Evaluating a new pneumococcal vaccine in infants and young children

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

This study is testing a new pneumococcal vaccine in healthy infants and young children to see if it is safe and effective compared to other versions of the vaccine.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2346 (estimated)
• Ages: 3 Months to 5 Years
• Sex: All
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shijiangzhuang, Hebei)
• Trial ID: NCT05939219 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the consistency, immunogenicity, and safety of three batches of a 15-valent pneumococcal conjugate vaccine in healthy infants and children aged 3 months to 5 years. The study employs a randomized, double-blind, parallel controlled design to compare the immune responses of different vaccine batches and establish non-inferiority against pilot scale vaccines. Participants will receive the vaccine, and their immune responses will be monitored to ensure safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy infants and children aged 3 months, 7 months, and 5 years old.

Not a fit: Patients who have previously received pneumococcal vaccines or have a history of severe allergies to vaccines may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved vaccination strategies against pneumococcal diseases in young children.

How similar studies have performed: Other studies have shown success with similar pneumococcal vaccine approaches, indicating a promising avenue for immunization.

Eligibility criteria

Inclusion Criteria:

* 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 ℃.

Exclusion Criteria:

* 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.

Where this trial is running

Shijiangzhuang, Hebei

• Hebei Provincial Center for Disease Control and Prevention — Shijiangzhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Wenjian Fang, master

Conditions Healthy Volunteers; 15-valent pneumococcal conjugate vaccine