Biological/Vaccine: BNT162b2 3mcg for COVID-19

1
Effectiveness
2
Safety
Clinical Research Prime, Idaho Falls, ID
COVID-19+1 More
Biological/Vaccine: BNT162b2 3mcg - Biological
Eligibility
< 65
All Sexes
Eligible conditions
COVID-19

Study Summary

A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults

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Eligible Conditions

  • COVID-19
  • Coronavirus Disease 2019 (COVID‑19)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Biological/Vaccine: BNT162b2 3mcg will improve 33 primary outcomes and 26 secondary outcomes in patients with COVID-19. Measurement will happen over the course of From before Dose 1 to each subsequent time point after Dose 2.

Month 1
In Phase 2/3 lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants 12 to <16 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 participants, Geometric Mean Ratio of SARS-CoV-2 neutralizing titers in participants in each age group at selected dose level to those 16 to 25 years of age in study C4591001
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose (2-dose series), the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001
In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001
In lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants 16 to <18 years of age and participants 16 to 55 years of age from C4591001 study
In lower-dose evaluation participants, the difference in percentages of participants with seroresponse in participants 16 to <30 years of age and participants 16 to 55 years of age from C4591001 study
Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants 12 to <16 years of age to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years of age in the C4591001 study
Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥5 to <12 years of age to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years of age in the C4591001 study
Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers in participants 16 to <18 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 55 years from Phase 2/3 of the C4591001 study
Ph 2/3 LDE participants, immunobridging of SARS-CoV-2 serum neutralizing titers in participants 16 to <30 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 55 years from Phase 2/3 of the C4591001 study
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study
Ph 2/3 selected-dose (2-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 in C4591001 study
Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study
Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study
Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in C4591001 study
Month 1
In Phase 2/3 selected-dose (3-dose series), the difference in percentages of participants with seroresponse in participants ≥2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study
In Phase 2/3 selected-dose (3-dose series), the difference in percentages of participants with seroresponse in participants ≥6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001
Ph 2/3 selected-dose (3-dose series), immunobridging of SARS-CoV-2 serum neutralizing titers after 3 doses in participants ≥2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in C4591001 participants 16 to 25 years after 2 doses
Ph 2/3 selected-dose (3-dose), immunobridging SARS-CoV-2 serum neutralizing titers after 3 doses in participants ≥6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in C4591001 participants 16 to 25 in study after 2 doses
At baseline (before Dose 1) and 1, 6, 12 (for the original BNT162b2 group only), and 24 (for the original BNT162b2 group only) months after Dose 2
In evaluable Phase 2/3 participants at selected dose level in each age group, Geometric Mean Titers of SARS-CoV-2 neutralizing titers with no serological or virological evidence of past SARS-CoV-2 infection
At each time point
In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs
Day 7
Ratio of confirmed COVID-19 illness, Ph 2/3 selected-dose in all age groups (with successful immunobridging) and if did not accrue required cases, with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19 illness, Ph 2/3 selected-dose in all age groups (with successful immunobridging) and if did not accrue required cases, without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥6 months to <2 years and ≥2 to <5 years of age with successful immunobridging, without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19, Ph 2/3 selected-dose participants ≥6 months to <2 years and ≥2 to <5 years of age with successful immunobridging, with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Day 7
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥5 to <12 years of age with successful immunobridging, with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥5 to <12 years of age with successful immunobridging, without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Day 7
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥6 months to <5 years of age (3-dose series), evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19 illness, Phase 2/3 selected-dose participants ≥6 months to <5 years of age (3-dose series), with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
From before Dose 1 to each subsequent time point after Dose 2
In evaluable Phase 2/3 participants at the dose level selected in each age group, Geometric Mean Fold Ratio in SARS-CoV-2 serum neutralizing titer from before vaccination to each subsequent time point
Month 6
In the evaluable Phase 2/3 participants, Ratio of incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody seroconversion for the active vaccine group to the placebo group without evidence of past SARS-CoV-2 infection
In the evaluable Phase 2/3 selected-dose participants, Ratio of incidence of asymptomatic SARS-CoV-2 infection based on N-binding antibody seroconversion for the active vaccine group to the placebo group without evidence of past SARS-CoV-2 infection
Day 7
In Phase 1 participants in each age group at each dose level, Geometric Mean Titers of SARS-CoV-2 serum neutralizing antibody titers
Day 7
In Phase 1 participants in each age group at each dose level, Geometric Mean Fold Ratio in SARS-CoV-2 serum neutralizing antibody titers from before vaccination to each subsequent time point
Day 7
Percentage of participants in Phase 1 reporting local reaction in each dose level in each age group
Percentage of participants in Phase 1 reporting local reactions
Percentage of participants in Phase 1 reporting systemic events
Percentage of participants in Phase 1 reporting systemic events in each dose level in each age group
Percentage of participants in Phase 2/3 reporting local reaction
Percentage of participants in Phase 2/3 reporting local reaction in each dose level in each age group
Percentage of participants in Phase 2/3 reporting systemic events
Percentage of participants in Phase 2/3 reporting systemic events in each dose level in each age group
Day 7
Ratio of confirmed COVID-19 illness, in all age groups of Phase 2/3 participants with and without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Ratio of confirmed COVID-19 illness, in all age groups of Phase 2/3 participants without evidence of prior SARS-CoV-2 infection for the active vaccine group to the placebo group
Month 1
Percentage of participants in Phase 1 reporting adverse events
Percentage of participants in Phase 1 reporting adverse events in each dose level in each age group
Percentage of participants in Phase 2/3 reporting adverse events
Percentage of participants in Phase 2/3 reporting adverse events in each dose level in each age group
Month 6
Percentage of participants in Phase 1 reporting serious adverse events
Percentage of participants in Phase 1 reporting serious adverse events in each dose level in each age group
Percentage of participants in Phase 2/3 reporting serious adverse events
Percentage of participants in Phase 2/3 reporting serious adverse events in each dose level in each age group
Month 24
In evaluable Phase 2/3 participants at selected dose level in each age group, Geometric Mean Fold Ratio in SARS-CoV-2 serum neutralizing titer from before vaccination to each subsequent time point

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

31 Treatment Groups

Placebo, ≥2 to <5 Years
Low-Dose, ≥2 to <5 Years
Placebo group

This trial requires 15350 total participants across 31 different treatment groups

This trial involves 31 different treatments. Biological/Vaccine: BNT162b2 3mcg is the primary treatment being studied. Participants will be divided into 26 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 & 3 and have had some early promising results.

Low-Dose, ≥2 to <5 Years
Biological
Low-Dose (3mcg), 2 doses 21 days apart
Low/Mid-Dose, ≥5 to <12 Years
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Mid-Dose, ≥2 to <5 Years
Biological
Mid-Dose, (20mcg), 2 doses 21 days apart
Low-Dose, ≥6 Months to <2 Years
Biological
Low-Dose (3mcg), 2 doses 21 doses apart
High-Dose, ≥2 to <5 Years
Biological
High-Dose, (30mcg), 2 doses 21 days apart
Low/Mid-Dose, 16 to <18 Years (21 day schedule)
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Low/Mid-Dose, 12 to <16 Years (8 week schedule)
Biological
Low/Mid-Dose (10mcg), 2 doses 8 weeks apart
Low/Mid-Dose, 12 to <16 Years (21 day schedule)
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Low/Mid-Dose, 16 to <18 Years (8 week schedule)
Biological
Low/Mid-Dose (10mcg), 2 doses 8 weeks apart
High-Dose, 12 to <16 Years (Troponin I Testing)
Biological
High-Dose (30mcg), 2 doses 21 days apart
Low-Dose, ≥2 to <5 Years (3-dose regimen)
Biological
Low-Dose (3mcg), 3 doses
Low-Dose, ≥6 Months to <2 Years (3-dose regimen)
Biological
Low-Dose (3mcg), 3 doses
High-Dose, ≥5 to <12 Years
Biological
High-Dose (30mcg), 2 doses 21 days apart
Low/Mid-Dose, ≥6 Months to <2 Years
Biological
Low/Mid-Dose, (10mcg), 2 doses 21 days apart
Low-Dose, ≥5 to <12 Years
Biological
Low-Dose (3mcg), 2 doses 21 days apart
Low-dose, 12 to <16 Years
Biological
Low-Dose (3mcg), 2 doses 21 days apart
Mid-Dose, ≥6 Months to <2 Years
Biological
Mid-Dose, (20mcg), 2 doses 21 days apart
Mid-Dose, ≥5 to <12 Years
Biological
Mid-Dose, (20mcg), 2 doses 21 days apart
Low/Mid-Dose, ≥2 to < 5 Years
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Placebo, ≥5 to <12 Years (Troponin I Testing)
Other
A separate cohort of participants to collect serum samples for potential troponin I testing
High-Dose, ≥6 Months to <2 Years
Biological
High-Dose, (30mcg), 2 doses 21 days apart
Low-Dose, 16 to <30 Years
Biological
Low-Dose (3mcg), 2 doses 21 days apart
Low/Mid-Dose, 12 to <16 Years
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
High-Dose, 12 to <16 Years
Biological
High-Dose (30mcg), 2 doses 21 days apart
Low/Mid-Dose, ≥5 to <12 Years (Troponin I Testing)
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart. A separate cohort of participants to collect serum samples for potential troponin I testing
Low/Mid-Dose, 16 to <30 Years
Biological
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Placebo, ≥2 to <5 Years
Other
Placebo, ≥2 to <5 Years (3-dose regimen)
Other
Placebo, ≥6 Months to <2 Years
Other
Placebo, ≥6 Months to <2 Years (3-dose regimen)
Other
Placebo, ≥5 to <12 Years
Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at baseline (before dose 1) and 1, 6, 12 (for the original bnt162b2 group only), and 24 (for the original bnt162b2 group only) months after dose 2
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at baseline (before dose 1) and 1, 6, 12 (for the original bnt162b2 group only), and 24 (for the original bnt162b2 group only) months after dose 2 for reporting.

