Pneumococcal InfectionsPhase 1PICTPCV13iNCT04100772

Phase I Clinical Trial of a Candidate PCV13 in Healthy People Aged 6 Weeks and Above

A Phase 1 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: 237 participants
Where: 1 siteChina
Study dates: 18 May 2020to 23 Aug 2022
Phase: Phase 1
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 I Clinical Trial to Preliminary 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
0.5mL,Intramuscular other name:PCV13i
13-Valent Pneumococcal Polysaccharide Conjugate VaccineBiological
0.5mL,Intramuscular other name:Prevnar

Study groups in NCT04100772
Study group	Role	What they receive
vaccine 1A	Experimental	Subjects received one dose of PCV13i at 18 to 49 years old Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 2A	Experimental	Subjects received one dose of PCV13i at 50 years old and above Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 3A	Experimental	Subjects received one dose of PCV13i at 6 to 17 years old Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 4A	Experimental	Subjects received one dose of PCV13i at 2 to 5 years old Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 5A	Experimental	Subjects received two doses of PCV13i at 7 months to 2 years old Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 6A	Experimental	Subjects received three doses of PCV13i at 3,4,5 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 7A	Experimental	Subjects received three doses of PCV13i at 2,4,6 months of age Receives: Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）
vaccine 7B	Active comparator	Subjects received three doses of PCV13 at 2,4,6 months of age 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 items of adverse reactions
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Measured: within 7 days post each vaccination
Safety items of SAE
Occurrence of SAE of each subject(Arm 1A-7B)
Measured: within 6 months post last vaccination
Safety items of Hematological examination
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
Measured: day 4 post vaccination
Safety items of Urine test
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
Measured: day 4 post vaccination
Safety items of Blood chemistry test
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
Measured: day 4 post vaccination
Safety items of pressure value
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
Measured: day 4 post vaccination
Safety items of heart rate
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
Measured: day 4 post vaccination
Safety items of adverse reactions
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Measured: within 30 days post each vaccination

Secondary outcomes (4)

immunogencity items of seropositivity rates by ELISA
Serotype-specific seropositivity rates of Immunoglobulin G concentrations above 0.35ug/ml in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Measured: day 30 post last vaccination
immunogencity items of GMC by ELISA
Serotype specific IgG GMC of each the pneumococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Measured: day 30 post last vaccination
immunogencity items of GMI by ELISA
Serotype-specific GMI value pneumococcfor each of the pneunococcal serotypes in subjects aged 2 and 3 months post last vaccination(Arm 6A-7B)
Measured: day 30 post last vaccination
immunogencity items of GMT
Serological response in terms of GMT for each of the pneumococcal serotypes tested by OPA in subjects aged 2 months post last vaccination(7A、7B)
Measured: day 30 post last vaccination

Timeline

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

18 May 202023 Aug 2022

First posted24 Sep 2019
Study start18 May 2020
Primary completion23 Jun 2021
Study completion23 Aug 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 237 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04100772
Sponsor's protocol ID: CS-CTP-PCV
Acronym: PICTPCV13i
Status last verified: Oct 2022
First submitted: 18 Sep 2019
Last updated: 31 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: In order to maintain the rights of the subject, do not open the IPD

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

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
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Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized,Blind, Positive-controlled Phase I Clinical Trial to Preliminary 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: NCT04100772
Acronym / sponsor ID: PICTPCV13i / CS-CTP-PCV
Conditions: Pneumococcal Infections, Streptococcal Infections, Bacterial Infections
Keywords: PCV13, 13 valent Pneumococcal conjugate vaccine, Pneumococcal Infections, Safety, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 237 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Collaborators: Henan Center for Disease Control and Prevention
Study start: 18 May 2020 (actual)
Primary completion: 23 Jun 2021 (actual)
Study completion: 23 Aug 2022 (actual)
First posted: 24 Sep 2019 (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: 8

Arm	Type	Receives
vaccine 1A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received one dose of PCV13i at 18 to 49 years old
vaccine 2A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received one dose of PCV13i at 50 years old and above
vaccine 3A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received one dose of PCV13i at 6 to 17 years old
vaccine 4A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received one dose of PCV13i at 2 to 5 years old
vaccine 5A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received two doses of PCV13i at 7 months to 2 years old
vaccine 6A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received three doses of PCV13i at 3,4,5 months of age
vaccine 7A	Experimental	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）Subjects received three doses of PCV13i at 2,4,6 months of age
vaccine 7B	Active comparator	Biological: 13-Valent Pneumococcal Polysaccharide Conjugate VaccineSubjects received three doses of PCV13 at 2,4,6 months of age

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）0.5mL,Intramuscular other name:PCV13i	Biological	vaccine 1A, vaccine 2A, vaccine 3A, vaccine 4A, vaccine 5A, vaccine 6A, vaccine 7A
13-Valent Pneumococcal Polysaccharide Conjugate Vaccine0.5mL,Intramuscular other name:Prevnar	Biological	vaccine 7B

Primary outcome

Safety items of adverse reactions
Time frame: within 7 days post each vaccination
Occurrence of adverse reactions of each subject(Arm 1A-7B)
Safety items of SAE
Time frame: within 6 months post last vaccination
Occurrence of SAE of each subject(Arm 1A-7B)
Safety items of Hematological examination
Time frame: day 4 post vaccination
Occurrence of abnormal changes of Hematological examination in subjects of 2 years old and above(Arm 1A-4A)
Safety items of Urine test
Time frame: day 4 post vaccination
Occurrence of abnormal changes of Urine test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of Blood chemistry test
Time frame: day 4 post vaccination
Occurrence of abnormal changes of Blood chemistry test in subjects of 2 years old and above(Arm 1A-4A)
Safety items of pressure value
Time frame: day 4 post vaccination
Occurrence of abnormal changes of pressure valus in subjects of 18 years old and above(Arm 1A-2A)
Safety items of heart rate
Time frame: day 4 post vaccination
Occurrence of abnormal changes of heart rate in subjects of 18 years old and above(Arm 1A-2A)
Safety items of adverse reactions
Time frame: within 30 days post each vaccination
Occurrence of adverse reactions of each subject(Arm 1A-7B)

4 secondary outcomes

immunogencity items of seropositivity rates by ELISA
Time frame: day 30 post last vaccination
immunogencity items of GMC by ELISA
Time frame: day 30 post last vaccination
immunogencity items of GMI by ELISA
Time frame: day 30 post last vaccination
immunogencity items of GMT
Time frame: day 30 post last 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 31 Oct 2022.
Individual participant dataSharing planned: No. In order to maintain the rights of the subject, do not open the IPD

Related trials for Pneumococcal Infections

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
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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.

Xia Shengli 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 31 Oct 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 items of adverse reactions (time frame: within 7 days post each vaccination). The study lists 8 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 NCT04100772.

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 31 Oct 2022.