ClinicalTrials.gg
RecruitingNCT07933458Updated Nov 12, 2026

A Study to Evaluate the Safety of Subunit Influenza Vaccine in People Aged 6 Months and Older

An observational study in Influenza, sponsored by Ab&B Bio-tech Co., Ltd.JS. Recruiting at 1 site in China. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Ab&B Bio-tech Co., Ltd.JS · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
7,000
Ages
6 Months and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 173 studies in Influenza, Human with a site in China — 30 open to participants now, 37 under way, 10 of them phase 3. Influenza, Human · China.

Planned enrollment
4th of 14
7,000 · median 230
Started
2026
with 14 others
Observational
14 of 173
5 open now
Primary completion
2027-03
later than 26 of 36 live
Registered
173rd of 173
by date
Lead sponsor
7 of 173
Ab&B Bio-tech Co., Ltd.JS

Among the 173 studies in Influenza, Human with a site in China, this one is the 4th largest by planned enrollment of the 14 observational ones that give a count, is one of 15 that started in 2026, is one of 14 observational ones, reaches primary completion later than 26 of the 36 other live ones, and was the 173rd registered.

Influenza, Human

2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.

Browse Influenza, Human studies →

Open to participants now

30 of the 173 studies in Influenza, Human with a site in China are open now. Recruiting first, the newest first:

24 more — sign in →

All 30 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 120 Influenza, Human studies recruiting now, 64 (53%) set no upper age limit and 46 (38%) stop at 75 or younger; 33 take children under 18; 66 take healthy volunteers.

This study: 6 Months and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 173 studies in Influenza, Human with a site in China, or all of them as a file.
02

Study summary

This is a post-marketing, prospective observational study to evaluate the safety of a subunit influenza vaccine and the factors influencing influenza vaccination in individuals aged 6 months and older. A total of 7,000 vaccinated participants will be divided into Subgroup A (1,000 participants, active surveillance) and Subgroup B (6,000 participants, passive surveillance), and monitored for adverse events and serious adverse events within 28 days after vaccination. Participants in Subgroup A will additionally complete an electronic questionnaire on their knowledge of influenza and factors influencing their vaccination decisions.

Read the detailed description

Study Objectives The primary objectives of this study are: (1) to evaluate the safety of the subunit influenza vaccine in individuals aged 6 months and older after vaccination, in order to assess the occurrence of adverse reactions; and (2) to investigate vaccinated individuals' knowledge of influenza and influenza vaccine, and the factors influencing their vaccination decisions.Study Design This is a post-marketing, prospective, open-label, single-arm observational study. Participants who have already received the subunit influenza vaccine at the study site will be enrolled and divided into two subgroups according to the surveillance mode: Subgroup A (1,000 participants) under active surveillance, and Subgroup B (6,000 participants) under passive surveillance. All participants will be observed for 30 minutes after vaccination and monitored for adverse events (AEs) and serious adverse events (SAEs) within 28 days after vaccination.Study Population Individuals aged 6 months and older who have received the subunit influenza vaccine at the study site and are able to comply with the study requirements. Participants with allergy to any vaccine component (including excipients, formaldehyde, or Triton N-101), acute illness, severe chronic disease, acute exacerbation of chronic disease, fever, uncontrolled epilepsy, other progressive neurological diseases, a history of Guillain-Barré syndrome, or a history of severe adverse reactions to previous influenza vaccination will be excluded.Safety Monitoring All participants will remain under observation for 30 minutes immediately after vaccination. The occurrence of AEs and SAEs within 28 days post-vaccination will be collected and recorded, including solicited local reactions (pain, swelling, erythema, pruritus, induration, ecchymosis) and systemic events (fever, cough, headache, rhinorrhea, fatigue, myalgia, arthralgia, gastrointestinal symptoms, rash, etc.). Subgroup A participants will receive a telephone follow-up on Day 28, while Subgroup B participants will self-report AEs to investigators during the same period. Any SAE will be reported in accordance with applicable regulations.Influencing Factor Survey Participants in Subgroup A will complete an electronic questionnaire during the post-vaccination observation period (by themselves if aged 18 years or older, or by their guardians if under 18), collecting demographic information, medical and vaccination history, and their knowledge of influenza and influenza vaccine, as well as the factors influencing their vaccination decisions.

03

Conditions studied

  • Influenza

Browse trials for

Keywords

  • Influenza, Human
  • Safety
  • Vaccination influencing factors
  • Subunit Influenza Vaccine
04

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy individuals aged 6 months and older who have received the subunit influenza vaccine at the study site and meet the eligibility criteria.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 6 months and older;
  2. Have received the subunit influenza vaccine at the study site;
  3. Able to comply with the requirements of the study protocol

Exclusion criteria

Exclusion Criteria:

  1. Allergy to any component of the vaccine, including , formaldehyde, or the splitting agent Triton N-101;
  2. Acute illness, severe chronic disease, acute exacerbation of chronic disease, or fever;
  3. Uncontrolled epilepsy or other progressive neurological diseases, or a history of Guillain-Barré syndrome;
  4. History of severe adverse reactions following previous influenza vaccination;
  5. Any other condition deemed by the investigator to be unsuitable for enrollment.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
7,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group A

    Active Surveillance Group

    Biological: Group A

  • Group B

    Passive Surveillance Group

    Biological: Group B

Interventions

  • BiologicalGroup A

    Participants will receive one dose of Subunit Influenza Vaccine

  • BiologicalGroup B

    Participants will receive one dose of Subunit Influenza Vaccine

06

What researchers measure

Primary outcomes

  1. Occurrence of AEs and ADRs

    Adverse events and adverse drug reactions occurring within 28 days of vaccination will be recorded, including solicited local and systemic reactions.

    Time frame: Within 28 days post-vaccination

  2. Occurrence of SAEs

    Serious adverse events occurring within 28 days of vaccination will be recorded.

    Time frame: Within 28 days post-vaccination

07

Study locations

1 of 1 sites recruiting
  • Ganzhou Center for Disease Control and Prevention (Ganzhou Health Comprehensive Supervision and Law Enforcement Bureau)
    Ganzhou, Jiangxi, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.

Of 98 non-industry observational studies under Influenza, Human, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 92. This study's planned 6 months is below that.

Counting every sponsor, half of 135 studies reached it within 23 months; a quarter within 7 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartActual
Sep 4, 2026
Primary completionEst.
Mar 31, 2027
CompletionEst.
Sep 30, 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07933458
Lead sponsor
Ab&B Bio-tech Co., Ltd.JS
Collaborators
Ganzhou Center for Disease Control and Prevention (Ganzhou Health Comprehensive Supervision and Law Enforcement Bureau)
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Sep 4, 2026
Primary completion
Mar 31, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

XiaoRong Zhong
Contact
gzcdcjmk@126.com
86-18907078306

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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