Determining Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children

NCT05329064 | Unknown Phase 4

• 1 other identifier: 2022/2003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Vaccine Reaction; COVID-19; Children, Only

Keywords

COVID-19; Vaccine; Children

Outcome Measures

Primary Outcomes (3)

• Percentage neutralizing antibody levels at 2m

  2 Months

• WHO International units/ml neutralizing antibody levels at 2m

  2 Months

• Geometric mean titres (GMT) neutralizing antibody levels at 2m

  2 Months

Secondary Outcomes (3)

• Percentage neutralizing antibody levels at 6m and 9 to 12m

  12 Months

• WHO International units/ml neutralizing antibody levels at 6m and 9 to 12m

  12 Months

• GMT neutralizing antibody levels at 6m and 9 to 12m

  12 Months

Study Arms (1)

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.

Biological: BNT162b2 Pfizer-BioNTech/Comirnaty

Interventions

BNT162b2 Pfizer-BioNTech/Comirnaty BIOLOGICAL

The study will use 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose. Two doses will be given at 2 months apart between doses.

10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®)

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children outside the age group.
• Immunocompromised children.
• Participants with previous history of COVID-19 infection.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Bukit Timah, 229899, Singapore

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Central Study Contacts

Qing Lin Tan

CONTACT

+6563948696; tan.qing.lin@kkh.com.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2022
• First Posted: April 14, 2022
• Study Start: March 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 29, 2022

Record last verified: 2022-03

Locations

SG (1)