Pneumococcal InfectionsPhase 3NCT04841369

Phase III Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above (PICTPCV13i)

A Phase 3 study testing 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） and 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine in people with Pneumococcal Infections and Streptococcal Infections, run by CanSino Biologics Inc. 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

Who is it for?: Ages 6 weeks and olderHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
What is being tested?: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） and 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,420 participants
Where: 1 siteChina
Study dates: 13 Apr 2021to 20 Sep 2022
Phase: Phase 3
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 6 weeks and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
Willing to provide proof of identity;
Without vaccination history of pneumococcal vaccine;
None-pregnancy or do not plan to pregnancy recently;;
Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;
Volunteers of 8-17 years old and their guardians who willing sign informed consent;
Able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below;
Able and willing comply with the requirements of the protocol

Who cannot join

Volunteers whose axillary body temperature was >37.0# before vaccination
Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
Volunteers who has a history of epilepsy, convulsions or psychosis;
Allergic person;
Any prior administration of blood products in last 3 month;
Any prior administration of other research medicines in last 1 month;

Show all 11Show fewer

Plans to participate in or is participating in any other drug clinical study;
Any prior administration of attenuated live vaccine in last 14 days;
Any prior administration of subunit or inactivated vaccines in last 7 days;
Had fever before vaccination, Volunteers with temperature >37.0°C on axillary setting;
According to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

Neihuang Center for Disease Control and Prevention
Anyang, Henan, 450016

Other trials in China

About this study

Official title: A Randomized,Blind, Positive-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above

Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.Since the licensure of PCV7 and PCV13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in Western countries.This is a single center,blind, randomized, positive-controlled clinical trial.The purpose of this study is to preliminary evaluate the safety of PCV13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of PCV13i vaccine at age of 2 and 3 months,compared to PCV13.

Conditions: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
Being tested: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）, 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
Keywords: PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity
Medical subject headings: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections

What participants receive

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

13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Biological
Also called PCV13i
0.5mL,Intramuscular
13-Valent Pneumococcal Polysaccharide Conjugate VaccineBiological
Also called Prevnar
0.5mL,Intramuscular

Study groups in NCT04841369
Study group	Role	What they receive
1A	Experimental	Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old) Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
1B	Active comparator	Subjects received four doses of PCV13 at 2 months of age (At least 6 weeks old) Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
2A	Experimental	Subjects received four doses of PCV13i at 3 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
3A	Experimental	Subject received three doses of PCV13i at 7 to 11 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
3B	Active comparator	Subject received three doses of PCV13 at 7 to 11 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
4A	Experimental	Subjects received two doses of PCV13i at 12 to 23 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
4B	Active comparator	Subjects received two doses of PCV13 at 12 to 23 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine
5A	Active comparator	Subjects received one dose of PCV13i at 2 to 5 years old. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
5B	Active comparator	Subjects received one dose of PCV13 at 2 to 5 years old. Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine

What is being measured

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

Safety of PCV13i in preventing pneumococcal infections
Occurance of adverse reactions in all subjects
Measured: Within 7 days post each vaccination
Safety of PCV13i in preventing pneumococcal infections
Occurance of adverse reactions in all subjects
Measured: Within 30 days post each vaccination
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Measured: 30 days post three doses
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Measured: 30 days post three doses
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Measured: 30 days post last dose of vaccination
Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Measured: 30 days post vaccination

Secondary outcomes (9)

Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Measured: 30 days post three doses
Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Measured: 30 days post three doses
Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Occurance of SAE in subjects of this age group
Measured: 6 months post one to three doses of vaccination
Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Measured: 30 days post two doses
Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
GMT of serotype-specific OPA antibody with the titer of ≥1:8 ratio
Measured: 30 days post last dose of vaccination
Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Measured: 30 days post two doses
Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Serotype-specific Immunoglobulin G with a concentration of ≥1.0μg/ml
Measured: 30 days post last dose of vaccination
Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)
Occurance of SAE in subjects of this age group
Measured: 6 months post two doses
Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Occurance of SAE in subjects of this age group
Measured: 6 months post last dose of vaccination

Timeline

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

13 Apr 202120 Sep 2022

First posted12 Apr 2021
Study start13 Apr 2021
Primary completion30 Mar 2022
Study completion20 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 3,420 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04841369
Sponsor's protocol ID: CS-CTP-PCV-III
Status last verified: Oct 2022
First submitted: 8 Apr 2021
Last updated: 2 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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?

