Other Clinical Trial - A Study to Learn About Variant-Adapted COVID-19 RNA

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Coronavirus Infections
COVID-19
Severe Acute Respiratory Syndrome
Severe Acute Respiratory Syndrome Coronavirus 2

Clinical Trial Details

NCT number	NCT05543616
Study type	Interventional
Source	BioNTech SE
Contact	Pfizer CT.gov Call Center
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 23, 2022
Completion date	August 11, 2025

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT06065033` - Exercise Interventions in Post-acute Sequelae of Covid-19	N/A
Completed	`NCT06267534` - Mindfulness-based Mobile Applications Program	N/A
Completed	`NCT05047601` - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection	Phase 2/Phase 3
Recruiting	`NCT04481633` - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection	N/A
Recruiting	`NCT05323760` - Functional Capacity in Patients Post Mild COVID-19	N/A
Completed	`NCT04612972` - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru	Phase 3
Completed	`NCT04537949` - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults	Phase 1/Phase 2
Recruiting	`NCT05494424` - Cognitive Rehabilitation in Post-COVID-19 Condition	N/A
Active, not recruiting	`NCT06039449` - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2	Phase 3
Enrolling by invitation	`NCT05589376` - You and Me Healthy
Completed	`NCT05158816` - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting	`NCT04341506` - Non-contact ECG Sensor System for COVID19
Completed	`NCT04512079` - FREEDOM COVID-19 Anticoagulation Strategy	Phase 4
Completed	`NCT04384445` - Zofin (Organicell Flow) for Patients With COVID-19	Phase 1/Phase 2
Completed	`NCT05975060` - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.	Phase 2/Phase 3
Active, not recruiting	`NCT05542862` - Booster Study of SpikoGen COVID-19 Vaccine	Phase 3
Terminated	`NCT05487040` - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease	Phase 1
Withdrawn	`NCT05621967` - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation	N/A
Terminated	`NCT04498273` - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80	Phase 3
Active, not recruiting	`NCT06033560` - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms