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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816643
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : October 7, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

Brief Summary:

This is a Phase 1/2/3 study in healthy children and young adults.

Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants <6 months of age may subsequently be evaluated.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection, COVID-19 Biological: Biological/Vaccine: BNT162b2 10mcg Biological: BNT162b2 20mcg Biological: BNT162b2 30mcg Other: Placebo Biological: Biological/Vaccine: BNT162b2 3mcg Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7922 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN and Young Adults
Actual Study Start Date : March 24, 2021
Estimated Primary Completion Date : June 18, 2024
Estimated Study Completion Date : June 18, 2024

Arm Intervention/treatment
Experimental: Low/Mid-Dose, ≥5 to <12 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level

Experimental: Mid-Dose, ≥5 to <12 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
Biological: BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level

Experimental: High-Dose, ≥5 to <12 Years
High-Dose (30mcg), 2 doses 21 days apart
Biological: BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level

Experimental: Low/Mid-Dose, ≥2 to < 5 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level

Experimental: Mid-Dose, ≥2 to <5 Years
Mid-Dose, (20mcg), 2 doses 21 days apart
Biological: BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level

Experimental: High-Dose, ≥2 to <5 Years
High-Dose, (30mcg), 2 doses 21 days apart
Biological: BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level

Experimental: Low/Mid-Dose, ≥6 Months to <2 Years
Low/Mid-Dose, (10mcg), doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level

Experimental: Mid-Dose, ≥6 Months to <2 Years
Mid-Dose, (20mcg), doses 21 days apart
Biological: BNT162b2 20mcg
BNT162b2 Mid-Dose (20mcg) level

Experimental: High-Dose, ≥6 Months to <2 Years
High-Dose, (30mcg), 2 doses 21 days apart
Biological: BNT162b2 30mcg
BNT162b2 High-Dose (30mcg) level

Experimental: Low-Dose, ≥5 to <12 Years
Low-Dose (3mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (10mcg) level

Experimental: Low-Dose, 16 to <30 Years
Low-Dose (3mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (10mcg) level

Experimental: Low/Mid-Dose, 16 to <30 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level

Placebo Comparator: Placebo, ≥6 Months to <2 Years Other: Placebo
Intramuscular injection

Placebo Comparator: Placebo, ≥2 to <5 Years Other: Placebo
Intramuscular injection

Placebo Comparator: Placebo, ≥5 to <12 Years Other: Placebo
Intramuscular injection

Experimental: Low-Dose, ≥6 Months to <2 Years
Low-Dose (3mcg), 2 doses 21 doses apart
Biological: Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (10mcg) level

Experimental: Low-Dose, ≥2 to <5 Years
Low-Dose (3mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (10mcg) level

Experimental: Low-dose, 12 to <16 Years
Low-Dose (3mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 3mcg
BNT162b2 Low-Dose (10mcg) level

Experimental: Low/Mid-Dose, 12 to <16 Years
Low/Mid-Dose (10mcg), 2 doses 21 days apart
Biological: Biological/Vaccine: BNT162b2 10mcg
BNT162b2 Low/Mid-Dose (10mcg) level




Primary Outcome Measures :
  1. Percentage of participants in Phase 1 reporting local reactions [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
    Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.

  2. Percentage of participants in Phase 1 reporting systemic events [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened join pain, decreased appetite drowsiness, and irritability as reported on electronic diaries

  3. Percentage of participants in Phase 1 reporting adverse events [ Time Frame: from Dose 1 through 1 month after the last dose ]
    As elicited by investigational site staff

  4. Percentage of participants in Phase 1 reporting serious adverse events [ Time Frame: from Dose 1 through 6 months after the last dose ]
    As elicited by investigational site staff

  5. Percentage of participants in Phase 2/3 reporting local reaction [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
    Pain or tenderness at the injection site, redness and swelling as reported on electronic diaries.

  6. Percentage of participants in Phase 2/3 reporting systemic events [ Time Frame: for 7 days after Dose 1 and Dose 2 ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, new or worsened joint pain, decreased appetite, drowsiness, and irritability as reported on electronic diaries

  7. Percentage of participants in Phase 2/3 reporting adverse events [ Time Frame: from Dose 1 through 1 month after the last dose ]
    As elicited by investigational site staff

  8. Percentage of participants in Phase 2/3 reporting serious adverse events [ Time Frame: from Dose 1 through 6 months after the last dose ]
    As elicited by investigational site staff

  9. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  10. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  11. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  12. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  13. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  14. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory


Secondary Outcome Measures :
  1. In Phase 1 participants, SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs [ Time Frame: Through 7 days after Dose 2 ]
    As measured at the central laboratory

  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 [ Time Frame: 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 ]
    As measured at the central laboratory

  3. 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 [ Time Frame: From before Dose 1 to each subsequent time point after Dose 2 ]
    As measured at the central laboratory

  4. 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 [ Time Frame: Through 6 months after the second dose ]
    As measured at the central laboratory

  5. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  6. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  7. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  8. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  9. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  10. 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 [ Time Frame: 1 month after the second dose ]
    As measured at the central laboratory

  11. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up

  12. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up

  13. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up

  14. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up

  15. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up

  16. 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 [ Time Frame: From 7 days after the second dose ]
    Per 1000 person-years of follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. 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 ≥5 to <30 years of age, at the time of randomization, at Visit 1 for the lower-dose evaluation.
  2. 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.
  3. 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.

  4. 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.
  5. Negative urine pregnancy test for female participants who are biologically capable of having children.
  6. 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.
  7. 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).

Exclusion Criteria

  1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
  2. Phase 1 only: Known infection with HIV, HCV, or HBV.
  3. Receipt of medications intended to prevent COVID-19.
  4. Previous or current diagnosis of MIS-C.
  5. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Note: This includes both conditions that may increase the risk associated with study intervention administration or a condition that may interfere with the interpretation of study results
  6. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  7. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  8. Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to systemic lupus erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
  9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  10. Female who is pregnant or breastfeeding.
  11. Previous vaccination with any coronavirus vaccine.
  12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or receipt of any passive antibody therapy specific to COVID-19 from 90 days before study intervention administration, or planned receipt throughout the study.
  14. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
  15. Previous participation in other studies involving study intervention containing LNPs.
  16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816643


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 94 study locations
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04816643    
Other Study ID Numbers: C4591007
2020-005442-42 ( EudraCT Number )
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
COVID-19
Coronavirus Vaccine
SARS-CoV-2
RNA Vaccine
mRNA Vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs