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Human Vaccines & Immunotherapeutics Volume 19, 2023 - Issue 2
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Influenza

Immunogenicity and safety of the quadrivalent inactivated split-virion influenza vaccine in populations aged ≥ 3 years: A phase 3, randomized, double-blind, non-inferiority clinical trial

Jianmin Chena General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaORCID Iconhttps://orcid.org/0009-0003-0464-2035View further author information
ORCID Icon,
Feng Jiangb Institute of Immunization Program, Guizhou Center for Disease Control and Prevention, Guiyang, ChinaView further author information
,
Chenyan Zhaoc Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for Food and Drug Control (NIFDC), Beijing, ChinaView further author information
,
Jing Chaia General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaView further author information
,
Lanshu Lic Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for Food and Drug Control (NIFDC), Beijing, ChinaView further author information
,
Qinghu Guanb Institute of Immunization Program, Guizhou Center for Disease Control and Prevention, Guiyang, ChinaView further author information
,
Xiaoyu Lic Division of HIV/AIDS and Sex-Transmitted Virus Vaccines, National Institutes for Food and Drug Control (NIFDC), Beijing, ChinaView further author information
,
Feiyu Wanga General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaORCID Iconhttps://orcid.org/0009-0009-3901-6556View further author information
ORCID Icon,
Ansheng Lid Influenza Vaccine Production Workshop, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaView further author information
,
Hongxia Gaoe Quality Control Department, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaView further author information
,
Minghui Wanga General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaORCID Iconhttps://orcid.org/0009-0009-5538-341XView further author information
ORCID Icon,
Liandi Fud Influenza Vaccine Production Workshop, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaView further author information
,
Fei Niea General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaORCID Iconhttps://orcid.org/0009-0003-2682-6935View further author information
ORCID Icon,
Weijun Lingf Scientific Affairs Department, Simoon Record Beijing Co Ltd, Beijing, ChinaView further author information
,
Haobin Dengg Department of Bases Development, Simoon Record Beijing Co Ltd, Beijing, ChinaORCID Iconhttps://orcid.org/0009-0009-5109-8726View further author information
ORCID Icon &
Lei Zhoua General Manager Office, Dalian Aleph Biomedical Co Ltd, Dalian, ChinaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0009-0003-8402-0761View further author information
ORCID Icon show all
Article: 2245721 | Received 29 Mar 2023, Accepted 03 Aug 2023, Published online: 16 Aug 2023

Figures & data

Figure 1. Participant disposition.

Note: * Not caused by adverse events. Relocation: The participant left the study site. SS: Safety set including all participants who received at least one dose of the investigational vaccine. For participants who received the wrong vaccine number, a safety assessment was conducted in accordance with the “all participants as treated (ASaT)” principle to follow the actual vaccination group of the participants. FAS: Full analysis set including all participants who completed at least one dose of vaccination, collected pre-immunization blood samples, and had acceptable antibody titers. Participants with vaccination errors were subjected to immunogenicity evaluation by randomization grouping in accordance with the intention-to-treat principle. PPS: Per protocol set including all participants who complied with the inclusion criteria but did not meet the exclusion criteria, received vaccination as specified in the protocol after randomization, completed pre-immunization and post-immunization blood sampling for immunogenicity evaluation, and had acceptable antibody titers.
Figure 1. Participant disposition.

Table 1. Demographic data and baseline clinical characteristics of study participants (FAS).

Figure 2. Immunogenicity in all populations aged ≥3 years with pre-immunization antibody titers < 1:10 and pre-immunization antibody titers ≥ 1:10 (one-dose group) (FAS).

(a) SCRs of the various serotype antibodies between the investigational vaccine and control vaccine. (b) SCR differences of the various serotype antibodies between the investigational vaccine and control vaccine (comparison of non-inferiority). (c) GMTs of the various serotype antibodies between the investigational vaccine and control vaccine. (d) GMT ratios of the various serotype antibodies between the investigational and control vaccines (comparison of non-inferiority). (e) GMIs of the various serotype antibodies between the investigational and control vaccines. (f) SPRs of the various serotype antibodies between the investigational and control vaccines.
Figure 2. Immunogenicity in all populations aged ≥3 years with pre-immunization antibody titers < 1:10 and pre-immunization antibody titers ≥ 1:10 (one-dose group) (FAS).

Figure 3. Frequency and severity of post-immunization AEs in participants ≥3 years old.

Figure 3. Frequency and severity of post-immunization AEs in participants ≥3 years old.

Figure 4. Frequency and severity of post-immunization AEs in participants 3–8 years old.

Figure 4. Frequency and severity of post-immunization AEs in participants 3–8 years old.

Table A1. List of dropouts.

Table A2. Demographic data and baseline clinical characteristics of participants by age group (FAS).

Table A3. Comparison of non-inferiority in various age groups between the investigational and control vaccines (one-dose group) (FAS).

Table A4. Immunogenicity in participants in various age groups with pre-immunization antibody titers < 1:10 and pre-immunization antibody titers ≥ 1:10 (one-dose group) (FAS).

Table A5. Immunogenicity in participants 3–8 years old (PPS).

Table A6. Immunogenicity in participants 3–8 years old with and without vaccination history in the one-dose group (PPS).

Table A7. Total adverse events after different immunization procedures in participants 3–8 years old.

Data availability statement

The protocol is saved at Dalian Aleph Biomedical Co., Ltd. and is available from the corresponding authors if necessary.

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