Healthy VolunteersNCT05939219
Consistency, Immunogenicity, and Safety of Three Batches of 15-valent Pneumococcal Conjugate Vaccine
A study testing 15-valent pneumococcal conjugate vaccine 202210001, 15-valent pneumococcal conjugate vaccineY202210002 and 15-valent pneumococcal conjugate vaccineY202210003 in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd at 1 site in China.
Trial summary
The objective of this clinical trial is to evaluate the consistency of the 15-valent pneumococcal conjugate vaccine in three batches of the 3-month-old population, as well as the immunogenicity and safety of vaccination in the 7-5-year-old population Read more about this study
- Who is it for?
- Ages 3 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- 15-valent pneumococcal conjugate vaccine 202210001, 15-valent pneumococcal conjugate vaccineY202210002 and 15-valent pneumococcal conjugate vaccineY202210003
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,346 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 30 Jun 2025
- Phase
- Interventional
- 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 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants and children aged 3 months, 7 months, and 5 years old;
- Infants under 1 year old should be born at full term (37 to 42 weeks of pregnancy) and have a birth weight within the range of (2500g ≤ body weight ≤ 4500g);
- After informed consent, the Legal guardian voluntarily signs the informed consent form and can comply with the requirements of the clinical research scheme;
- The subject has no history of receiving other live attenuated vaccines within ≤ 14 days, and no history of receiving other non live vaccines within ≤ 7 days;
- Underarm temperature ≤ 37.0 ℃.
Who cannot join
- Previously received commercially available or experimental pneumococcal vaccines;
- Have a history of invasive disease caused by Streptococcus pneumoniae that has been confirmed by culture in the past;
- Have a history of severe allergies to vaccines or medication;
- Have a history of Nervous system disease such as convulsion, epilepsy, nervous system tumor, craniocerebral trauma, psychiatric history or family history;
- Babies born under the age of 1 year with severe abnormal birth process (such as instrumental delivery) or a history of asphyxia or neurological organ damage;
- Patients with pathological jaundice confirmed by current diagnosis;
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- A history of clearly diagnosed thrombocytopenia or other coagulation disorders may lead to contraindications for injection;
- Immunoglobulin or any blood products (except hepatitis B immunoglobulin) were given within 3 months before enrollment;
- Known or suspected to have immunological function defects, and received long-term Immunosuppressive drug treatment (radiotherapy, chemotherapy, Corticosteroid, antimetabolics, cytotoxic drugs), HIV infection or HIV infected parents within six months before vaccination;
- Having severe congenital malformations, severe malnutrition, developmental disorders, or genetic defects (such as broad bean disease);
- Currently suffering from serious chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, and malignant tumor;
- Absence of spleen or deficiency of spleen function caused by any circumstances;
- Systemic rash, skin ringworm, skin suppuration or blisters;
- Participating in other clinical trials;
- Any situation that the researcher believes may affect the evaluation of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Provincial Center for Disease Control and Prevention
Shijiangzhuang, Hebei, 050021
Zhao Gao, Master, 17796915780, gaozhao123000@163.com
About this study
Official title: Clinical Study on the Consistency of 15-valent Pneumococcal Conjugate Vaccine in Three Batches of 3-month-old Population and the Immunogenicity and Safety of Vaccination in 7-5-year-old Population
The objective of this clinical trial is to evaluate the consistency of the 15-valent pneumococcal conjugate vaccine in three batches of the 3-month-old population, as well as the immunogenicity and safety of vaccination in the 7-5-year-old population
Read the detailed description
The purpose of this experiment
- evaluate the consistency of clinical immune efficacy of three batches of commercially produced 15-valent pneumococcal conjugate vaccines.
- Compare the immunogenicity of commercial scale produced 15-valent pneumococcal conjugate vaccines in the 3-month-old population with the immunogenicity (non inferiority) of pilot scale produced 15-valent pneumococcal conjugate vaccines, that is, a clinical bridging study between commercial scale vaccines and Phase III clinical trial vaccines.
- Evaluate the immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine in the 7-5-year-old population after vaccination.
The commercial three batches and pilot scale batches were designed using a randomized, double-blind, parallel controlled trial of different batches of vaccines. The commercial three batches adopt equivalence design, and the immunogenicity results of the three batches are merged on the basis of equivalence, and compared with the immunogenicity of the pilot scale batch for non-inferiority.
