COVID-19 Vaccine for Children

Recruiting at 124 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

3692 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children. The trial is divided into 5 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 5 sub-studies will receive study vaccine as a shot depending on what group they are in. * Substudy A design: Phase 1 includes participants 6 months through less than 4 years 3 months of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial series, followed by a fourth dose of study vaccine. Phase 2/3 includes participants 6 months through less than 5 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive 1, 2, or 3 doses of study vaccine, depending on what group they are in. * Substudy B design: includes participants 6 months through less than 5 years of age who have either received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy C design: Phase 1 includes participants 6 months through less than 5 years of age who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. * Substudy D design: includes participants 5 through less than12 years of age who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose. * Substudy E design: includes participants 2 through less than 12 years of age who have not received a previous coronavirus vaccination (COVID-19 vaccine naive) and will receive a single dose of study vaccine.

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.

What data supports the effectiveness of the COVID-19 vaccine for children?

Research shows that the BNT162b2 COVID-19 vaccine was highly effective in children before the Omicron variant emerged, with a 90% efficacy rate. Although effectiveness against Omicron subvariants was lower, it still provided protection, especially with booster doses. ^{1 2 3 4 5}

How is the Bivalent BNT162b2 Omicron vaccine different from other COVID-19 vaccines for children?

The Bivalent BNT162b2 Omicron vaccine is unique because it specifically targets the Omicron variant of the COVID-19 virus, providing tailored protection for children against this variant. It is an mRNA vaccine, which means it uses a small piece of the virus's genetic material to teach the immune system how to fight the virus. ^{2 4 5 6 7}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

Group XI: 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 XII: 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 XIII: 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 XIV: 3 microgram dose, 2 Years to <5 Years (Substudy E, Group 1) Experimental Treatment 1 Intervention

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

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

Injection in the muscle, 1 dose

Group XXI: 10 microgram dose, 5 Years to <12 Years (Substudy E, Group 2) 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

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. United States 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. [2022]

2. United States 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. [2023]

3. England 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. [2023]

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

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

5. United States 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. [2023]

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

Effectiveness of BNT162b2 COVID-19 Vaccination in Children and Adolescents. [2023]

7. Thailand 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. [2022]