VaccinationPhase 4NCT04700618

A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old

A Phase 4 study testing 23-valent pneumococcal polysaccharide vaccine in people with Vaccination, run by China National Biotec Group Company Limited at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai. Read more about this study

Who is it for?: Ages 60 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Vaccination
What is being tested?: 23-valent pneumococcal polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 330 participants
Where: 1 siteChina
Study dates: 21 Mar 2021to 13 Feb 2022
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The age was 60-70 years old on the day of enrollment;
The subjects have signed the informed consent and signed the date;
The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

Who cannot join

With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Shanghai municipal center for disease control and prevention
Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.

Read the detailed description

Antibody double growth rate in 28-40 days after immunization;
Antibody GMC level in 28-40days after immunization;
Incidence of adverse reactions in 0-30days.

Conditions: Vaccination
Being tested: 23-valent pneumococcal polysaccharide vaccine
Keywords: safety, immunogenicity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

23-valent pneumococcal polysaccharide vaccineBiological
The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.

Study groups in NCT04700618
Study group	Role	What they receive
Study group	Experimental	The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years. Receives: Biological: 23-valent pneumococcal polysaccharide vaccine
Control group	Placebo comparator	The control group had never been vaccinated with any pneumococcal vaccine. Receives: Biological: 23-valent pneumococcal polysaccharide vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody doubling rate
The difference of serum antibody double growth level between the two groups was compared.
Measured: The blood collection time was 28-40 days after vaccination.

Secondary outcomes (2)

Antibody GMC level
The difference of serum antibody GMC level between the two groups was compared.
Measured: The blood collection time was 28-40 days after vaccination.
Incidence of adverse reactions
Adverse reactions were collected during the observation period.
Measured: Within 30 days after vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Mar 202113 Feb 2022

First posted8 Jan 2021
Study start21 Mar 2021
Primary completion22 Aug 2021
Study completion13 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for VaccinationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Study group is PPV23 revaccination and control group PPV23-vaccination.
Masking: None (open label)
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04700618
Sponsor's protocol ID: PPV23-2021-2
Status last verified: Feb 2022
First submitted: 6 Jan 2021
Last updated: 16 Feb 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai
ClinicalTrials.gov ID: NCT04700618
Acronym / sponsor ID: PPV23-2021-2
Conditions: Vaccination
Keywords: safety, immunogenicity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
Collaborators: Shanghai Municipal Center for Disease Control and Prevention
Study start: 21 Mar 2021 (actual)
Primary completion: 22 Aug 2021 (actual)
Study completion: 13 Feb 2022 (actual)
First posted: 8 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.

Detailed description

Antibody double growth rate in 28-40 days after immunization;
Antibody GMC level in 28-40days after immunization;
Incidence of adverse reactions in 0-30days.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Study group is PPV23 revaccination and control group PPV23-vaccination.

Arm	Type	Receives
Study group	Experimental	Biological: 23-valent pneumococcal polysaccharide vaccineThe subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years.
Control group	Placebo comparator	Biological: 23-valent pneumococcal polysaccharide vaccineThe control group had never been vaccinated with any pneumococcal vaccine.

Who may qualify

Ages: 60 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

The age was 60-70 years old on the day of enrollment;
The subjects have signed the informed consent and signed the date;
The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.

Key exclusion criteria (3 listed)

With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
23-valent pneumococcal polysaccharide vaccineThe study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.	Biological	Control group, Study group

Primary outcome

Antibody doubling rate
Time frame: The blood collection time was 28-40 days after vaccination.
The difference of serum antibody double growth level between the two groups was compared.

2 secondary outcomes

Antibody GMC level
Time frame: The blood collection time was 28-40 days after vaccination.
Incidence of adverse reactions
Time frame: Within 30 days after vaccination.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiang Guo study chair

Shanghai Municipal Center for Disease Control and Prevention

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 23-valent pneumococcal polysaccharide vaccine in people with Vaccination, run by China National Biotec Group Company Limited at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody doubling rate (time frame: The blood collection time was 28-40 days after vaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04700618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.