Compare the immunogenicity data of the 7-5-year-old population experimental group with the immunogenicity results of the 3-month-old group (after merging three commercial batches on an equivalent basis) at the basic immune stage for non-inferiority.
At the same time, a positive control was established in the 7-month-5-year-old population, and a randomized, blind design was used to compare the immunogenicity of the experimental group and the control group in this age group.
The study population consists of a total of 2346 people, including 1104 people at the age of 3 months, divided into four groups with 276 people in each group. They were assigned to batch 1, batch 2, batch 3, and the pilot scale module at a ratio of 1:1:1:1. There are a total of 1242 people aged 7 months to 5 years old, divided into three age groups: 7-11 months old, 12-23 months old, and 2-5 years old, with 414 people in each age group. Three age groups of participants were randomly assigned to the experimental group or control group in a 2:1 ratio. The experimental group received a 15-valent pneumococcal conjugate vaccine (batch 3), while the control group received a 13-valent pneumococcal polysaccharide conjugate vaccine produced by Yuxi Watson Biotechnology Co., Ltd. Among them:
- 3 months old: Basic immunization according to the 0, 1, and 2 month program (window period:+10 days); Strengthen immunization with 1 dose at the age of 12-15 months.
- 7-11 months of age: basic immunization with a 0 to 2-month program (window period:+10 days); After 12 months of age, strengthen the vaccination with 1 dose (3rd dose), with a minimum interval of 2 months between the 2nd dose.
- 12-23 months old: Immunize with 2 doses of 0 and 2 month program. The interval between two doses of vaccination should be at least 2 months (window period:+10 days).
- 2-5 years old: receive 1 dose.
- Conditions
- Healthy Volunteers
- Being tested
- 15-valent pneumococcal conjugate vaccine 202210001, 15-valent pneumococcal conjugate vaccineY202210002, 15-valent pneumococcal conjugate vaccineY202210003, 15-valent pneumococcal conjugate vaccineY202210004, 13 valent pneumococcal polysaccharide conjugate vaccine
- Keywords
- 15-valent pneumococcal conjugate vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15-valent pneumococcal conjugate vaccine 202210001Biological
Immunization program and dosage:3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
15-valent pneumococcal conjugate vaccineY202210002Biological
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
15-valent pneumococcal conjugate vaccineY202210003Biological
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
15-valent pneumococcal conjugate vaccineY202210004Biological
Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
13 valent pneumococcal polysaccharide conjugate vaccineBiological
Immunization program and dosage: 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered
| Study group | Role | What they receive |
|---|---|---|
| 3-month-old group | Experimental | Randomly inoculate 4 batches of 15-valent pneumococcal conjugate vaccine. Immunization program and dosage: Basic immunization at 0, 1, and 2 months, booster immunization at 12-15 months of age, a total of 4 doses administered.
Dosage form: water injection type Receives: Biological: 15-valent pneumococcal conjugate vaccine 202210001; Biological: 15-valent pneumococcal conjugate vaccineY202210002; Biological: 15-valent pneumococcal conjugate vaccineY202210003; Biological: 15-valent pneumococcal conjugate vaccineY202210004 |
| 7-11 month old experimental group | Experimental | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: Basic immunization for 0 and 2 months program; Strengthen one dose after 12 months of age; A total of 3 doses were administered.
Dosage form: water injection type Receives: Biological: 15-valent pneumococcal conjugate vaccineY202210004 |
| 7-11 month old control group | Active comparator | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: Basic immunization for 0 and 2 months program; Strengthen one dose after 12 months of age; A total of 3 doses were administered.
Dosage form: water injection type Receives: Biological: 13 valent pneumococcal polysaccharide conjugate vaccine |
| 12-23 months old experimental group | Experimental | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: Immunize 2 doses using the 0 and 2 month program, with a total of 2 doses administered.
Dosage form: water injection type Receives: Biological: 15-valent pneumococcal conjugate vaccineY202210004 |
| 12-23 months old control group | Active comparator | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: Immunize 2 doses using the 0 and 2 month program, with a total of 2 doses administered.
Dosage form: water injection type Receives: Biological: 13 valent pneumococcal polysaccharide conjugate vaccine |
| 2-5 year old experimental group | Experimental | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: 1 dose administered. Dosage form: water injection type Receives: Biological: 15-valent pneumococcal conjugate vaccineY202210004 |
| 2-5 year old control group | Active comparator | The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1.
Immunization program and dosage: 1 dose administered. Dosage form: water injection type 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.
