A Phase 4 interventional study of Influenza Vaccine Group and Pneumococcal Vaccine Group in Influenza and Pneumonia, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Not yet recruiting. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 4, Interventional, and Prevention
This is a multicenter, open-label, blank-controlled clinical trial to evaluate the impact of influenza vaccination and pneumococcal vaccination on disease progression and medical burden in COPD patients aged 45-80 years, as well as the safety and immunogenicity of vaccination. COPD patients aged 45-80 years are recruited. On the basis of informed consent and voluntary participation, influenza and pneumococcal vaccination are carried out. At each site, towns/subdistricts will be randomly assigned as clusters to one of four groups in a 2:2:2:1 ratio: influenza vaccine group, pneumonia vaccine group, combined vaccination group, and blank control group. Follow-up lasts 12 months from informed consent.
For the immunogenicity subgroup, during the period from September 1, 2026 to October 31, 2026, the first 50 participants enrolled for influenza vaccination at each site (Dongtai City and Wujin District) are included in the influenza vaccine immunogenicity subgroup, and the first 50 participants enrolled for pneumococcal vaccination at each site are included in the pneumococcal vaccine immunogenicity subgroup, with the two subgroups serving as mutual controls. Blood samples (5ml each time) are collected before vaccination and at 1 month, 6 months, and 12 months after vaccination.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Biological: Influenza Vaccine Group
23-valent Pneumococcal Polysaccharide Vaccine, produced by Sinovac Biotech Co., Ltd. or Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Biological: Pneumococcal Vaccine Group
Both Trivalent Influenza Vaccine (Split Virion) and 23-valent Pneumococcal Polysaccharide Vaccine. One dose per vaccine, intramuscular.
Biological: Influenza Vaccine Group · Biological: Pneumococcal Vaccine Group
No vaccine. Participants receive usual care and follow-up.
Trivalent Influenza Vaccine (Split Virion), inactivated, produced by Sinovac Biotech Co., Ltd. One dose, intramuscular.
23-valent Pneumococcal Polysaccharide Vaccine, produced by Chengdu Institute of Biological Products Co., Ltd. One dose, intramuscular.
Number of COPD acute exacerbation events within 12 months after vaccination.
Number of COPD acute exacerbation events within 12 months after vaccination.
Time frame: 12 months after vaccination
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination.
Time frame: From baseline to 12 months after vaccination
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination.
Time frame: From baseline to 12 months after vaccination
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination.
Time frame: From baseline to 12 months after vaccination
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
Change in lung function (annual decline rate) from baseline to 12 months after vaccination.
Time frame: From baseline to 12 months after vaccination
Change in CAT score from baseline to 12 months after vaccination.
The COPD Assessment Test (CAT) is a questionnaire with total scores ranging from 0 to 40. Higher scores indicate worse health status. The outcome is the change from baseline to 12 months post-vaccination.
Time frame: From baseline to 12 months after vaccination
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
Incidence of serious adverse events (SAEs) within 12 months after vaccination.
Time frame: 12 months after vaccination
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Time frame: 1, 6, and 12 months after vaccination
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup).
Time frame: 1, 6, and 12 months after vaccination
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Number of COPD acute exacerbation events within 12 months after vaccination in participants aged 60 years and above.
Time frame: 12 months after vaccination
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.
Change in lung function (FEV₁ absolute value) from baseline to 12 months after vaccination in participants aged 60 years and above.
Time frame: From baseline to 12 months after vaccination
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination in participants aged 60 years and above.
Change in lung function (FEV₁/FVC) from baseline to 12 months after vaccination in participants aged 60 years and above.
Time frame: From baseline to 12 months after vaccination
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination in participants aged 60 years and above.
Change in lung function (FEV₁% predicted) from baseline to 12 months after vaccination in participants aged 60 years and above.
Time frame: From baseline to 12 months after vaccination
Change in lung function (annual decline rate) from baseline to 12 months after vaccination in participants aged 60 years and above.
Change in lung function (annual decline rate) from baseline to 12 months after vaccination in participants aged 60 years and above.
Time frame: From baseline to 12 months after vaccination
Change in CAT score from baseline to 12 months after vaccination in participants aged 60 years and above.
The COPD Assessment Test (CAT) is a questionnaire with total scores ranging from 0 to 40. Higher scores indicate worse health status. The outcome is the change from baseline to 12 months post-vaccination.
Time frame: From baseline to 12 months after vaccination
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
Incidence of serious adverse events (SAEs) within 12 months after vaccination in participants aged 60 years and above.
Time frame: 12 months after vaccination
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
Serum hemagglutinin antibody titers against influenza virus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
Time frame: 1, 6, and 12 months after vaccination
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
Serum neutralizing/killing antibody titers against pneumococcus at 1, 6, and 12 months after vaccination (immunogenicity subgroup) in participants aged 60 years and above.
Time frame: 1, 6, and 12 months after vaccination
Incidence of influenza within 12 months post-vaccination in COPD patients.
Incidence of influenza within 12 months post-vaccination in COPD patients.
Time frame: 12 months after vaccination
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
Incidence of pneumonia within 12 months post-vaccination in COPD patients.
Time frame: 12 months after vaccination
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
Of 101 non-industry phase 4 interventional studies under Influenza, Human, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 52. This study's planned 12 months is below that.
Counting every sponsor, half of 137 studies reached it within 14 months; a quarter within 3 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Province Centers for Disease Control and Prevention