Streptococcus Pneumoniae InfectionsPhase 3NCT06817187

Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine

A Phase 3 study testing 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) in people with Streptococcus Pneumoniae Infections, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd 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

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population Read more about this study

Who is it for?: Ages 3 to 3 monthsHealthy volunteers can take part
Conditions the study is for: Streptococcus Pneumoniae Infections
What is being tested?: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,110 participants
Where: 1 siteChina
Study dates: 16 Sep 2021to 13 Mar 2024
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 3 to 3 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg;
The legal guardian provides informed consent and signs the informed consent form;
The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.

Who cannot join

A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation;
Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine;
History or family history of seizures, epilepsy, encephalopathy, and mental illness;
Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage;
A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection;
Injecting human normal immunoglobulin after birth;

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Known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (HIV) infection, etc;
Having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism);
Currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors;
Severe asthma;
Systemic rash, skin ringworm, skin suppuration or blisters;
Currently or planning to participate in clinical trials of other drugs in the near future; Researchers believe that any situation that may affect the evaluation of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, 050021

Other trials in China

About this study

Official title: A Single Center, Randomized, Open Label, Controlled Clinical Study to Evaluate the Mutual Influence of Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed)

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population

Conditions: Streptococcus Pneumoniae Infections
Being tested: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed), Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
Keywords: 15-valent pneumococcal conjugate vaccine, Diphtheria, Tetanus, Pertussis Vaccine
Medical subject headings: Pneumococcal Infections, Diphtheria, Tetanus

What participants receive

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

15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Biological
Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Biological
Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).
Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Biological
Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).

Study groups in NCT06817187
Study group	Role	What they receive
P+DTP group	Experimental	370 infants aged 3 months were enrolled in this group. Receives: Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
P-DTP group	Experimental	370 infants aged 3 months were enrolled in this group. Receives: Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)
DTP group	Active comparator	370 infants aged 3 months were enrolled in this group. Receives: Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)

What is being measured

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

Antibody positive conversion rate
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively.
Measured: 30 days after full vaccination

Secondary outcomes (6)

AEs within 0-30 minutes after vaccination
The occurrence of all adverse events within 0-30 minutes after each dose of vaccination
Measured: 0-30 minutes after vaccination
Solicited AEs within 0-7 days after vaccination
The occurrence of all solicited adverse events within 0-7 days after each dose of vaccination
Measured: 0-7 days after vaccination
Unsolicited AEs within 0-30 days after vaccination
The occurrence of all unsolicited adverse events within 0-30 days after each dose of vaccination.
Measured: 0-30 days after vaccination
SAE within 0-6 months after primary immunization
The occurrence of all serious adverse events within 0-6 months after primary immunization.
Measured: 0-6 months after primary immunization
Positive rate of IgG antibodies
Positive rate of susceptible individuals with 15 serotype specific pneumococcal IgG antibodies (percentage of subjects with antibody concentration ≥ 0.35 μ g/ml)
Measured: 30 days after full vaccination
GMC of IgG antibody
GMC of IgG antibody against 15 serotype specific pneumococcal.
Measured: 30 days after full vaccination

Timeline

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

16 Sep 202113 Mar 2024

First posted10 Feb 2025
Study start16 Sep 2021
Primary completion13 Mar 2024
Study completion13 Mar 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Streptococcus Pneumoniae InfectionsStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 1,110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06817187
Sponsor's protocol ID: 201904003
Status last verified: Jan 2025
First submitted: 24 Jan 2025
Last updated: 10 Feb 2025
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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All Streptococcus Pneumoniae Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Center, Randomized, Open Label, Controlled Clinical Study to Evaluate the Mutual Influence of Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular Pertussis (Component) Combined Vaccine (Adsorbed)
ClinicalTrials.gov ID: NCT06817187
Acronym / sponsor ID: 201904003
Conditions: Streptococcus Pneumoniae Infections
Keywords: 15-valent pneumococcal conjugate vaccine, Diphtheria, Tetanus, Pertussis Vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,110 participants (actual)
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: 16 Sep 2021 (actual)
Primary completion: 13 Mar 2024 (actual)
Study completion: 13 Mar 2024 (actual)
First posted: 10 Feb 2025 (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.

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
P+DTP group	Experimental	Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)370 infants aged 3 months were enrolled in this group.
P-DTP group	Experimental	Biological: Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)370 infants aged 3 months were enrolled in this group.
DTP group	Active comparator	Biological: 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)370 infants aged 3 months were enrolled in this group.

Who may qualify

Ages: 3 to 3 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg;
The legal guardian provides informed consent and signs the informed consent form;
The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.

Key exclusion criteria (12 listed)

A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation;
Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine;
History or family history of seizures, epilepsy, encephalopathy, and mental illness;
Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage;
A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection;

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
15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Administer 0.5ml of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) separately at different locations upon enrollment. Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).	Biological	DTP group
15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Vaccination with 15-Valent Pneumococcal Conjugate Vaccine with a 7-day interval (+15 day window period) followed by vaccination with Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed). Both vaccine were immunized according to the 0, 1, and 2 month procedures (calculated as 30 days per month).	Biological	P+DTP group
Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed)Only administer the Diphtheria, Tetanus and Acellular pertussis (Component) Combined Vaccine (Adsorbed) and according to the 0, 1, and 2 month procedures (calculated as 30 days per month).	Biological	P-DTP group

Primary outcome

Antibody positive conversion rate
Time frame: 30 days after full vaccination
The positive conversion rates of diphtheria antibody (anti-D), tetanus antibody (anti-T), pertussis toxin antibody (anti-PT), and pertussis filamentous hemagglutinin antibody (anti-FHA) in P+DTP, P-DTP, and DTP groups，respectively.

6 secondary outcomes

AEs within 0-30 minutes after vaccination
Time frame: 0-30 minutes after vaccination
Solicited AEs within 0-7 days after vaccination
Time frame: 0-7 days after vaccination
Unsolicited AEs within 0-30 days after vaccination
Time frame: 0-30 days after vaccination
SAE within 0-6 months after primary immunization
Time frame: 0-6 months after primary immunization
Positive rate of IgG antibodies
Time frame: 30 days after full vaccination
GMC of IgG antibody
Time frame: 30 days after full 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 10 Feb 2025.

Related trials for Streptococcus Pneumoniae Infections

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
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RecruitingPhase 3
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
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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.

Lin Du, Doctor study chair

Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

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 3 inclusion and 12 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 10 Feb 2025. 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?

Antibody positive conversion rate (time frame: 30 days after full 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 NCT06817187.

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 10 Feb 2025.