a sore arm or feeling tired for a day or two. Ongoing research continues to monitor for any new safety information. So far, the data suggests that the vaccine is safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Bivalent BNT162b2 Omicron-containing vaccine for children because it specifically targets newer variants of the COVID-19 virus. Unlike older vaccines that were primarily based on the original strain, this updated version includes components that address mutations found in the Omicron variant, potentially enhancing its effectiveness. The vaccine is also being tested in various dosages and schedules, allowing for tailored approaches depending on the child's age group, which could lead to optimized immunity with fewer doses. This flexibility in dosing could make the vaccination process more efficient and adaptable to different needs.

What evidence suggests that this trial's treatments could be effective for COVID-19 in children?

Research has shown that the bivalent BNT162b2 Omicron-containing vaccine, studied in this trial, works well in children. One study found it to be 58.3% effective for kids aged 5 to 11 years. It also helps prevent severe COVID-19, reducing the risk of serious illness or hospitalization by up to 69%. The vaccine boosts the immune system by increasing antibodies that fight the virus. Earlier research indicated it offers quick protection against the Omicron variant. This suggests the vaccine could help protect children from COVID-19 and its variants. Participants in this trial will receive different dosages and schedules of this vaccine to evaluate its effectiveness and safety across various age groups. ^{4 6 7 8 9}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Healthy children aged 6 months to less than 12 years are eligible for this trial. They must not have had any previous COVID-19 vaccinations, a history of severe vaccine reactions, or conditions like MIS-C, autoimmune diseases, myocarditis/pericarditis. Pregnant/breastfeeding females and those on immunosuppressants are excluded.

Inclusion Criteria

I am a healthy child aged 2 to 11 years.

I am a healthy child between 6 months and 5 years old.

I am a healthy child aged 6 months to under 5 years.

Exclusion Criteria

I am currently pregnant or breastfeeding.

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s)

I have had myocarditis or pericarditis in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study vaccine (variant-adapted BNT162b2 RNA-based vaccine) in various dosing schedules depending on the substudy and group

11 weeks

Multiple visits for each dose administration

Follow-up

Participants are monitored for safety, side effects, and immune response after the last dose

6 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Bivalent BNT162b2 Omicron containing vaccine

Trial Overview The study is testing variant-adapted BNT162b2 RNA vaccines targeting Omicron variants in healthy children. It's divided into substudies based on age and prior vaccination status with different doses administered as shots depending on the group.

How Is the Trial Designed?

Group I: 6 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group II: 6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Experimental Treatment 2 Interventions

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Group III: 6 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group IV: 6 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Experimental Treatment 3 Interventions

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Group V: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group VI: 3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group VII: 3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1) Experimental Treatment 1 Intervention

Injection in the muscle, 2 doses 2 months apart

Group VIII: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 3) - 0/3/11 week schedule Experimental Treatment 1 Intervention

Injection in the muscle at 0-, 3-, and 11-weeks

Group IX: 3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Experimental Treatment 2 Interventions

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Group X: 3 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Experimental Treatment 2 Interventions

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Group XI: 10 microgram dose, 6 months to <2 years (Substudy A Phase 2/3, Group 6) - 0/8 week schedule Experimental Treatment 1 Intervention

Injection in the muscle at 0- and 8-weeks

Group XII: 10 microgram dose, 6 Months to <2 Years (Substudy C, Phase 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XIII: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 2) - 0/8 week schedule Experimental Treatment 1 Intervention

Injection in the muscle at 0- and 8-weeks

Group XIV: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 2/3, Group 1) - 0/8 week schedule Experimental Treatment 1 Intervention

Injection in the muscle at 0- and 8-weeks

Group XV: 10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1) Experimental Treatment 2 Interventions

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Group XVI: 10 microgram dose, 5 to <12 Years (Substudy D, Group 3) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XVII: 10 microgram dose, 5 to <12 Years (Substudy D, Group 2) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XVIII: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XIX: 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XX: 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 5) - Single dose Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XXI: 10 microgram dose, 2 to <5 Years (Substudy A, Phase 2/3, Group 4) - Single dose Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XXII: 10 microgram dose, 2 Years to <5 Years (Substudy C, Phase 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

Group XXIII: 10 microgram dose, 2 Years to <4 years 3 months (Substudy A, Phase 1) Experimental Treatment 1 Intervention

Injection in the muscle at 0-, 3-, and 11-weeks and approximately 6-months post-Dose 3

Bivalent BNT162b2 Omicron containing 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 caused by SARS-CoV-2 virus

Approved in United States as Comirnaty for:

• Prevention of COVID-19 caused by SARS-CoV-2 virus

Approved in Canada as Comirnaty for:

• Prevention of COVID-19 caused by SARS-CoV-2 virus

Approved in United Kingdom as Comirnaty for:

• Prevention of COVID-19 caused by SARS-CoV-2 virus

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

Prof. Dr. Ugur Sahin

BioNTech SE

Chief Executive Officer since 2008

MD from University of Cologne

Prof. Özlem Türeci

BioNTech SE

Chief Medical Officer since 2018

MD from Saarland University

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study of 43 children and adolescents with cancer and hematologic diseases, those currently undergoing treatment (on-therapy) showed significantly lower immune responses to the BNT162b2 mRNA COVID-19 vaccine compared to those who were not on treatment (off-therapy), with only 33.3% achieving seroprotective levels against the Delta variant.

The findings suggest that many patients on immunosuppressive therapy may require an additional vaccine dose to improve their immune response, as 14 children in the on-therapy group needed this extra dose for better protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Response after 2 Doses of BNT162b2 mRNA COVID-19 Vaccinations in Children and Adolescents with Cancer and Hematologic Diseases. Poparn, H., Srichumpuang, C., Sosothikul, D., et al.[2022]

In a study of 48,826 children aged 5-11 in Quebec, Canada, the effectiveness of the BNT162b2 vaccine against symptomatic COVID-19 infection decreased significantly over time, from 68% to 25% between 14-55 days and 56-385 days post-vaccination.

The vaccine's effectiveness also varied by Omicron subvariant, dropping from 70% during BA.1 to 32% during BA.2, and becoming nonprotective during the BA.4/5 dominance, indicating that the vaccine's efficacy is influenced by both time since vaccination and the specific variant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of BNT162b2 Vaccine Against Omicron-SARS-CoV-2 Subvariants in Children 5-11 Years of Age in Quebec, Canada, January 2022 to January 2023. Razafimandimby, H., Sauvageau, C., Ouakki, M., et al.[2023]

In a study of over 1.1 million participants, children aged 5-10 who received the second dose of the BNT162b2 vaccine had a 2.3 times lower rate of confirmed SARS-CoV-2 infection compared to those who had just received the first dose, indicating strong efficacy against the omicron variant.

Adolescents aged 12-15 who received a booster dose showed a 3.3 times reduction in confirmed infection rates compared to those who received the booster recently, further demonstrating the effectiveness of the BNT162b2 vaccine in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial protection against SARS-CoV-2 omicron lineage infection in children and adolescents by BNT162b2 in Israel: an observational study. Amir, O., Goldberg, Y., Mandel, M., et al.[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]

The BNT162b2 vaccine showed high effectiveness against COVID-19 in children and adolescents, with initial vaccine effectiveness (VE) of 93% during the Delta variant period, which decreased over time, particularly after 150 days.

During the Omicron period, VE was significantly lower, dropping to 64% for ages 12-15 and 31% for ages 16-17, but a monovalent booster increased VE to 54% and 46% respectively, highlighting the importance of booster doses for maintaining protection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents. Klein, NP., Demarco, M., Fleming-Dutra, KE., et al.[2023]

In a study involving over 120,000 tests from children and adolescents, the effectiveness of two doses of the BNT162b2 COVID-19 vaccine against symptomatic infection was found to be 60.1% for children and 59.5% for adolescents shortly after vaccination, but this effectiveness decreased significantly over time.

Among adolescents, receiving a booster dose increased vaccine effectiveness to 71.1%, highlighting the importance of booster vaccinations in maintaining protection against COVID-19, especially during the Omicron variant predominance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Prior BNT162b2 COVID-19 Vaccination With Symptomatic SARS-CoV-2 Infection in Children and Adolescents During Omicron Predominance. Fleming-Dutra, KE., Britton, A., Shang, N., et al.[2022]

A study involving 56,436 children aged 5-17 years found that the BNT162b2 vaccine (Comirnaty) is generally safe, with serious adverse events like anaphylaxis and myocarditis occurring at very low rates (0.01%).

Increased risks of mild adverse events such as fatigue, fever, and myalgia were observed after the second dose, particularly in younger children and adolescent males, indicating the need for further investigation into the myocarditis risk in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric safety assessment of BNT162b2 vaccination in a multistate hospital-based electronic health record system in the USA: a retrospective analysis. Matson, RP., Niesen, MJM., Levy, ER., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10848053/

Effectiveness of Bivalent mRNA COVID-19 Vaccines in ... The adjusted bivalent COVID-19 vaccine effectiveness was 58.3% (95% CI, 34.0%-76.5%) for children aged 5 to 11 years and 47.5% (95% CI, 18.2%-

2. thelancet.com thelancet.com/journals/lanres/article/PIIS2213-2600(23)00306-5/fulltext

Effectiveness of BNT162b2 BA.4/5 bivalent mRNA vaccine ... 4/5 bivalent booster (vs unvaccinated individuals) ranged from 56% to 69% against critical illness or hospital admission and showed similar ...

3. academic.oup.com academic.oup.com/jid/article/229/3/648/7334311

Effectiveness of BNT162b2 BA.4/5 Bivalent mRNA Vaccine ... BNT162b2 BA.4/5 bivalent showed early additional protection against Omicron-related symptomatic COVID-19, with hybrid immunity offering greater protection.

4. cdc.gov cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm

Effectiveness of Bivalent mRNA Vaccines in Preventing This report describes the vaccine effectiveness of an updated (bivalent) booster dose in people who have completed their primary series.

5. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-positive-early-data-clinical

Pfizer and BioNTech Announce Positive Early Data From ... A 30-μg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine demonstrated a substantial increase in the Omicron BA.4/BA.5 neutralizing antibody ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11093671/

A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ... In this phase 2/3 trial in ≥12-year-olds who previously received 3 original BNT162b2 doses, immunogenicity and safety data support the favorable benefit-risk ...

7. pfizer.com pfizer.com/news/press-release/press-release-detail/pfizer-and-biontechs-comirnatyr-receives-us-fda-approval

Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA ... Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for ...

8. fda.gov fda.gov/media/151707/download

Package Insert and Patient Package Insert – COMIRNATY Analyses of postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including ... COVID-19. Vaccine, Bivalent (Original and Omicron BA.

9. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/comirnaty

Comirnaty | European Medicines Agency (EMA) Of the 1,005 children receiving the vaccine, none developed COVID-19 compared with 16 children out of the 978 who received placebo. This means that, in this ...