Evidence map›Paper›PMID 36929216›Full record

Trial reportJournal of the Pediatric Infectious Diseases Society2023

Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds.

Eric A F Simões, Nicola P Klein, Charu Sabharwal, Alejandra Gurtman, Nicholas Kitchin, Benita Ukkonen, Piotr Korbal, Jing Zou, Xuping Xie, Uzma N Sarwar and 13 more

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of the Pediatric Infectious Diseases Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04816643 (A 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), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04816643 phase3completednot on this map

A 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

TypeinterventionalSponsorBioNTech SERan2021 to 2023Enrolled11,837ConditionsSARS-CoV-2 Infection, COVID-19ArmsBiological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg, Placebo, Biological/Vaccine: BNT162b2 3mcg
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Eric A F SimõesChildren's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO, USA.
Nicola P KleinKaiser Permanente Vaccine Study Center, Kaiser Permanente Northern California, Oakland, CA, USA.
Charu SabharwalVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Alejandra GurtmanVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Nicholas KitchinVaccine Research and Development, Pfizer Ltd, Hurley, UK.
Benita UkkonenEspoo Vaccine Research Clinic, Tampere University, Espoo, Finland.
Piotr KorbalOśrodek Badań Klinicznych In-Vivo, Bydgoszcz-Toruń, Poland.
Jing ZouDepartment of Biochemistry and Molecular Biology, University of Texas Medical Branch, Galveston, TX, USA.
Xuping XieDepartment of Biochemistry and Molecular Biology, University of Texas Medical Branch, Galveston, TX, USA.
Uzma N SarwarVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Xia XuVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Stephen LockhartVaccine Research and Development, Pfizer Ltd, Hurley, UK.
Luke CunliffeVaccine Research and Development, Pfizer Ltd, Hurley, UK.
Claire LuVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Hua MaVaccine Research and Development, Pfizer Inc, Collegeville, PA, USA.
Kena A SwansonVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Kenneth KouryVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Pei-Yong ShiDepartment of Biochemistry and Molecular Biology, University of Texas Medical Branch, Galveston, TX, USA.
David CooperVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Ӧzlem TüreciBioNTech, Mainz, Germany.
Kathrin U JansenVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.
Uğur ŞahinBioNTech, Mainz, Germany.
William C GruberVaccine Research and Development, Pfizer Inc, Pearl River, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this ongoing study, substantially increased ancestral SARS-CoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose given to 5 to 11-year olds versus neutralizing responses post-dose 2. After dose 3, increased neutralizing responses against Omicron BA.1 and BA.4/BA.5 strains were also observed. The safety/tolerability profile was acceptable. (NCT04816643).

Indexed as

BNT162 VaccineCOVID-19Antibodies, ViralHumansImmunogenicity, VaccinemRNA VaccinesSARS-CoV-2Antibodies, ViralBNT162 VaccinemRNA VaccinesBNT162b2 vaccineboosterchildrenCOVID-19immunogenicitysafety

Identifiers

PMID36929216
PMCPMC10146923

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.