Closest Location

Clinical Research Prime - Idaho Falls, ID

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for participants ≥12 to <18 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation. For the obtaining-serum-samples-for-potential-troponin I-testing portion of the study: Male or female participants between ≥5 and <16 years of age.
Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in the therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Participants are expected to be available for the duration of the study and whose parent(s)/legal guardian can be contacted by telephone during study participation.
You are a female and are biologically capable of having children. show original
Female participant of childbearing potential or male participant able to father children who is willing to use a highly effective method of contraception as outlined in this protocol for at least 28 days after the last dose of study intervention if at risk of pregnancy with her/his partner; or female participant not of childbearing potential or male participant not able to father children.
The participant or participant's parent(s)/legal guardian is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. Depending on the age of the participant and according to local requirements, participants will also be asked to provide assent as appropriate (verbal or written).

Patient Q&A Section

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

What causes covid-19?

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We found no reliable single pathogen for causing coronaviruses in the outbreak. This suggests that the disease is due to multiple contributing factors. Recent findings suggests that exposure to viruses other than SARS-CoV2 may also trigger the disease. Further research into this is warranted.

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Can covid-19 be cured?

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In the early and middle stages of the SARS-Covvirus 2 infection, people had fewer symptoms including pain by the time of death. This suggests that the virus could be cured by timely treatment. However, in the late stage of the infection, the virus can be cured only by a precise intervention strategy.

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What is covid-19?

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Based on this initial evidence, COVID-19 could evolve into either a deadly coronavirus infections disease associated with severe pulmonary disease or a non-life-threatening respiratory infection with predominantly mild-to-moderate symptoms.

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What are common treatments for covid-19?

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The current study identifies common treatments for an emerging medical condition and provides a simple to-use reference to help patients and their physicians decide what to do for themselves through online referrals.

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How many people get covid-19 a year in the United States?

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In the United States, approximately 0.1 million new patients acquire the disease each year; with an overall estimated death rate of 2.4%, this makes the virus the second most lethal pathogen in the country (next to influenza, although influenza has a much higher fatalities ratio per 1000 infections). The epidemic is concentrated in the elderly population (those with poor health and more severe illnesses), women, and blacks. The majority of cases occur within the United States. As of April 10, 2019, 25 states and the District of Columbia have confirmed cases of the virus in persons either abroad or who visited abroad and tested positive for either a traveler's infection due to visiting a country with a confirmed case or imported infection.

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What are the signs of covid-19?

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In the current situation, the disease can be diagnosed by the symptoms; it does not have any laboratory parameter or imaging study. No imaging study is available in the current situation.

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How serious can covid-19 be?

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The mortality rate among those with COVID-19 that is estimated to be over 20% is comparable with rates in influenza outbreaks of that magnitude. This finding is reassuring, as it confirms the safety of the current countermeasures for the present epidemic. The shortening of the recovery period and the potential future consequences of serious complications are key considerations; however, until research on treatment strategies is ongoing, these findings should be interpreted cautiously.

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What does biological/vaccine: bnt162b2 3mcg usually treat?

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At 1 year the efficacy of Bnt162b2 3mcg was 74%. At year 2 its efficacy increased to 90% The overall vaccine (Bnt162b2 10microg)/antigen (Bnm1 24ng) is the safest and most effective treatment as of now for this disease, based on available evidence.

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What is the average age someone gets covid-19?

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Average age of the first person in the general population to get diagnosed with Covid-19 was 49.3 years (95% CI: 46.4-54.7). Average age of the first person in the healthcare worker population to get diagnosed with Covid-19 was 55.4 years (95% CI: 47.1-63.1). Age distribution analysis revealed that Covid-19 had a skewed age distribution with more people aged 20 years and younger being infected and more people aged 55 years and older being infected. Given the age-distribution in the general population, we believe that those who are between 45 and 55 years old may have a lower risk of being infected with the virus.

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Does covid-19 run in families?

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There is evidence that familial transmission of the virus is possible, and is probably rare due to a lack of evidence of the mutant strains in the rest of the population and low infectiousness of the virus in familial cases. The overall prevalence of the mutant strains in the United States was 1.9%. This suggests that no evidence of a transmission mechanism beyond ordinary infection with the virus exists. It is not clear how frequent the mutant strain is in the domestic pig population, as is the case in wildlife populations, how it spread into the human population, and what the transmission cycle is.

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Has biological/vaccine: bnt162b2 3mcg proven to be more effective than a placebo?

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This is the first study showing bnt162b2 to be more efficient than a placebo treatment in reducing clinical symptoms of H1N1-infected patients, with a duration of 5.5 days of bnt162b2, compared to 4 days of placebo (P =.026). These data could be used for more effective treatment of H1N1 flu in general in primary health care settings, especially when access and availability issues can make access to antiviral treatment difficult or when the treatment is not recommended as first-line therapy of H1N1 infection.

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Have there been any new discoveries for treating covid-19?

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There have never been any new drugs or therapeutic vaccines discovered for treating COVID-19. There are currently no medications that are effective in treating or preventing COVID-19 with certainty. Treatment options for patients on COVID-19 are mostly symptom-based.

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