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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06970756




Registration number
NCT06970756
Ethics application status
Date submitted
6/05/2025
Date registered
14/05/2025
Date last updated
18/05/2025

Titles & IDs
Public title
A Phase I Clinical Study to Evaluate the Safety of PCV26 in Individuals =60
Scientific title
A Phase I, Randomized, Double-blind, Parallel-controlled Clinical Study to Evaluate the Safety of a 26-valent Pneumococcal Conjugate Vaccine in Individuals Aged 60 and Above
Secondary ID [1] 0 0
2024170A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal Diseases 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 26-valent Pneumococcal Conjugate Vaccine
Treatment: Other - 13-valent Pneumococcal Conjugate Vaccine

Experimental: Vaccine group - 30 subjects aged =60 are enrolled in this group.

Active comparator: Active control group - 30 subjects aged = 60 years are enrolled in this group.


Treatment: Other: 26-valent Pneumococcal Conjugate Vaccine
Subjects were treated with a single intramuscular injection of 26-valent Pneumococcal Conjugate Vaccine.

Treatment: Other: 13-valent Pneumococcal Conjugate Vaccine
Subjects were treated with a single intramuscular injection of 13-valent Pneumococcal Conjugate Vaccine.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Solicited AEs within 0-7 days after vaccination
Timepoint [1] 0 0
Within 0-7 days after vaccination.
Primary outcome [2] 0 0
Solicited systemic AEs within 0-7 days after vaccination
Timepoint [2] 0 0
Within 0-7 days after vaccination.
Secondary outcome [1] 0 0
Unsolicited AEs within 0-28 days after vaccination
Timepoint [1] 0 0
Within 0-28 days after vaccination.
Secondary outcome [2] 0 0
SAEs and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination
Timepoint [2] 0 0
Within 0-6 months after vaccination.
Secondary outcome [3] 0 0
Laboratory testing clinically abnormalities on the 7th day after vaccination
Timepoint [3] 0 0
On the 7th day after vaccination

Eligibility
Key inclusion criteria
* Aged 60 years or older at the time of enrollment.
* Evidence of a personally signed and dated ICF indicating that the participant has been informed of all pertinent aspects of the study.
* Able to comply with the protocol, and capable of using a thermometer, a ruler, and fill out the diary card and contact card as required.
* Negative pregnancy test (urine) for female participants of childbearing potential. Male and non-pregnant, non-lactating females must also meet one of the following criteria: a). Female participant of nonchildbearing potential; male participant not able to father children; b). Agrees to consistently practice contraception until at least 28 days after vaccination by one of the following methods: condoms, male or female, with or without spermicide; diaphragm or cervical cap with spermicide; intrauterine device; contraceptive pills or patch; Norplant, Depo-Provera, or other FDA approved contraceptive method; or a female participant with a male partner who has previously undergone a vasectomy.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Current febrile illness (oral temperature =100.4°F [=38.0°C]) within 48 hours before vaccine administration.
* History of an infectious disease caused by Streptococcus pneumoniae confirmed by any modality of diagnosis within the last 3 years.
* History of any pneumococcal vaccination within the last 3 years.
* History of severe allergic reactions to any drug or vaccine, especially to any component of pneumococcal vaccines (including Pneumovax, any other tetanus toxoid-containing vaccine, or 13-valent pneumococcal conjugate vaccine), such as respiratory distress, angioedema, anaphylactic shock, allergic purpura, or thrombocytopenic purpura.
* History of any serious chronic disorder including respiratory diseases (eg., severe chronic obstructive pulmonary disease requiring supplemental oxygen, severe asthma), chronic hepatitis, chronic kidney disease (eg., end-stage renal disease with or without dialysis), clinically unstable cardiac diseases or cardiovascular diseases (eg., untreated or resistant hypertension [repeated office SBP >150 mmHg and/or DBP >95 mmHg], chronic cardiac insufficiency, coronary atherosclerotic heart disease), or clinically significant forms of drug or alcohol abuse or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
* Participants with known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
* History of thrombocytopenia, any coagulation disorder, receiving anticoagulant therapy, or any condition contraindicating administration of intramuscular injections.
* History of asplenia, splenectomy, or functional asplenia for any reason.
* Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt within 28 days of vaccination. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before vaccination. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
* Participants who has an acute illness or exacerbation of chronic illness =3 days before enrollment, or use of antipyretics, analgesics, and antihistamines (eg, acetaminophen, ibuprofen, aspirin) within this timeframe.
* Participants who have received any non-live vaccine =7 days before receipt of study vaccine; is scheduled to receive any non-live vaccine within 7 days (=7 days) following receipt of the study vaccine; has received any live vaccine =14 days before receipt of the study vaccine; or is scheduled to receive any live vaccine within 7 days (=7 days) following receipt of the study vaccine.
* Participation in other studies involving study drug(s), study vaccines, or study devices within 28 days prior to study enrollment and/or during study participation. Participation in purely observational studies is acceptable.
* Any = Grade 2 laboratory abnormality or any lab abnormality that, in the opinion of the investigator, renders the participant unsuitable for enrollment.
* Planning to relocate before the end of the study or planning to be away from the local area for an extended period during the scheduled study visits.
* Any condition that, in the opinion of the investigator, may interfere with the assessment of the study objectives.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
27/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/07/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Emeritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
3124 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lin Du
Address 0 0
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wenjian Fang
Address 0 0
Country 0 0
Phone 0 0
+86-18611630252
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06970756