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RecruitingNCT07798648Updated Sep 28, 2026

A Study of COVID-19 Vaccine(s) in Children and Adults

A Phase 3 interventional study of BNT162b2 and BNT162b2 in COVID-19 Vaccines, sponsored by BioNTech SE. Recruiting at 14 sites in United States. Open to participants aged 5 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Primary conditionCOVID-19Registry: PneumoniaReclassifiedWhy we changed it
Registry
Pneumonia — the first condition term the registry derived for this study.
ClinicalTrials.gg
COVID-19
Why
  1. The study's listed conditions name COVID-19, a narrower term within Pneumonia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by BioNTech SE · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.
Updated Sep 28, 2026Now RecruitingFirst site in United States+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study summary

The purpose of this study is to learn about the safety and effects of updated COVID-19 vaccines (called BNT162b2) in participants 5 Through 64 Years of Age with risk factors for Severe COVID-19, and Participants 65 Years of Age and Older.

This study is seeking participants who:

  • are medically stable
  • have not had a recent COVID-19 infection or a recent COVID-19 vaccination
  • have not received certain routine vaccines recently
  • participants that are 5 through 64 years of age will need to have at least 1 medical condition that increase their risk of complications from COVID-19.

Participants in Cohort 1 of this study will receive a single age-appropriate dose (30 mcg for participants aged ≥12 years; 10 mcg for participants aged 5-11 years) of BNT162b2 vaccine 1 which targets COVID-19 (2026/2027 recommended strain) injected in the upper arm. The study team and participants will know which injection they receive.

Participants in Cohort 2 of this study will randomly receive 1 injection into their upper arm of either: BNT162b2 vaccine 1; BNT162b2 vaccine 2, or BNT162b2 vaccine 3 which targets COVID-19. The study team and participants will not know which injection they receive.

Participants will be in the study for about 6 months and will have at least 3 study visits. Participants will record side effects and complete diaries following visit procedures. For Cohort 1 the study team will collect a nose swab and blood samples at 2 of the 3 visits. For Cohort 2 the study team will collect a nose swab and blood samples at all of the visits.

02

Conditions studied

  • COVID-19 Vaccines

Keywords

  • Pneumonia
  • Respiratory Tract Infections
  • Pneumonia,Viral
  • Infections
  • Virus Diseases
  • Coronavirus Infections
  • Coronaviridae Infections
  • Nidovirales Infections
  • RNA Virus Infections
  • Lung Diseases
  • Respiratory Tract Diseases
  • COVID-19
  • mRNA Vaccines
  • Nucleic Acid-Based Vaccine
  • Vaccines, Synthetic
  • Recombinant Proteins
  • Proteins
  • Amino Acids, Peptides, and Proteins
  • Vaccines
  • Biological Products
  • COVID-19 Vaccines
  • Viral Vaccines
  • Antigens
  • Biological Factors
  • BNT162 Vaccine
03

In context

COVID-19 Reclassified

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 700 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

BioNTech SE is the lead sponsor of 76 studies on the registry; 25 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 26 (79%) have results posted.

Browse BioNTech SE studies →

Compared within COVID-19, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pneumonia. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion criteria:

  • Participants 5 years of age or older.
  • Participants 5 through 64 years of age should have at least 1 underlying medical condition that increases their risk of severe COVID-19.

Key Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • History of myocarditis or pericarditis.
  • Receipt of a COVID-19 vaccine or a confirmed case of COVID-19 (confirmed by signs/symptoms and/or a positive test result based on local testing) less than 3 months (90 days) prior to study enrolment.

Refer to the study contact for further eligibility details.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
700 participants (estimated)

Study arms

  • Experimental
    Cohort 1 Group 1: 5-11 Years (with risk factors)

    Participants will receive a single injection (age appropriate dose) on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 1 Group 3: ≥65 Years

    Participants will receive a single injection (age appropriate dose) on Day 1.

