10 microgram dose, 5 to <12 Years (Substudy D, Group 1) for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
COVID19 (disease)+8 More
Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose - Biological
Eligibility
< 18
All Sexes
What conditions do you have?
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Study 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 bivalent BNT162b2 Omicron containing vaccine) in healthy children. The trial is divided into 4 individual studies or substudies based on age group and prior history of COVID-19 vaccinations. All participants in each of the 4 sub-studies study vaccine as a shot depending on what group they are in. Substudy A design: includes participants 6 months through 23 months who have not received a previous coronavirus vaccination (COVID-19 vaccine naïve) and will receive 3 doses of study vaccine as their initial which may be followed by a fourth dose of study vaccine. Substudy B design: includes 6 months through 4 years 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: includes participants 6 months through 4 years who have received 3 prior doses of BNT162b2 and will receive study vaccine as their fourth dose. Substudy D design: includes participants 5 through 12 years who have received 2 or 3 prior doses of BNT162b2 and will receive study vaccine as their third or fourth dose.

Eligible Conditions
  • COVID19 (disease)
  • COVID-19
  • Severe Acute Respiratory Syndrome Coronavirus 2
  • SARS-CoV-2 Virus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

39 Primary · 15 Secondary · Reporting Duration: Group 1: At baseline (before Dose 1), 1 month after Dose 1 and 1 month after Dose 2; Groups 2 and 3: At baseline (before Dose 1) and 1 month after Dose 1

Month 1
SSC - Ph 1 dose finding, percentage of participants reporting adverse events
SSC - Ph 2/3 selected dose - percentage of participants reporting adverse events
SSD - percentage of participants reporting adverse events
Month 6
SSC - Ph 1 dose finding, percentage of participants reporting serious adverse events
SSC - Ph 2/3 selected dose - percentage of participants reporting serious adverse events
SSD - percentage of participants reporting serious adverse events
Month 1
SSC - Ph 1 dose finding - geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSC - Ph 1 dose finding - geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSC - Ph 1 dose finding - percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSC - Ph 2/3 selected dose - geometric mean fold ratio elicited by bivalent BNT162b2 at the selected dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSC - Ph 2/3 selected dose - geometric mean titers elicited by bivalent BNT162b2 at the selected dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSC - Ph 2/3 selected dose - percentages of participants with seroresponse elicited by bivalent BNT162b2 at the selected dose level given as a fourth dose in participants ≥6 months to <5 years of age
SSD - geometric mean fold rise elicited by bivalent BNT162b2 given as a third or fourth dose in participants ≥5 to <12 years of age
SSD - geometric mean titers elicited by bivalent BNT162b2 given as a third or fourth dose in participants ≥5 to <12 years of age
SSD - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as a third or fourth dose in participants ≥5 to <12 years of age
Month 1
SSA - Ph 1 dose finding, geometric mean fold rise elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants ≥6 months to <2 years of age
SSA - Ph 1 dose finding, geometric mean titers elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants ≥6 months to <2 years of age
SSA - Ph 1 dose finding, percentage of participants with seroresponse elicited by prophylactic bivalent BNT162b2 at each dose level in COVID-19 vaccine-naïve participants ≥6 months to <2 years of age
Month 1
SSA - Ph 2/3 dose finding, geometric mean fold rise elicited by bivalent BNT162b2 in participants ≥6 months to <2 years of age
SSA - Ph 2/3 dose finding, geometric mean titers elicited by bivalent BNT162b2 in participants ≥6 months to <2 years of age
SSA - Ph 2/3 dose finding, percentages of participants with seroresponse elicited by bivalent BNT162b2 in participants ≥6 months to <2 years of age
Month 1
SSB - geometric mean fold rise elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age
SSB - geometric mean titers elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age
SSB - percentages of participants with seroresponse elicited by bivalent BNT162b2 given as third and/or fourth dose in participants ≥6 months <5 years of age
Month 1
SSA - Ph 2/3 selected dose, noninferiority with respect to seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <2 years of age
Month 1
SSA - Ph 2/3 selected dose, superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <2 years of age
Month 1
SSA - Ph 2/3 selected dose, noninferiority with respect to the the seroresponse rate to the Omicron BA.4/BA.5 strain in participants ≥6 months to <2 years of age
SSA - Ph 2/3 selected dosed, superiority with respect to ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <2 years of age
Month 1
SSC - Ph 2/3 selected dose - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain for participants ≥6 months to <5 years of age
Year 5
SSB - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥6 months to <5 years of age
Month 1
SSC - Ph 2/3 selected dose - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age
Year 5
SSB - ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥6 months to <5 years of age
Month 1
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain in participants ≥5 to <12 years of age
Month 1
SSD - the ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age
Month 1
SSD - difference in percentages of participants with seroresponse to the Omicron BA.4/BA.5 strain participants ≥5 to <12 years of age
SSD - ratio of the geometric mean of SARS-CoV-2 Omicron BA.4/BA.5-neutralizing titers in participants ≥5 to <12 years of age
Day 7
SSC - Ph 1 dose finding, percentage of participants reporting systemic events
SSC - Ph 2/3 selected dose, percentage of participants reporting local reactions
SSC - Ph 2/3 selected dose, percentage of participants reporting systemic events
SSD - percentage of participants reporting systemic events
Substudy C (SSC) - Ph 1 dose finding, percentage of participants reporting local reactions
Substudy D (SSD) - percentage of participants reporting local reactions
Day 7
SSB - percentage of participants reporting systemic events
Substudy B (SSB) - percentage of participants reporting local reactions
Day 7
SSA - Ph 1 dose finding, percentage of participants reporting systemic events
SSA - Ph 2/3 selected dose, percentage of participants reporting local reactions
SSA - Ph 2/3 selected dose, percentage of participants reporting systemic events
Substudy A (SSA) - Ph 1 dose finding, percentage of participants reporting local reactions
Month 1
SSA - Ph 1 dose finding, percentage of participants reporting adverse events
SSA - Ph 2/3 selected dose, percentage of participants reporting adverse events
Month 6
SSA - Ph 1 dose finding, percentage of participants reporting serious adverse events
SSA - Ph 2/3 selected dose, percentage of participants reporting serious adverse events
SSB - percentage of participants reporting serious adverse events
Month 1
SSB - percentage of participants reporting adverse events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