Geometric mean concentration of vaccine Serotype specific pneumococcal IgG antibody
Immunogenicity evaluation
Measured: 30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Vaccine Serotype specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml of proportion of subjects
Immunogenicity evaluation
Measured: 30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Du, master, Study chair, Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939219
- Sponsor's protocol ID
- 202204025
- Status last verified
- Jul 2023
- First submitted
- 3 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Consistency of 15-valent Pneumococcal Conjugate Vaccine in Three Batches of 3-month-old Population and the Immunogenicity and Safety of Vaccination in 7-5-year-old Population
- ClinicalTrials.gov ID
- NCT05939219
- Acronym / sponsor ID
- 202204025
- Conditions
- Healthy Volunteers
- Keywords
- 15-valent pneumococcal conjugate vaccine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,346 participants (estimated)
- Lead sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 11 Jul 2023 (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.
The objective of this clinical trial is to evaluate the consistency of the 15-valent pneumococcal conjugate vaccine in three batches of the 3-month-old population, as well as the immunogenicity and safety of vaccination in the 7-5-year-old population
Detailed description
The purpose of this experiment
- evaluate the consistency of clinical immune efficacy of three batches of commercially produced 15-valent pneumococcal conjugate vaccines.
- Compare the immunogenicity of commercial scale produced 15-valent pneumococcal conjugate vaccines in the 3-month-old population with the immunogenicity (non inferiority) of pilot scale produced 15-valent pneumococcal conjugate vaccines, that is, a clinical bridging study between commercial scale vaccines and Phase III clinical trial vaccines.
- Evaluate the immunogenicity and safety of the 15-valent pneumococcal conjugate vaccine in the 7-5-year-old population after vaccination.
The commercial three batches and pilot scale batches were designed using a randomized, double-blind, parallel controlled trial of different batches of vaccines. The commercial three batches adopt equivalence design, and the immunogenicity results of the three batches are merged on the basis of equivalence, and compared with the immunogenicity of the pilot scale batch for non-inferiority.
Compare the immunogenicity data of the 7-5-year-old population experimental group with the immunogenicity results of the 3-month-old group (after merging three commercial batches on an equivalent basis) at the basic immune stage for non-inferiority.
At the same time, a positive control was established in the 7-month-5-year-old population, and a randomized, blind design was used to compare the immunogenicity of the experimental group and the control group in this age group.
The study population consists of a total of 2346 people, including 1104 people at the age of 3 months, divided into four groups with 276 people in each group. They were assigned to batch 1, batch 2, batch 3, and the pilot scale module at a ratio of 1:1:1:1. There are a total of 1242 people aged 7 months to 5 years old, divided into three age groups: 7-11 months old, 12-23 months old, and 2-5 years old, with 414 people in each age group. Three age groups of participants were randomly assigned to the experimental group or control group in a 2:1 ratio. The experimental group received a 15-valent pneumococcal conjugate vaccine (batch 3), while the control group received a 13-valent pneumococcal polysaccharide conjugate vaccine produced by Yuxi Watson Biotechnology Co., Ltd. Among them:
- 3 months old: Basic immunization according to the 0, 1, and 2 month program (window period:+10 days); Strengthen immunization with 1 dose at the age of 12-15 months.
- 7-11 months of age: basic immunization with a 0 to 2-month program (window period:+10 days); After 12 months of age, strengthen the vaccination with 1 dose (3rd dose), with a minimum interval of 2 months between the 2nd dose.
- 12-23 months old: Immunize with 2 doses of 0 and 2 month program. The interval between two doses of vaccination should be at least 2 months (window period:+10 days).