    Biological: BNT162b2

  • Experimental
    Cohort 1 Group 2: 12-64 Years (with risk factors)

    Participants will receive a single injection (age appropriate dose) on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 5: 18-64 Years (with risk factors)

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 4: 18-64 Years (with risk factors)

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 6: 18-64 Years (with risk factors)

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 7: ≥65 Years

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 8: ≥65 Years

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

  • Experimental
    Cohort 2 Group 9: ≥65 Years

    Participants will receive a single injection containing variant-adapted BNT162b2 on Day 1

    Biological: BNT162b2

Interventions

  • BiologicalBNT162b2

    BNT162b2 vaccine 1 (2026/2027 recommended strain)

  • BiologicalBNT162b2

    BNT162b2 vaccine 2

  • BiologicalBNT162b2

    BNT162b2 vaccine 3

06

What researchers measure

Primary outcomes

  1. Percentage of participants reporting local reactions or systemic events

    Time frame: For up to 7 days after vaccination

  2. Percentage of participants reporting adverse events

    Time frame: Through 1 month after vaccination

  3. Percentage of participants reporting serious adverse events

    Time frame: Through 6 months after vaccination

  4. Geometric Mean Fold Rise (GMFRs)

    Time frame: From baseline to 1 month after vaccination

Secondary outcomes

  1. Geometric Mean Titers (GMTs)

    Time frame: At baseline and at 1 month after vaccination

  2. Percentage of participants with seroresponse

    Time frame: At 1 month after vaccination

07

Study locations

14 of 14 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Sep 28, 2026
Sites
14 sites added — first site in United States
Show 14 added (14 United States)
  • C & R Research Servcies USA, Inc. · Homestead, United States
  • Indago Research & Health Center, Inc · Miami Lakes, United States
  • AGILE Clinical Research Trials, LLC · Atlanta, United States
  • East-West Medical Research Institute · Honolulu, United States
  • Kentucky Pediatric /Adult Research · Bardstown, United States
  • Dayton Clinical Research · Dayton, United States
  • Senders Pediatrics · South Euclid, United States
  • DM Clinical Research · Philadelphia, United States
  • Cedar Health Research · Dallas, United States
  • Cedar Health Research · Euless, United States
  • DM Clinical Research-Cyfair · Houston, United States
  • DM Clinical Research · Tomball, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic · Salt Lake City, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic South · Salt Lake City, United States
Sep 28, 2026
Primary completion
Apr 20, 2027→Apr 21, 2027
Sep 28, 2026
Study completion
Apr 20, 2027→Apr 21, 2027
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Not yet recruiting→Recruiting
    14 sites added — first site in United States
    Show 14 added (14 United States)
    • C & R Research Servcies USA, Inc. · Homestead, United States
    • Indago Research & Health Center, Inc · Miami Lakes, United States
    • AGILE Clinical Research Trials, LLC · Atlanta, United States
    • East-West Medical Research Institute · Honolulu, United States
    • Kentucky Pediatric /Adult Research · Bardstown, United States
    • Dayton Clinical Research · Dayton, United States
    • Senders Pediatrics · South Euclid, United States
    • DM Clinical Research · Philadelphia, United States
    • Cedar Health Research · Dallas, United States
    • Cedar Health Research · Euless, United States
    • DM Clinical Research-Cyfair · Houston, United States
    • DM Clinical Research · Tomball, United States
    • J. Lewis Research, Inc. / Foothill Family Clinic · Salt Lake City, United States
    • J. Lewis Research, Inc. / Foothill Family Clinic South · Salt Lake City, United States
    Primary completion Apr 20, 2027→Apr 21, 2027
    Study completion Apr 20, 2027→Apr 21, 2027
    + 3 other changes: verification date, description and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07798648
Lead sponsor
BioNTech SE
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Sep 1, 2026
Start date
Aug 31, 2026
Primary completion
Apr 21, 2027 (estimated)
Completion
Apr 21, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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