COVID-19 VaccineNCT05175989
SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following Vaccination Against COVID-19
An observational study of COVID-19 Vaccine, run by Rabin Medical Center at 1 site in Israel.
Trial summary
There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2… Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Jan 2022to 30 Jun 2022
- 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
- Healthy volunteers accepted
- Child
Study population: Children aged 5-11 years eligible for BNT162b2 vaccine
Who may be able to join
- Age 5-11 years
Who cannot join
- Administration of COVID-19 vaccine>21 days prior to enrollment, Contraindication for COVID-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients Congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center
Petah Tikva
Liat Ashkenazi- Hoffnung, MD, 972-3-925-3770, liat.ashkenazi@clalit.org.il
About this study
Official title: Real-world SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following BNT162b2 mRNA Vaccination Against COVID-19: a Prospective Cohort Study
There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.
Read the detailed description
The Pfizer-Biontec BNT162b2 vaccine has proven efficacy and safety for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older. Efficacy and safety were recently shown also for children aged 5-11 years. Side-effects are common, including some rare but important side-effects such as myocarditis. Myocarditis post Pfizer-Biontec BNT162b2 vaccination was described mostly among male adolescents and young adults. There are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years.
This is a prospective cohort study assessing the immunogenicity of the BNT162b2 COVID-19 vaccine in children. The study population will be composed of children aged 5-11 years at the Schneider Children's Medical Center, with no contraindication for COVID-19 vaccination. Upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained.
The study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. The study will last 6 months from the date of the approval of the study protocol.
Blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. Samples will be tested for antibodies to SARS-CoV-2 at the Microbiology Laboratory at the Rabin Medical Center. Symptomatic participants with any respiratory symptoms or other symptoms suggestive of COVID-19 disease will be tested for SARS-CoV-2 by RT-PCR, at laboratories certified by the Ministry of Health.
- Conditions
- COVID-19 Vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of the Pfizer-Biontec BNT162b2 COVID-19 vaccine in children aged 5-11 years. Our second aim is to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children
SARS-CoV-2 serum antibody levels
Measured: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Secondary outcomes (6)
local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years
Description of side effects
Measured: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Evaluation of the long-term immune response following the BNT162b2 vaccine by SARS-CoV-2 serum antibody levels that meet or exceed the threshold of protection From COVID-19
long-term immune response
Measured: Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)].
Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels
Seroresponse rate
Measured: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with medically-attended AEs (MAAEs)
medically-attended AEs
Measured: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with serious adverse events (SAEs)
erious adverse events (SAEs)
Measured: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C)
Adverse Events of Special Interest (AESIs)
Measured: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start10 Jan 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175989
- Sponsor's protocol ID
- 0810-21-RMC
- Status last verified
- Jan 2022
- First submitted
- 30 Dec 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world SARS-CoV-2 Antibody Response in Children Aged 5-11 Years Following BNT162b2 mRNA Vaccination Against COVID-19: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05175989
- Acronym / sponsor ID
- 0810-21-RMC
- Conditions
- COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Jan 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.
There are few data on the immunogenicity of the Pfizer-Biontec BNT162b2 vaccine for the prevention of COVID-19 disease and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years for a period of six and half months following the first dose of the vaccine.
Detailed description
The Pfizer-Biontec BNT162b2 vaccine has proven efficacy and safety for the prevention of COVID-19 disease in adults and adolescents aged 12 years and older. Efficacy and safety were recently shown also for children aged 5-11 years. Side-effects are common, including some rare but important side-effects such as myocarditis. Myocarditis post Pfizer-Biontec BNT162b2 vaccination was described mostly among male adolescents and young adults. There are few data on the immunogenicity of the vaccine and of side effects in children aged 5-11 years. Therefore, our aim is to determine the immunogenicity and to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years.
This is a prospective cohort study assessing the immunogenicity of the BNT162b2 COVID-19 vaccine in children. The study population will be composed of children aged 5-11 years at the Schneider Children's Medical Center, with no contraindication for COVID-19 vaccination. Upon enrollment in the study, participates will be requested to complete an enrollment questionnaire and a blood sample for baseline serological evaluation will be obtained.
The study follow-up period will be 6 and a half months from receipt of the first dose of the vaccine. The study will last 6 months from the date of the approval of the study protocol.
Blood samples for immune response evaluation will be taken at intervals of 28 days (+/- 14) until 6 and a half months from receipt of the first dose of the vaccine. Samples will be tested for antibodies to SARS-CoV-2 at the Microbiology Laboratory at the Rabin Medical Center. Symptomatic participants with any respiratory symptoms or other symptoms suggestive of COVID-19 disease will be tested for SARS-CoV-2 by RT-PCR, at laboratories certified by the Ministry of Health.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 5-11 years eligible for BNT162b2 vaccine
Key inclusion criteria (1 listed)
- Age 5-11 years
Key exclusion criteria (1 listed)
- Administration of COVID-19 vaccine>21 days prior to enrollment, Contraindication for COVID-19 vaccine such as, known hypersensitivity to a component of the vaccine or its excipients Congenital or acquired immunodeficiency (including recipient of systemic steroids ≥2 mg/kg or ≥20mg/day, within two weeks prior to enrollment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunogenicity of the Pfizer-Biontec BNT162b2 COVID-19 vaccine in children aged 5-11 years. Our second aim is to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children
Time frame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
SARS-CoV-2 serum antibody levels
6 secondary outcomes
local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children aged 5-11 years
Time frame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Evaluation of the long-term immune response following the BNT162b2 vaccine by SARS-CoV-2 serum antibody levels that meet or exceed the threshold of protection From COVID-19
Time frame: Day 84 (71-98), day 112 (99-126), day 140 (127-154), day 168 (155-182), day 196 (183-197)].
Seroresponse rate of vaccine recipients (greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum antibody levels
Time frame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with medically-attended AEs (MAAEs)
Time frame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of participants with serious adverse events (SAEs)
Time frame: Up to Day 56 ((day 43 to 70) (28 days +/- 14 days after second injection)
Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C)
Time frame: Up to Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- 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.
1 site 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 Vaccine, run by Rabin Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of the Pfizer-Biontec BNT162b2 COVID-19 vaccine in children aged 5-11 years. Our second aim is to describe the local or systemic reactogenicity events after vaccination with the BNT162b2 COVID-19 vaccine in children (time frame: Day 56 (day 43 to 70) (28 days +/- 14 days after second injection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2022.