A phase II/III, randomized, active-comparator, observer-blind, non-inferiority study to demonstrate the immunogenicity and safety of DS-5670a/b in children 5 through 11 years of age.

JRCT ID: jRCT2031220399

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: 10/05/2023
• Target sample size: 640
• Study type: Interventional
• Intervention(s): A dose of either DS-5670a/b or Comirnaty RTU IM will be intramuscularly administered twice in total to the deltoid muscle of the upper arm.

Outcome(s)

• Primary Outcome: GMT of blood neutralizing activity against SARS-CoV-2 (Omicron strain BA.5) and seroresponse rate at 4 weeks after the second study drug administration

Secondary Outcome

Efficacy
- Geometric mean fold rise (GMFR) of blood neutralizing activity against SARS-CoV-2 (Omicron strain BA.5) at 4 weeks after the second study drug administration
- GMT, seroresponse rate and GMFR of blood neutralizing activity against SARS-CoV-2(original strain) at 4 weeks after the second study drug administration
- Incidence of COVID-19 for 52 weeks after the second study drug administration

Safety
Solicited adverse events (injection site and systemic), Unsolicited adverse events, Serious adverse events, Laboratory values for 28 days after the second study drug administration

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: <= 11age old
• Gender: Both

Include criteria

1)Children aged 5 to 11 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