Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China

A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00325260

Enrollment

900

Registered

2006-05-12

Start date

2006-03-31

Completion date

Unknown

Last updated

2006-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

influenza, non-inferiority, Influvac, Agrippal, healthy subjects

Brief summary

In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.

Interventions

BIOLOGICALInfluvac; subunit influenza vaccine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* signed and dated informed consent * being healthy * mental health enough to understand the study, the informed consent form and the questionnaire

Exclusion criteria

* known to be allergic to constituents of the vaccine * having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV * having had a documented serious adverse reaction to previous influenza vaccination * having had documented influenza infection or vaccination in the six months prior to the start of the study * having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study

Design outcomes

Primary

Measure	Time frame
HI titers 4 weeks after vaccination (efficacy) and safety and tolerability	—

Secondary

Measure	Time frame
HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026