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.

JRCT ID: jRCT2031220400

Registered date:20/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease by Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)
• Date of first enrollment: 12/11/2022
• Target sample size: 450
• Study type: Interventional
• Intervention(s): A intramuscular injection of DS-5670a or Comirnaty twice in total

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 17age old
• Gender: Both

Include 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 )

Exclude 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.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare