A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil

An observational study of COVID-19, run by Hospital Moinhos de Vento at 5 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences among children aged 5 to 11 years in the city of Toledo in Southern Brazil. Read more about this study

Who is it for?: Ages 5 to 11 years
Conditions the study is for: COVID-19
What is being tested?: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine and CoronaVac COVID-19 vaccine
Type of treatment: Vaccines
How many people: 757 participants
Where: 5 sitesBrazil
Study dates: 8 Jun 2022to 17 Jul 2023
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 11 years
All sexes
Child

Study population: The present study population will be composed by individuals aged 5 to 11 years who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. Participants with a positive RT-PCR test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls.

Who may be able to join

Age between 5 and 11 years;
Resident of Toledo city;
Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
Nasal or nasopharyngeal sample for SARS-CoV-2 test obtained as standard of care.

Who cannot join

SARS-CoV-2-directed antiviral treatment within the past 30 days;
COVID-19 monoclonal antibody therapy within the past 90 days;
COVID-19 convalescent serum therapy within the past 90 days;
Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

Jardim Coopagro
Toledo, Paraná
Jardim Cosmos primary healthcare unit
Toledo, Paraná
Jardim Maracanã
Toledo, Paraná
Jardim Porto Alegre
Toledo, Paraná
Pediatric Emergency Service
Toledo, Paraná

Other trials in Brazil

About this study

Official title: A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil

Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.

Conditions: COVID-19
Being tested: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine, CoronaVac COVID-19 vaccine
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineBiological
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
CoronaVac COVID-19 vaccineBiological
CoronaVac COVID-19 vaccine

Study groups in NCT05403307
Study group	Role	What they receive
Two doses or more of BNT162b2		Defined as ≥ 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective. Receives: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
One dose of BNT162b2		Defined as 1 dose (only) of Pfizer/BioNTech BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset. Receives: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
One dose or more of BNT162b2		Defined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset. Receives: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Two doses of BNT162b2		Defined as 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. Receives: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Three doses of BNT162b2		Defined as 3 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 3rd dose and acute respiratory illness (ARI) symptom onset. Receives: Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
Fully vaccinated with other available COVID-19 vaccines		Defined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations. Receives: Biological: CoronaVac COVID-19 vaccine
Never vaccinated		Defined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses.

What is being measured

The primary outcome is the main question the study is designed to answer.

Odds of symptomatic SARS-CoV-2 infection
Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
Measured: At the moment of enrollment

Secondary outcomes (9)

Odds of symptomatic SARS-CoV-2 infection due to Omicron variant
Odds of symptomatic SARS-CoV-2 infection due to Omicron variant defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 Omicron variant
Measured: At the moment of enrollment
Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern
Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2 variants of concern.
Measured: At the moment of enrollment
Duration of COVID-19 symptoms
Length of COVID-19-related symptoms
Measured: within 90 days from enrollment
Incidence of hospitalization due to COVID-19
Incidence of hospital admission due to COVID-19
Measured: Within 90 days from enrollment
Incidence of PICU admission
Incidence of Pediatric intensive care unit admission
Measured: Within 90 days from enrollment
Incidence of invasive mechanical ventilation
Incidence of invasive mechanical ventilation
Measured: Within 90 days from enrollment
Incidence of multisystem inflammatory syndrome
Incidence of multisystem inflammatory syndrome
Measured: Within 90 days from enrollment
Mortality due to COVID-19
Incidence of COVID-19-related mortality
Measured: Within 90 days from enrollment
Prevalence of long COVID-19 symptoms at 3 months
Prevalence of long COVID-19-related symptoms (fatigue, muscular weakness, dyspnea, cough, loss of taste or smell, concentration or memory difficulties, sleep disorders, headache)
Measured: Within 90 days from enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202217 Jul 2023

First posted3 Jun 2022
Study start8 Jun 2022
Primary completion30 Apr 2023
Study completion17 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 757 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05403307
Sponsor's protocol ID: BNT162b2 pediatric Toledo
Status last verified: May 2022
First submitted: 27 May 2022
Last updated: 7 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Rodrigues CO, Spinardi J, Rosa RG, Falavigna M, de Souza EM, Manfio JL, de Souza AP, de Araujo CLP, Cohen M, Barbosa GRGDV, Silva FKR, Sganzerla D, da Silva MMD, Ferreira D, Kunkel NT, Camargo NI, Sarturi JC, Guilhem MC, de Oliveira JC, Lopes CC, Widmar F, Barufi LK, da Silva GN, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Baura VA, Abreu H, Poitevin CG, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Castillo GDCM, McLaughlin JM; Toledo BNT162b2 Study Group Investigators. Real-world effectiveness of original BNT162b2 mRNA COVID-19 against symptomatic Omicron infection among children 5-11 years of age in Brazil: A prospective test-negative design study. Immunol Lett. 2024 Oct;269:106903. doi: 10.1016/j.imlet.2024.106903. Epub 2024 Jul 26.
PubMed 39069096

