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Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China

NCT02228980 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 602

Last updated 2016-01-29

Study results available
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Summary

The main purpose of this trial is to describe the product profile in terms of immunogenicity and safety following administration of trivalent influenza vaccine (split-virion, inactivated) produced at Shenzhen (SP Shz TIV).

Primary objective:

* To describe in each group the immune response induced by a single dose (subjects aged ≥ 3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

Secondary objective:

* To describe in each group the safety profile of the vaccine after a single dose (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35 months).

Conditions

Interventions

BIOLOGICAL

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

0.25 mL Intramuscular (2 doses given 28 days apart)

BIOLOGICAL

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

0.5 mL Intramuscular

BIOLOGICAL

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

0.5 mL Intramuscular

BIOLOGICAL

Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation

0.5 mL Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur SA

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2015-10-31

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 NCT02228980 on ClinicalTrials.gov