See locations

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Active, not recruitingPhase 3
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All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Blind, Positive-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogencity of 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT） in Healthy People Aged 6 Weeks and Above
ClinicalTrials.gov ID: NCT04841369
Acronym / sponsor ID: CS-CTP-PCV-III
Conditions: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
Keywords: PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,420 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Collaborators: Henan Center for Disease Control and Prevention
Study start: 13 Apr 2021 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 20 Sep 2022 (actual)
First posted: 12 Apr 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
1A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received four doses of PCV13i at 2 months of age (At least 6 weeks old)
1B	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received four doses of PCV13 at 2 months of age (At least 6 weeks old)
2A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received four doses of PCV13i at 3 months of age
3A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subject received three doses of PCV13i at 7 to 11 months of age
3B	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubject received three doses of PCV13 at 7 to 11 months of age
4A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received two doses of PCV13i at 12 to 23 months of age
4B	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received two doses of PCV13 at 12 to 23 months of age
5A	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received one dose of PCV13i at 2 to 5 years old.
5B	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received one dose of PCV13 at 2 to 5 years old.

Who may qualify

Ages: 6 weeks and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above;
Willing to provide proof of identity;
Without vaccination history of pneumococcal vaccine;
None-pregnancy or do not plan to pregnancy recently;;
Volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent;

Key exclusion criteria (11 listed)

Volunteers whose axillary body temperature was >37.0# before vaccination
Volunteers who suffered from Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
Volunteers who has a history of epilepsy, convulsions or psychosis;
Allergic person;
Any prior administration of blood products in last 3 month;

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
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Also: PCV13i0.5mL,Intramuscular	Biological	1A, 2A, 3A, 4A, 5A
13-Valent Pneumococcal Polysaccharide Conjugate VaccineAlso: Prevnar0.5mL,Intramuscular	Biological	1B, 3B, 4B, 5B

Primary outcome

Safety of PCV13i in preventing pneumococcal infections
Time frame: Within 7 days post each vaccination
Occurance of adverse reactions in all subjects
Safety of PCV13i in preventing pneumococcal infections
Time frame: Within 30 days post each vaccination
Occurance of adverse reactions in all subjects
Immunogenicity of PCV13i in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 7 to 11 months old (Arm 4A-4B)
Time frame: 30 days post three doses
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of 12 months to 5 years old (Arm 5A, 5B, 6A, 6B)
Time frame: 30 days post last dose of vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml
Immunogenicity of PCV13i in subjects of age 50 years old and above (Arm 6A, 6B, 7A, 7B)
Time frame: 30 days post vaccination
Serotype-specific seropositivity rates of Immunoglobulin G GMC concentrations above 0.35ug/ml

9 secondary outcomes

Immuogenicity in terms of GMT in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time frame: 30 days post three doses
Immunogenicity in terms of IgG concentration in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time frame: 30 days post three doses
Safety of PCV13i in terms of in subjects of 2 months (at least 6 weeks) old (Arm 1A-1B)
Time frame: 6 months post one to three doses of vaccination
Immuogenicity in terms of GMT in subjects of 7 to 11 months old (Arm 3A-3B)
Time frame: 30 days post two doses
Immuogenicity in terms of GMT in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time frame: 30 days post last dose of vaccination
Immunogenicity in terms of IgG concentration in subjects of 7 to 11 months old (Arm 3A-3B)
Time frame: 30 days post two doses
Immunogenicity in terms of IgG concentration in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time frame: 30 days post last dose of vaccination
Safety of PCV13i in terms of SAE in subjects of 7 to 11 months old (Arm 3A-3B)
Time frame: 6 months post two doses
Safety of PCV13i in terms of SAE in subjects of 12 months to 5 years old (Arm 4A, 4B, 5A, 5B)
Time frame: 6 months post last dose of 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 2 Apr 2024.

Related trials for Pneumococcal Infections

Active, not recruitingPhase 2
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Active, not recruitingObservational study
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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.

Shengli Xia principal investigator

Henan Province 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?

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 8 inclusion and 11 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 2 Apr 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Safety of PCV13i in preventing pneumococcal infections (time frame: Within 7 days post each vaccination). The study lists 6 primary outcomes in all. 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 NCT04841369.

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 2 Apr 2024.