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children Aged 5 to 11 Years in Brazil
ClinicalTrials.gov ID: NCT05403307
Acronym / sponsor ID: BNT162b2 pediatric Toledo
Conditions: COVID-19
Study type: Observational
Recruitment status: Completed
Enrolment: 757 participants (actual)
Lead sponsor: Hospital Moinhos de VentoUniversity, hospital or other
Collaborators: Universidade Federal do Paraná, Pfizer, Inova Medical
Study start: 8 Jun 2022 (actual)
Primary completion: 30 Apr 2023 (actual)
Study completion: 17 Jul 2023 (actual)
First posted: 3 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 7

Arm	Type	Receives
Two doses or more of BNT162b2	–	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDefined as ≥ 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset. This group will serve as the 'exposed' group evaluated in the primary objective.
One dose of BNT162b2	–	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDefined as 1 dose (only) of Pfizer/BioNTech BNT162b2 COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
One dose or more of BNT162b2	–	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDefined as ≥1 dose of Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine received with ≥14 days between receipt of the 1st dose and ARI symptom onset.
Two doses of BNT162b2	–	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDefined as 2 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 2nd dose and acute respiratory illness (ARI) symptom onset.
Three doses of BNT162b2	–	Biological: Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccineDefined as 3 doses of BNT162b2 COVID-19 vaccine received with ≥7 days between receipt of the 3rd dose and acute respiratory illness (ARI) symptom onset.
Fully vaccinated with other available COVID-19 vaccines	–	Biological: CoronaVac COVID-19 vaccineDefined as fully vaccinated with available COVID-19 vaccines according to Brazil National Immunization Program recommendations.
Never vaccinated	–	–Defined as never received any COVID-19 vaccine. This group will serve as the reference exposure group (i.e., 'unexposed' group) in all vaccine effectiveness analyses.

Who may qualify

Ages: 5 to 11 years
Sex: All
Age groups: Child
Study population: The present study population will be composed by individuals aged 5 to 11 years who seek the public healthcare system of Toledo city with symptoms suggestive COVID-19. Participants with a positive RT-PCR test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls.

Key inclusion criteria (4 listed)

Age between 5 and 11 years;
Resident of Toledo city;
Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
Nasal or nasopharyngeal sample for SARS-CoV-2 test obtained as standard of care.

Key exclusion criteria (4 listed)

SARS-CoV-2-directed antiviral treatment within the past 30 days;
COVID-19 monoclonal antibody therapy within the past 90 days;
COVID-19 convalescent serum therapy within the past 90 days;
Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccinePfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine	Biological	One dose of BNT162b2, One dose or more of BNT162b2, Three doses of BNT162b2, Two doses of BNT162b2, Two doses or more of BNT162b2
CoronaVac COVID-19 vaccineCoronaVac COVID-19 vaccine	Biological	Fully vaccinated with other available COVID-19 vaccines

Primary outcome

Odds of symptomatic SARS-CoV-2 infection
Time frame: At the moment of enrollment
Odds of symptomatic SARS-CoV-2 infection defined by the presence of symptoms suggestive COVID-19 with a positive RT-PCR test for SARS-CoV-2. Symptoms suggestive of COVID-19 are defined as follows: 1) Acute respiratory illness symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).

9 secondary outcomes

Odds of symptomatic SARS-CoV-2 infection due to Omicron variant
Time frame: At the moment of enrollment
Odds of symptomatic SARS-CoV-2 infection due to other circulating variants of concern
Time frame: At the moment of enrollment
Duration of COVID-19 symptoms
Time frame: within 90 days from enrollment
Incidence of hospitalization due to COVID-19
Time frame: Within 90 days from enrollment
Incidence of PICU admission
Time frame: Within 90 days from enrollment
Incidence of invasive mechanical ventilation
Time frame: Within 90 days from enrollment
Incidence of multisystem inflammatory syndrome
Time frame: Within 90 days from enrollment
Mortality due to COVID-19
Time frame: Within 90 days from enrollment
Prevalence of long COVID-19 symptoms at 3 months
Time frame: Within 90 days from enrollment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Derived from this study: PubMed 39069096Rodrigues CO, Spinardi J, Rosa RG, Falavigna M, de Souza EM, Manfio JL, de Souza AP, de Araujo CLP, Cohen M, Barbosa GRGDV, Silva FKR, Sganzerla D, da Silva MMD, Ferreira D, Kunkel NT, Camargo NI, Sarturi JC, Guilhem MC, de Oliveira JC, Lopes CC, Widmar F, Barufi LK, da Silva GN, Gradia DF, Brandalize APC, Royer CA, Luiz RM, Baura VA, Abreu H, Poitevin CG, Kucharski GA, Pedrotti F, Valluri SR, Srivastava A, Juliao VW, Melone OC, Allen KE, Kyaw MH, Castillo GDCM, McLaughlin JM; Toledo BNT162b2 Study Group Investigators. Real-world effectiveness of original BNT162b2 mRNA COVID-19 against symptomatic Omicron infection among children 5-11 years of age in Brazil: A prospective test-negative design study. Immunol Lett. 2024 Oct;269:106903. doi: 10.1016/j.imlet.2024.106903. Epub 2024 Jul 26.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Regis G Rosa, MD, PhD principal investigator

Hospital Moinhos de Vento, INOVA

Maicon Falavigna, MD, PhD principal investigator

Hospital Moinhos de Vento, INOVA

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Hospital Moinhos de Vento at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds of symptomatic SARS-CoV-2 infection (time frame: At the moment of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.