NCT05939219

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,346

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

July 3, 2023

Last Update Submit

July 11, 2023

Conditions

Healthy Volunteers

Keywords

15-valent pneumococcal conjugate vaccine

Outcome Measures

Primary Outcomes (2)

  • Geometric mean concentration of vaccine Serotype specific pneumococcal IgG antibody

    Immunogenicity evaluation

    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

    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

Study Arms (7)

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

Biological: 15-valent pneumococcal conjugate vaccine 202210001Biological: 15-valent pneumococcal conjugate vaccineY202210002Biological: 15-valent pneumococcal conjugate vaccineY202210003Biological: 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

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

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

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

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

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

Biological: 13 valent pneumococcal polysaccharide conjugate vaccine

Interventions

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

3-month-old group
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

3-month-old group
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

3-month-old group
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

12-23 months old experimental group2-5 year old experimental group3-month-old group7-11 month old experimental group
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

12-23 months old control group2-5 year old control group7-11 month old control group

Eligibility Criteria

Age3 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 ℃.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Provincial Center for Disease Control and Prevention

Shijiangzhuang, Hebei, 050021, China

RECRUITING

Study Officials

  • Lin Du, master

    Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

    STUDY CHAIR

Central Study Contacts

Wenjian Fang, master

CONTACT

18611630252fangwenjian@zhifeishengwu.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

July 1, 2023

Primary Completion

January 31, 2025

Study Completion

June 30, 2025

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

CN(1)