A Phase 4 interventional study of 23-valent pneumococcal polysaccharide vaccine and Quadrivalent split-virion influenza vaccine in Pneumococcal Polysaccharide Vaccine, Influenza Vaccines and Preoperative, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 4, Interventional, and Prevention
Postoperative pneumonia (POP) affects 4%-24% of lung cancer surgery patients, increasing mortality, stay, costs and worsening prognosis, especially in older patients. Perioperative immunosuppression and synergistic influenza/pneumococcal infection support perioperative vaccination, which may also induce trained immunity; thoracic surgery data are lacking.
This multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial will enroll \~1278 patients aged ≥50 undergoing anatomical lung resection for pulmonary nodules or lung cancer, randomized 1:1 to vaccination or no vaccination, with 180-day follow-up.
Randomization uses a computer-generated, site-stratified block sequence, concealed via central IWRS or sealed envelopes. An unblinded team handles screening, randomization and vaccination data; surgeons and assessors are blinded. No site may exceed 50% of enrollment.
Vaccination group receives 23-valent pneumococcal polysaccharide and quadrivalent influenza vaccines intramuscularly in separate arms 14-28 days preoperatively. Controls receive no vaccine/placebo, with surgery scheduled 14-28 days after randomization. Concomitant indicated treatments are permitted and recorded.
Primary endpoint is POP per modified CDC/NHSN criteria: new/progressive imaging infiltrate (excluding atelectasis, edema, embolism, tumor), plus ≥1 clinical sign (fever >38 °C, WBC ≤4000 or ≥12,000/mm³, or altered mental status if ≥70 years) and ≥2 respiratory signs. Findings on days 3-5 are excluded unless persistent/worsening. Microbiology is confirmatory, not required.
Background: Postoperative pneumonia (POP) is a common complication of lung cancer surgery, with reported incidences of 4% to 24%. It increases mortality, prolongs hospital stay, raises medical costs and worsens long-term prognosis; older patients are at particular risk of severe pneumonia and acute respiratory failure. Surgical stress causes transient perioperative immunosuppression, and influenza virus and Streptococcus pneumoniae act synergistically in causing disease. Observational data suggest that perioperative vaccination reduces postoperative pneumonia after major surgery, but thoracic surgery has rarely been studied. Beyond pathogen-specific antibodies, vaccination may also induce "trained immunity", reprogramming innate immune cells to respond more effectively to non-specific pathogens.
Design: Multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. Approximately 1278 patients aged 50 years or older scheduled for anatomical lung resection (segmentectomy, lobectomy, sleeve resection, etc.) for pulmonary nodules or lung cancer will be randomized 1:1 to the vaccination group or the no-vaccination group and followed until 180 days after surgery.
Randomization: Computer-generated block randomization sequence produced by an independent statistical team (SAS or R), stratified by site with equal allocation at each site. Allocation is concealed through a central interactive web response system (IWRS) or sealed numbered envelopes. An unblinded team, trained and bound by a confidentiality agreement, performs screening, randomization and collection of vaccination information only. The surgical team and the outcome assessors are blinded to group assignment. No single site may enroll more than 50% of the total sample.
Interventions: Vaccination group: 23-valent pneumococcal polysaccharide vaccine (0.5 mL) plus quadrivalent split-virion influenza vaccine (0.5 mL), administered intramuscularly in separate upper arms at a community health service center or designated vaccination site, completed 14 to 28 days before surgery. Control group: no vaccination and no placebo; surgery is likewise scheduled 14 to 28 days after randomization to balance timing, during which routine preoperative respiratory exercises are permitted. Clinically indicated concomitant treatment (e.g., prophylactic antibiotics, analgesics, nutritional support) is permitted; anti-infective drugs, immunomodulators and potent antitussives/sedatives are recorded.
Primary endpoint definition: Postoperative pulmonary infection is defined using modified US CDC/NHSN criteria and requires all three of: (1) imaging (required): new or progressive infiltrate, consolidation or ground-glass opacity on chest X-ray/CT, after excluding normal postoperative atelectasis, pulmonary edema, pulmonary embolism and tumor progression; (2) at least 1 clinical sign: fever greater than 38 degrees C without other identified cause, WBC 4000/mm3 or less or 12,000/mm3 or more, or altered mental status without other cause in patients aged 70 or older; (3) at least 2 respiratory signs: new purulent sputum/change in sputum character/increased secretions or suctioning; dyspnea, tachypnea (greater than 24/min) or new/worsening cough; rales or bronchial breath sounds; worsening gas exchange (PaO2/FiO2 240 mmHg or less, SpO2 decrease of 5% or more, increased oxygen or ventilator requirement). Findings within postoperative days 3 to 5 are not counted as infection unless persistent or worsening; CRP and procalcitonin trends support the diagnosis. Microbiological evidence confirms but is not required.
