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Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine

NCT03430089 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2022-11-09

No results posted yet for this study

Summary

This phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China.

Participants aged 9 years or more will receive a single dose of Shz QIV, and participants aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.

Conditions

Interventions

BIOLOGICAL

Shz QIV 0.25 mL, 2 doses

Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.

BIOLOGICAL

Shz QIV 0.5 mL, 2 doses

Administered intramuscularly into the deltoid muscle, 28 days apart

BIOLOGICAL

Shz QIV 0.5 mL, single dose

Administered intramuscularly into the deltoid muscle.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2019-06-06
Completion
2019-06-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03430089 on ClinicalTrials.gov