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A Phase 2/3, Randomized, Observer-Blind, Active-Controlled Study to Compare the Immunogenicity of the fourth dose of S-268019 to the COMIRNATY intramuscular injection in Adults over 60 years of ages (COVID-19)

A Phase 2/3 Study of S-268019 in Adults over 60 years of ages(COVID-19)

198

The proportion of male participants was 66.7% in the S-268019-b group, and 68.1% in the COMIRNATY group. The median age (range) of the participants was 67.0 (60 to 84) years in the S-268019-b group, and 66.0 (60 to 86) years in the COMIRNATY group. The mean BMI (SD) was 23.67 (3.60) in the S 268019 b group, and 23.75 (4.11) in the COMIRNATY group. There were no substantial differences in the demographic and baseline characteristics of the Immunogenicity Subset between the study intervention groups.

A total of 198 participants (99 in the S-268019-b group, 99 in the COMIRNATY group) were randomized and received the study intervention. Immunogenicity Subset consisted of 190 participants (96 in the S-268019-b group, and 94 in the COMIRNATY group).

No treatment-related deaths or SAEs were reported. A total of 105 solicited systemic AEs were reported in 50.5% (50 of 99) in the S-268019-b group, and 136 solicited systemic AEs were reported in 58.6% (58 of 99) in the COMIRNATY group (hereinafter in the same order). The common solicited systemic AEs were myalgia (39.4%, 40.4%), fatigue (25.3%, 33.3%), headache (18.2%, 25.3%), arthralgia (9.1%, 14.1%), and nausea/vomiting (8.1%, 11.1%). A total of 117 solicited local AEs were reported in 76.8% (76 of 99) in the S-268019-b group, and 117 solicited local AEs were reported in 82.8% (82 of 99) in the COMIRNATY group. The most common solicited local AE was pain (76.8% in the S-268019-b group and 80.8% in the COMIRNATY group).

The ANCOVA-estimated GMTR (95% CI) of SARS-CoV-2 neutralizing antibody on Day 29 (S-268019-b/COMIRNATY) was 0.65 (0.50, 0.83) and the difference in the seroresponse rate (95% CI) of SARS-CoV-2 neutralizing antibody titer on Day 29 (S-268019-b minus COMIRNATY) was -30.1% (-44.5%, -15.7%). Thus, the lower limit of the 95% CI for the GMTR was lower than 0.67 (1 sided p = 0.6145), and that for the difference in the seroresponse rate was lower than -10% (1 sided p = 0.9970), and, therefore, noninferiority of S-268019-b compared to COMIRNATY was not demonstrated. However, although the SARS-CoV-2 neutralizing antibody titers were lower in the S-268019-b group than in the COMIRNATY group, the SARS-CoV-2 neutralizing antibody titers in the S-268019-b group clearly increased from baseline. The GMT (95% CI) of the SARS-CoV-2 neutralizing antibody on Day 29 was 58.94 (48.51, 71.59) compared to 24.66 (20.05, 30.33) at baseline in the S-268019-b group, and 91.90 (78.53, 107.54) compared to 24.41 (19.97, 29.82) at baseline in the COMIRNATY group.

Noninferiority of S-268019-b compared to COMIRNATY was not demonstrated, but the SARS-CoV-2 neutralizing antibody titers in the S-268019-b group clearly increased from baseline with in participants aged 60 years or older who had completed vaccination with 3 injections of COMIRNATY >= 5 months and <= 8 months prior to the first administration of study intervention and received S-268019-b or COMIRNATY as fourth administration. No significant safety issues related to S-268019-b were observed.

June. 24, 2025

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031220224

Nagata Tsutae

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Complete

July. 25, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

prevention purpose

Participant aged 60 or over 60 years, at the time of signing the informed consent form (ICF).
Participants with at least 5 months and not greater than 8 months after completion of the third vaccination with an approved SARS-CoV-2 vaccine, COMIRNATY.
Male and female
Capable of giving signed ICF from participant, as stated in the protocol which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Tested positive SARS-CoV-2 infection (as determined by SARS-CoV-2 antigen test) at Screening.
Determined in the interview prior to the study intervention to have a history of SARS-CoV-2 infection.
Current history of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation.
Immunosuppressed (immunocompromised, having acquired immunodeficiency syndrome [AIDS], having received steroids and having received systemic immunosuppressants within 6 months prior to the first dose of study intervention, being treated for malignant tumors, being on other immunosuppressive therapy).
Individuals considered to have hypersensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study (except for pollinosis and atopic dermatitis).
Participant has a contraindication to intramuscular(IM) injections or blood draws.

Both

Prevention of COVID-19

S-268019 (intramuscular injection) or COMIRNATY intramauscular injection

SARS-CoV-2 neutralizing antibody (NAb) titer at 28 days following the fourth vaccination
The incidence of adverse events (AEs), adverse reactions, serious AEs (SAEs), solicited AEs, medically-attended AEs (MAAEs), or AEs of special interest (AESIs), vital signs

+81-3-6665-0572

July. 15, 2022

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