Immunogenicity and Safety Study of 15-Valent Pneumococcal Conjugate Vaccine in 2-month-old and 3-month-old Healthy Volunteers

NCT04357522 | Not Yet Recruiting Phase 3

• 1 other identifier: 201904002
• Study Type: interventional
• Target: 1,950
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate Immunogenicity and safety of 15-Valent Pneumococcal Conjugate Vaccine in healthy volunteers aged 2 and 3 months.

Conditions

Pneumonia, Pneumococcal

Outcome Measures

Primary Outcomes (2)

• Immunogenicity study endpoint

  Percentage of participants with seroresponse to each vaccination

  30 day after each vaccination

• Safety study endpoint

  Occurrence of adverse events during a 30 day follow-up period after each vaccination

  30 day after each vaccination

Study Arms (2)

experimental group

EXPERIMENTAL

Received Vaccine: 15-valent pneumococcal Conjugate Vaccine(experimental vaccine), 0.5 ml/dose

Biological: 15-Valent Pneumococcal Conjugate Vaccine

Positive control group

ACTIVE COMPARATOR

Received Vaccine: 13-valent pneumococcal Conjugate Vaccine(positive control vaccine), 0.5 ml/dose

Biological: 13-Valent Pneumococcal Conjugate Vaccine

Interventions

15-Valent Pneumococcal Conjugate Vaccine BIOLOGICAL

4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.

experimental group

13-Valent Pneumococcal Conjugate Vaccine BIOLOGICAL

4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.

Positive control group

Eligibility Criteria

• Age: 6 Weeks - 3 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged above 2 months (minimum to 6 weeks), term (37-42 weeks gestation) and birth weight ≥2.5 kg.
• The guardian understands the vaccination and research procedures, volunteers to participate in the research and sign the informed consent.
• The guardian can follow the clinical research program, will be able to follow up until 3 years after booster immunization and have the ability to use thermometers, scale and fill in diary and contact cards as required.
• There was no history of other live vaccines in the past 14 days and no history of other inactivated vaccines in the seventh day.
• Subaxillary body temperature \<=37.0 C.
• Determine health based on medical history, physical examination, and researcher's judgment.

You may not qualify if:

• Have been vaccinated a listed or experimental pneumococcal vaccine.
• History of invasive diseases caused by Streptococcus pneumoniae confirmed by bacterial culture in the past.
• In the past, there was any history of vaccination or serious allergy to drugs. In the past, fever of over 39.5 C related to vaccination occurred in biological products for vaccination and prophylaxis.
• History of convulsion, epilepsy, encephalopathy and psychiatry or family history.
• Had abnormal labor (dystocia, device midwifery), history of asphyxia rescue and nerve organ damage.
• History of pathological jaundice confirmed by diagnosis.
• A history of thrombocytopenia or other coagulation disorders with definite diagnosis.
• Human serum gamma globulin injection after birth.
• There are known or suspected immunological abnormalities, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), HIV infection, etc.
• Congenital malformations, severe malnutrition, developmental disorders, genetic defects (e.g. broad bean disease).
• Severe chronic disease, infectious disease, active infection, liver disease, kidney disease, cardiovascular disease, malignant tumor.
• Severe asthma.
• Systemic rash, dermatophytes, skin pus or blister.
• Participation in other drug clinical trials.
• Anything that the researcher considers likely to affect the evaluation of the study.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (3)

Daming Center for Disease Control and Prevention

Daming, Hebei, 056900, China

Location

Laishui Center for Disease Control and Prevention

Laishui, Hebei, 074199, China

Location

Zhengding Center for Disease Control and Prevention

Zhengding, Hebei, 050800, China

Location

MeSH Terms

Conditions

Pneumonia, Pneumococcal

Condition Hierarchy (Ancestors)

Pneumococcal Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Du Lin, Master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 20, 2020
• First Posted: April 22, 2020
• Study Start: July 1, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

CN (3)