- 2-5 years old: receive 1 dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 3-month-old group | Experimental | Biological: 15-valent pneumococcal conjugate vaccine 202210001, Biological: 15-valent pneumococcal conjugate vaccineY202210002, Biological: 15-valent pneumococcal conjugate vaccineY202210003, Biological: 15-valent pneumococcal conjugate vaccineY202210004Randomly inoculate 4 batches of 15-valent pneumococcal conjugate vaccine. Immunization program and dosage: Basic immunization at 0, 1, and 2 months, booster immunization at 12-15 months of age, a total of 4 doses administered. Dosage form: water injection type |
| 7-11 month old experimental group | Experimental | Biological: 15-valent pneumococcal conjugate vaccineY202210004The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: Basic immunization for 0 and 2 months program; Strengthen one dose after 12 months of age; A total of 3 doses were administered. Dosage form: water injection type |
| 7-11 month old control group | Active comparator | Biological: 13 valent pneumococcal polysaccharide conjugate vaccineThe experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: Basic immunization for 0 and 2 months program; Strengthen one dose after 12 months of age; A total of 3 doses were administered. Dosage form: water injection type |
| 12-23 months old experimental group | Experimental | Biological: 15-valent pneumococcal conjugate vaccineY202210004The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: Immunize 2 doses using the 0 and 2 month program, with a total of 2 doses administered. Dosage form: water injection type |
| 12-23 months old control group | Active comparator | Biological: 13 valent pneumococcal polysaccharide conjugate vaccineThe experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: Immunize 2 doses using the 0 and 2 month program, with a total of 2 doses administered. Dosage form: water injection type |
| 2-5 year old experimental group | Experimental | Biological: 15-valent pneumococcal conjugate vaccineY202210004The experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: 1 dose administered. Dosage form: water injection type |
| 2-5 year old control group | Active comparator | Biological: 13 valent pneumococcal polysaccharide conjugate vaccineThe experimental group was vaccinated with the 15 valent pneumococcal conjugate vaccine, while the control group was vaccinated with the 13 valent pneumococcal polysaccharide conjugate vaccine, with a ratio of 2:1. Immunization program and dosage: 1 dose administered. Dosage form: water injection type |
Who may qualify
- Ages
- 3 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants and children aged 3 months, 7 months, and 5 years old;
- Infants under 1 year old should be born at full term (37 to 42 weeks of pregnancy) and have a birth weight within the range of (2500g ≤ body weight ≤ 4500g);
- After informed consent, the Legal guardian voluntarily signs the informed consent form and can comply with the requirements of the clinical research scheme;
- The subject has no history of receiving other live attenuated vaccines within ≤ 14 days, and no history of receiving other non live vaccines within ≤ 7 days;
- Underarm temperature ≤ 37.0 ℃.
Key exclusion criteria (15 listed)
- Previously received commercially available or experimental pneumococcal vaccines;
- Have a history of invasive disease caused by Streptococcus pneumoniae that has been confirmed by culture in the past;
- Have a history of severe allergies to vaccines or medication;
- Have a history of Nervous system disease such as convulsion, epilepsy, nervous system tumor, craniocerebral trauma, psychiatric history or family history;
- Babies born under the age of 1 year with severe abnormal birth process (such as instrumental delivery) or a history of asphyxia or neurological organ damage;
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 202210001Immunization program and dosage:3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered | Biological | 3-month-old group |
| 15-valent pneumococcal conjugate vaccineY202210002Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered | Biological | 3-month-old group |
| 15-valent pneumococcal conjugate vaccineY202210003Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered | Biological | 3-month-old group |
| 15-valent pneumococcal conjugate vaccineY202210004Immunization program and dosage: 3 month old group: basic immunization at 0, 1, and 2 months, and strengthened immunization at 12 to 15 months old, with a total of 4 doses administered. 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered | Biological | 12-23 months old experimental group, 2-5 year old experimental group, 3-month-old group, 7-11 month old experimental group |
| 13 valent pneumococcal polysaccharide conjugate vaccineImmunization program and dosage: 7-11 month old group: baseline immunization at 0 and 2 months; Strengthen one dose after 12 months of age; A total of 3 doses were administered. 12-23 month old group: Immunized with 2 doses of 0 and 2 month program, a total of 2 doses were administered. 2-5 year old group: 1 dose administered | Biological | 12-23 months old control group, 2-5 year old control group, 7-11 month old control group |
Primary outcome
Geometric mean concentration of vaccine Serotype specific pneumococcal IgG antibody
Time frame: 30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Immunogenicity evaluation
Vaccine Serotype specific pneumococcal IgG antibody concentration ≥ 0.35 μg/ml of proportion of subjects
Time frame: 30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old
Immunogenicity evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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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, master 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?
A study testing 15-valent pneumococcal conjugate vaccine 202210001, 15-valent pneumococcal conjugate vaccineY202210002 and 15-valent pneumococcal conjugate vaccineY202210003 in people with Healthy Volunteers, run by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd 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 15 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: status not confirmed, as of the sponsor's last update on 12 Jul 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenjian Fang, master (18611630252, fangwenjian@zhifeishengwu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean concentration of vaccine Serotype specific pneumococcal IgG antibody (time frame: 30 days after basic immunization at 3 months old and 7-11 months old, and 30 days after full immunization at 12-23 months old and 2-5 years old). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2023.