2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.
This study's planned enrollment of 1,278 is above the median of 240 across 1,894 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 165 studies on the registry; 67 are open to participants now.
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Exclusion Criteria:
23-valent pneumococcal polysaccharide vaccine (0.5 mL) plus quadrivalent split-virion influenza vaccine (0.5 mL), given intramuscularly in separate upper arms 14 to 28 days before surgery, followed by anatomical lung resection and routine perioperative care.
Biological: 23-valent pneumococcal polysaccharide vaccine · Biological: Quadrivalent split-virion influenza vaccine
No vaccine and no placebo. Surgery is scheduled 14 to 28 days after randomization (routine preoperative respiratory exercises permitted), followed by anatomical lung resection and routine perioperative care.
Single 0.5 mL intramuscular dose in one upper arm, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.
Single 0.5 mL intramuscular dose in the opposite upper arm from the pneumococcal vaccine, completed 14 to 28 days before surgery, at a community health service center or designated vaccination site.
Proportion of participants with postoperative pulmonary infection within 30 days after surgery
Pulmonary infection defined by modified US CDC/NHSN criteria (new or progressive pulmonary infiltrate on imaging, at least 1 clinical sign and at least 2 respiratory signs), confirmed by an independent Endpoint Adjudication Committee blinded to group assignment.
Time frame: From surgery to 30 days after surgery
Proportion of participants with postoperative pulmonary infection within 90 days after surgery
Same definition and blinded adjudication as the primary outcome.
Time frame: From surgery to 90 days after surgery
Proportion of participants with postoperative pulmonary infection within 180 days after surgery
Same definition and blinded adjudication as the primary outcome.
Time frame: From surgery to 180 days after surgery
Incidence of severe pneumonia
Severe pneumonia defined as 1 major criterion (invasive mechanical ventilation; septic shock requiring vasopressors) or at least 3 minor criteria (respiratory rate 30/min or more; PaO2/FiO2 250 or less; multilobar infiltrates; confusion/disorientation; BUN 20 mg/dL or more; WBC below 4000/mm3 due to infection; platelets below 100,000/mm3; core temperature below 36 degrees C; hypotension requiring aggressive fluid resuscitation).
Time frame: Within 30, 90 and 180 days after surgery
Incidence of respiratory failure
Type I: PaO2 below 60 mmHg with normal or low PaCO2 (50 mmHg or less). Type II: PaO2 below 60 mmHg with PaCO2 above 50 mmHg.
Time frame: Within 30, 90 and 180 days after surgery
Incidence of Streptococcus pneumoniae infection
Any of: S. pneumoniae isolated from sputum, bronchoalveolar lavage fluid or blood culture; positive urinary pneumococcal antigen; or a 4-fold or greater rise in serum pneumococcal antibody titer between acute and convalescent samples.
Time frame: Within 30, 90 and 180 days after surgery
Incidence of influenza virus infection
Any of: positive influenza RT-PCR on nasopharyngeal swab, sputum or bronchoalveolar lavage fluid; positive rapid antigen test; positive viral culture; or positive influenza-specific IgM or a 4-fold or greater rise in IgG titer.
Time frame: Within 30, 90 and 180 days after surgery
Postoperative length of hospital stay
Number of days from leaving the operating room to hospital discharge.
Time frame: From end of surgery to hospital discharge, assessed up to 180 days
Rate of postoperative ICU admission
Time frame: From surgery to hospital discharge, assessed up to 180 days
Length of ICU stay
Duration of ICU stay in hours.
Time frame: From surgery to hospital discharge, assessed up to 180 days
Rate of unplanned postoperative antibiotic use
Proportion of participants in whom antibiotics are restarted for suspected infection after discontinuation of postoperative prophylactic antibiotics.
Time frame: From surgery to 180 days after surgery
Duration of postoperative chest tube drainage
Number of days the chest tube remains in place after surgery.
Time frame: From surgery to chest tube removal, assessed up to 180 days
30-day unplanned readmission rate
Readmission due to fever, dyspnea or thoracic infection.
Time frame: Within 30 days after surgery
Total hospitalization costs
Total costs including drug, examination, surgical and material costs.
Time frame: From admission for surgery to 180 days after surgery
Antibiotic costs
Time frame: From admission for surgery to 180 days after surgery
Incidence of adverse events and serious adverse events
Including local and systemic vaccine reactions; graded according to NCI-CTCAE version 5.0.
Time frame: From randomization to 180 days after surgery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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 ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: 23-valent pneumococcal capsular polysaccharide vaccine
The First Affiliated Hospital of Guangzhou Medical University →