Vaccine ReactionPhase 4NCT05329064
Determining Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children
A Phase 4 study testing BNT162b2 Pfizer-BioNTech/Comirnaty in people with Vaccine Reaction and COVID-19, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial summary
COVID-19 vaccine response data in children 5 to 11 years old remain scarce. Our understanding of the safety and immune responses including humoral and cellular responses generated in children remains limited. Safety of the vaccine is critical in the risk benefit assessment of vaccination in young children. Read more about this study
- Who is it for?
- Ages 5 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction, COVID-19, Children, Only
- What is being tested?
- BNT162b2 Pfizer-BioNTech/Comirnaty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Mar 2022to 31 Dec 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Healthy children aged 5 to 11 years old
- No contraindications to mRNA COVID-19 Pfizer-BioNTech vaccines
- Had never received any COVID-19 vaccine before
- Never had previous COVID-19 infections
Who cannot join
- Children outside the age group.
- Immunocompromised children.
- Participants with previous history of COVID-19 infection.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Bukit Timah, 229899
Qing Lin Tan, +6563948696, tan.qing.lin@kkh.com.sg
Chee Fu Yung
About this study
Official title: A Single Arm Phase-IV Study to Determine Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children
COVID-19 vaccine response data in children 5 to 11 years old remain scarce. Our understanding of the safety and immune responses including humoral and cellular responses generated in children remains limited.
Safety of the vaccine is critical in the risk benefit assessment of vaccination in young children. Available data show a trend for increased risk of myocarditis after second dose, especially in males and younger age groups. It is unknown if reduced antigen dose will alter this risk in 5y to <12y age group. Reassuringly, data from early roll-out in the USA have not reported any safety signals to date. Alternate (reduce dosing or delayed dosing) strategies could help ensure maximum protection with reduced risk of side-effects. There is currently no data available to inform how long protection would last in the reduced dose or delayed dosing strategy.
The trial will inform the potential use of alternate dosing schedules such as single dose or delayed dose to minimise risk and maximise benefit of COVID-19 vaccination in children 5 to 11 years old.
Read the detailed description
BNT162b2 (Pfizer-BioNTech/Comirnaty®) vaccine is a mRNA vaccine that is (26/11/2021) approved for use in adults and adolescents (12 years old and above) under the Pandemic Special Access Route (PSAR) by the Health Sciences Authority (HSA), Singapore.1 Two doses of vaccine (30mcg) given 3 weeks apart was shown to be > 95% effective in the prevention of symptomatic COVID-19 infection.2 The latest phase 3 trial of the vaccine using a lower (10 mcg) two dose schedule (3 weeks apart) in children aged 5 to 11 year old was found to be > 90% effective.
Older age groups and those with comorbidities such as obesity, diabetes mellitus, etc are at highest risk of severe COVID-19 disease. Currently, recommendations for vaccination have been extended to adolescents in Singapore as well as many countries including the USA, Israel and Ireland, in view of the high rates of infection in this age group. On 29 October 2021, the FDA authorised the use of BNT162b2 Pfizer-BioNTech/Cominarty vaccine for emergency use in children 5 to 11 years old.4 Subsequently, the CDC recommended COVID-19 vaccination of children 5 to 11 years old in the USA using intramuscular 10mcg of BNT162b2 Pfizer-BioNTech/Comirnaty®) vaccine given 3 weeks apart.
A key concern regarding paediatric vaccination is a rare side effect of inflammation of the heart muscle (myocarditis) that has been observed after receipt of the second dose of BNT162b2,especially in younger age groups including adolescents and males. Centre for Disease Control (CDC), USA reported that there were 9.8 cases of myocarditis per million first doses given and this rose to 67 per million after the second dose. Most cases of myocarditis were benign and self-limiting but long-term impact remains uncertain.
There are possible alternatives to a standard two dose schedule given 21 days apart which may help reduce the risk of adverse events such as myocarditis. The extended interval between doses had been shown in the UK to result in improved immunogenicity in adults. The optimum timing of such a delayed dosing schedule remains unknown in children and identifying the best timing to help delay the need for boosters in children will be useful.
- Conditions
- Vaccine Reaction, COVID-19, Children, Only
- Being tested
- BNT162b2 Pfizer-BioNTech/Comirnaty
- Keywords
- COVID-19, Vaccine, Children
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2 Pfizer-BioNTech/ComirnatyBiological
The study will use 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose.
Two doses will be given at 2 months apart between doses.
| Study group | Role | What they receive |
|---|---|---|
| 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) | Other | 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose. Two doses will be given at 2 months apart between doses. Receives: Biological: BNT162b2 Pfizer-BioNTech/Comirnaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage neutralizing antibody levels at 2m
Measured: 2 Months
WHO International units/ml neutralizing antibody levels at 2m
Measured: 2 Months
Geometric mean titres (GMT) neutralizing antibody levels at 2m
Measured: 2 Months
Secondary outcomes (3)
Percentage neutralizing antibody levels at 6m and 9 to 12m
Measured: 12 Months
WHO International units/ml neutralizing antibody levels at 6m and 9 to 12m
Measured: 12 Months
GMT neutralizing antibody levels at 6m and 9 to 12m
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start24 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329064
- Sponsor's protocol ID
- 2022/2003
- Status last verified
- Mar 2022
- First submitted
- 11 Apr 2022
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase-IV Study to Determine Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children
- ClinicalTrials.gov ID
- NCT05329064
- Acronym / sponsor ID
- 2022/2003
- Conditions
- Vaccine Reaction, COVID-19, Children, Only
- Keywords
- COVID-19, Vaccine, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Apr 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.
