A phase III, randomized, active-comparator, non-inferiority study to demonstrate the Immunogenicity and Safety of DS-5670a in children 12 through 17 years of age.

A phase III, randomized, active-comparator, non-inferiority study to demonstrate the Immunogenicity and Safety of DS-5670a (COVID-19 vaccine) in children 12 through 17 years of age.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220400

Enrollment

450

Registered

2022-10-20

Start date

2022-11-12

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)

Interventions

A intramuscular injection of DS-5670a or Comirnaty twice in total

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Children aged 12 to 17 years at the time of informed consent. 2)Subjects who have legal representative signed a written informed consent 3)Subjects who have no history of vaccination against SARS-CoV-2 at the time of consent. 4)Subjects who are willing and able to comply with all scheduled requirements including medical examinations, laboratory tests, and report any symptoms. (possibly filed by legal representative )

Exclusion criteria

Exclusion criteria: 1)Subjects who have a history of seizure or epilepsy due to vaccination. 2)Subjects who have a history of myocarditis or pericarditis 3))Subjects who have had a positive result of SARS-CoV-2 infection test or diagnosed as SARS-CoV-2 infection by medical attention within three months of consent 4)Subjects who have suggestive symptoms of SARS-CoV-2 infection (respiratory symptoms, headache, malaise, olfactory disturbance, taste disturbance, pharyngalgia etc.) at the time of consent. 5)Subjects who have a positive result of SARS-CoV-2 antigen test at the time of eligibility assessment. 6)Subjects who have a history of anaphylaxis or severe allergy to food, pharmaceuticals, cosmetics, vaccination, etc.

Design outcomes

Primary

Measure	Time frame
Geometric mean titer (GMT) and seroconversion rate of serum neutralizing activity against SARS-CoV-2 4 weeks after the second dose of the study drug (Day 57)	—

Secondary

Measure	Time frame
Efficacy - Geometric mean fold rise (GMFR) of serum neutralizing activity against SARS-CoV-2 4 weeks after the second dose of the study drug (Day 57) - The incidence of COVID-19 infection within 52 weeks from the administration of study drug (Day 393) Safety - Specified adverse events (injection site and systemic), Non-specified adverse events, Serious adverse events, Laboratory test values	—

Contacts

Public ContactContact for Clinical Trial Information

DAIICHI SANKYO Co.,Ltd.

dsclinicaltrial@daiichisankyo.co.jp+81-3-6225-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026