14 Treatment Groups

10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
1 of 14
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
1 of 14
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
1 of 14
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
1 of 14
10 microgram dose, 6 Months to <5 Years (Substudy C, Phase 1)
1 of 14
6 microgram dose, 6 Months to <5 Years (Substudy C, Phase 1)
1 of 14
Selected dose, 6 Months to <5 Years (Substudy C, Phase 2/3)
1 of 14
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3) - 0/8/16 week primar...
1 of 14
6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
1 of 14
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
1 of 14
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
1 of 14
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
1 of 14
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3) - 0/3/11 week primar...
1 of 14
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
1 of 14

Experimental Treatment

2270 Total Participants · 14 Treatment Groups

Primary Treatment: 10 microgram dose, 5 to <12 Years (Substudy D, Group 1) · No Placebo Group · Phase 2 & 3

10 microgram dose, 5 to <12 Years (Substudy D, Group 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose · Intervention Types: Biological
10 microgram dose, 5 to <12 Years (Substudy D, Group 3)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose · Intervention Types: Biological
3 microgram dose, 6 Months to <4 Years 6 Months (Substudy B, Group 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose · Intervention Types: Biological
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 2)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose · Intervention Types: Biological
10 microgram dose, 6 Months to <5 Years (Substudy C, Phase 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose · Intervention Types: Biological
6 microgram dose, 6 Months to <5 Years (Substudy C, Phase 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose · Intervention Types: Biological
Selected dose, 6 Months to <5 Years (Substudy C, Phase 2/3)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) Substudy C Ph 2/3 Selected Dose · Intervention Types: Biological
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3) - 0/8/16 week primary series
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) Substudy A Ph 2/3 Selected Dose · Intervention Types: Biological
6 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose · Intervention Types: Biological
3 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose · Intervention Types: Biological
10 microgram dose, 5 to <12 Years (Substudy D, Group 2)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose · Intervention Types: Biological
10 microgram dose, 6 Months to <2 Years (Substudy A, Phase 1)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose · Intervention Types: Biological
Selected dose, 6 Months to <2 Years (Substudy A, Phase 2/3) - 0/3/11 week primary series
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) Substudy A Ph 2/3 Selected Dose · Intervention Types: Biological
3 microgram dose, 6 Months to <5 Years (Substudy B, Group 3)
Biological
Experimental Group · 1 Intervention: Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: group 1: at baseline (before dose 1), 1 month after dose 1 and 1 month after dose 2; groups 2 and 3: at baseline (before dose 1) and 1 month after dose 1

Who is running the clinical trial?

PfizerIndustry Sponsor
4,263 Previous Clinical Trials
7,105,873 Total Patients Enrolled
BioNTech SELead Sponsor
51 Previous Clinical Trials
88,997 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,251 Previous Clinical Trials
4,821,383 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a substudy A.
You are 6 months to 2 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.