A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

NCT06342349 | Completed Phase 1

• 1 other identifier: SIBP-V03-I
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.

Conditions

Influenza

Keywords

Quadrivalent influenza virus split vaccine; MDCK cells; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (3)

• Solicited Adverse Events (AEs)

  Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination.

  7 days after each dose of vaccination

• Unsolicited Adverse Events

  Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.

  28 or 30 days after each dose of vaccination

• Serious Adverse Events (SAE)

  That is serious adverse events, any serious adverse events that occurred to the participant during the study period.

  6 months after the last dose

Secondary Outcomes (3)

• Seroconversion rate

  30 days after the last dose of vaccination

• Ratio of ≥1:40

  30 days after the last dose of vaccination

• Geometric mean increase (GMI)

  30 days after the last dose of vaccination

Study Arms (3)

SIBP-V03-I

EXPERIMENTAL

Quadrivalent influenza virus split vaccine (MDCK cells)

Biological: Quadrivalent influenza virus split vaccine (MDCK cells)

QTV (chicken embryo)

ACTIVE COMPARATOR

Quadrivalent influenza virus split vaccine (chicken embryo)

Biological: Quadrivalent influenza virus split vaccine (Chicken embryo)

Placebo

PLACEBO COMPARATOR

Phosphate buffer solution

Other: Phosphate buffer solution

Interventions

Quadrivalent influenza virus split vaccine (MDCK cells) BIOLOGICAL

Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).

SIBP-V03-I

Quadrivalent influenza virus split vaccine (Chicken embryo) BIOLOGICAL

Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).

QTV (chicken embryo)

Phosphate buffer solution OTHER

Phosphate buffer solution without vaccine antigen(0.5ml/dose).

Placebo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy individuals aged 6 months or more on the day of enrollment who can provide legal identification documents.
• Volunteers and/or their legal guardians (or entrusted persons) have informed consent, voluntarily participate, and sign an informed consent form.
• Volunteers and/or their legal guardians (or entrusted persons) have the ability (non-illiterate) to understand the research procedures, could use thermometers, scales, and fill out diary cards as required, and can comply with the requirements of the clinical trial protocol to complete the clinical study.

You may not qualify if:

• On the day of enrollment, the underarm temperature of individuals ≤ 14 years old is ≥ 37.5 ℃, and on the day of enrollment, the underarm temperature of individuals\>14 years old is ≥ 37.3 ℃.
• Women of childbearing age (from menarche to menopause for ≤ 1 year) who have tested positive for urinary pregnancy test, and those who are breastfeeding, pregnant, or planning to conceive within 6 months.
• Have had or are currently suffering from influenza within the past 3 months (confirmed by clinical, serological, or microbiological methods).
• Individuals aged 6 months to 8 years have previously received any influenza vaccine (including registered or experimental) or have planned to receive any influenza vaccine during the study period. Individuals aged 9 and above have received any influenza vaccine (including registered or experimental) within the past 6 months or have planned to receive any influenza vaccine within the past 6 months.
• Has a history of allergic reactions to any component of the research vaccine, including consuming eggs or using gentamicin sulfate.
• Has any history of severe allergies to vaccines or drugs in the past. Population aged 6 to 35 months: premature birth (delivered before the 37th week of pregnancy), low birth weight (birth weight\<2500g) infants.
• Population aged 6 to 35 months: those with a history of difficult childbirth, suffocation rescue, and neurological damage.
• Congenital malformations (clinically significant according to researchers) or developmental disorders, genetic defects, and severe malnutrition.
• Population aged 3-8 years and 6-35 months: individuals with abnormal growth and development, severe eczema.
• Suffering from acute illness or being in the acute phase of chronic illness within 3 days before vaccination.
• Used antipyretic and analgesic drugs or anti allergic drugs within 3 days before vaccination.
• Suffering from serious chronic diseases, serious cardiovascular diseases, hypertension beyond drug control (systolic pressure ≥ 140mmHg or diastolic pressure ≥ 90mmHg, only applicable to people aged 18 and above), diabetes with complications, liver and kidney diseases, malignant tumors, etc.
• Have a history of receiving attenuated live vaccines within 14 days (including the 14th day) before vaccination and have a history of receiving other vaccines within 7 days (including the 7th day).
• Individuals who receive immunotherapy or immunosuppressive therapy within 3 months (continuous oral or intravenous for more than 14 days).
• Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, or other autoimmune diseases.

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Shanxi Provincial Center for Disease Prevention and Control

Shanxi, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Guohua Li

  0351-7553168

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single center, randomized, double-blind, controlled phase I clinical trial.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 2, 2024
• Study Start: March 30, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)