Comparison of the safety and immunogenicity of two-dose mRNA COVID-19 vaccine and inactivated followed by an mRNA vaccine in children aged 5 - 11 years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220212001

Enrollment

120

Registered

2022-02-12

Start date

2022-03-07

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Healthy children aged between 5-11 years 2. No history of COVID-19 infection COVID-19, children, BNT162b2, CoronaVac, mRNA, inactivated

Interventions

This group of healthy children will receive two doses of BNT162b2 intramuscularly at 8 weeks apart. Reactogenicity data will be collected for 7 days after vaccination. ,This group of healthy children

Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine,Active Comparator Biological/Vaccine

Homologous BNT162b2,Heterologous CoronaVac and BNT162b2,two-dose of BBIBP-CorV followed by BNT162b2

Eligibility

Sex/Gender

All

Age

5 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Healthy children between 5-11 years of age 2. No history of COVID-19 infection 3. Parents or guardians live in Bangkok and give informed consent to participate 4. Children between 7-11 years of age give informed assent to participate

Exclusion criteria

Exclusion criteria: 1. History of COVID-19 infection 2. Immunocompromised status 3. Bleeding tendency (contraindicated to blood drawing) 4. History of COVID-19 vaccine allergy or severe reaction from vaccine

Design outcomes

Primary

Measure	Time frame
Immunogenicity 28 days post two doses Anti-RBD IgG	—

Secondary

Measure	Time frame
Immunogenicity 28 days post tow doses Neutralizing antibody to SARS-CoV-2 omicron variant	—

Countries

Thailand

Contacts

Public ContactNasamon Wanlapakorn

Chulalongkorn University

nasamon.w@chula.ac.th022564000

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026