COVID-19 vaccine response data in children 5 to 11 years old remain scarce. Our understanding of the safety and immune responses including humoral and cellular responses generated in children remains limited.
Safety of the vaccine is critical in the risk benefit assessment of vaccination in young children. Available data show a trend for increased risk of myocarditis after second dose, especially in males and younger age groups. It is unknown if reduced antigen dose will alter this risk in 5y to <12y age group. Reassuringly, data from early roll-out in the USA have not reported any safety signals to date. Alternate (reduce dosing or delayed dosing) strategies could help ensure maximum protection with reduced risk of side-effects. There is currently no data available to inform how long protection would last in the reduced dose or delayed dosing strategy.
The trial will inform the potential use of alternate dosing schedules such as single dose or delayed dose to minimise risk and maximise benefit of COVID-19 vaccination in children 5 to 11 years old.
Detailed description
BNT162b2 (Pfizer-BioNTech/Comirnaty®) vaccine is a mRNA vaccine that is (26/11/2021) approved for use in adults and adolescents (12 years old and above) under the Pandemic Special Access Route (PSAR) by the Health Sciences Authority (HSA), Singapore.1 Two doses of vaccine (30mcg) given 3 weeks apart was shown to be > 95% effective in the prevention of symptomatic COVID-19 infection.2 The latest phase 3 trial of the vaccine using a lower (10 mcg) two dose schedule (3 weeks apart) in children aged 5 to 11 year old was found to be > 90% effective.
Older age groups and those with comorbidities such as obesity, diabetes mellitus, etc are at highest risk of severe COVID-19 disease. Currently, recommendations for vaccination have been extended to adolescents in Singapore as well as many countries including the USA, Israel and Ireland, in view of the high rates of infection in this age group. On 29 October 2021, the FDA authorised the use of BNT162b2 Pfizer-BioNTech/Cominarty vaccine for emergency use in children 5 to 11 years old.4 Subsequently, the CDC recommended COVID-19 vaccination of children 5 to 11 years old in the USA using intramuscular 10mcg of BNT162b2 Pfizer-BioNTech/Comirnaty®) vaccine given 3 weeks apart.
A key concern regarding paediatric vaccination is a rare side effect of inflammation of the heart muscle (myocarditis) that has been observed after receipt of the second dose of BNT162b2,especially in younger age groups including adolescents and males. Centre for Disease Control (CDC), USA reported that there were 9.8 cases of myocarditis per million first doses given and this rose to 67 per million after the second dose. Most cases of myocarditis were benign and self-limiting but long-term impact remains uncertain.
There are possible alternatives to a standard two dose schedule given 21 days apart which may help reduce the risk of adverse events such as myocarditis. The extended interval between doses had been shown in the UK to result in improved immunogenicity in adults. The optimum timing of such a delayed dosing schedule remains unknown in children and identifying the best timing to help delay the need for boosters in children will be useful.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) | Other | Biological: BNT162b2 Pfizer-BioNTech/Comirnaty10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose. Two doses will be given at 2 months apart between doses. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children aged 5 to 11 years old
- No contraindications to mRNA COVID-19 Pfizer-BioNTech vaccines
- Had never received any COVID-19 vaccine before
- Never had previous COVID-19 infections
Key exclusion criteria (3 listed)
- Children outside the age group.
- Immunocompromised children.
- Participants with previous history of COVID-19 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 |
|---|---|---|
| BNT162b2 Pfizer-BioNTech/ComirnatyThe study will use 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose. Two doses will be given at 2 months apart between doses. | Biological | 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) |
Primary outcome
Percentage neutralizing antibody levels at 2m
Time frame: 2 Months
WHO International units/ml neutralizing antibody levels at 2m
Time frame: 2 Months
Geometric mean titres (GMT) neutralizing antibody levels at 2m
Time frame: 2 Months
3 secondary outcomes
Percentage neutralizing antibody levels at 6m and 9 to 12m
Time frame: 12 Months
WHO International units/ml neutralizing antibody levels at 6m and 9 to 12m
Time frame: 12 Months
GMT neutralizing antibody levels at 6m and 9 to 12m
Time frame: 12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 4 study testing BNT162b2 Pfizer-BioNTech/Comirnaty in people with Vaccine Reaction and COVID-19, run by KK Women's and Children's Hospital at 1 site in Singapore.
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 3 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 29 Apr 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 Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qing Lin Tan (+6563948696, tan.qing.lin@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage neutralizing antibody levels at 2m (time frame: 2 Months). The study lists 3 primary outcomes in all. 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 29 Apr 2022.