NCT00161837

CompletedPhase 2/3

Comparison of the Safety and Immune Response of an Influenza...

Alachua Government Services, Inc.Source

Alachua Government Services, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

227

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2004

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: July 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
July 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 8, 2005
Actual (reported)
First Posted
September 13, 2005
Actual (reported)

Last Updated: October 9, 2015
Status Verified: October 2006
Last Update Submitted: October 7, 2015

Conditions

Influenza

Keywords

InfluenzaVaccine

Interventions

Vero Cell-derived Influenza VaccineBiological

Egg-derived Influenza VaccineBiological

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Male and female subjects will be eligible for participation in this study if they:
are \>= 18 and \<= 60 years old (for Stratum A only);

Sponsors & Collaborators

Alachua Government Services, Inc.
Industrylead

Study Sites (1)

PANTAMED Sp.z o.o.

Olsztyn, PL-10-461, Poland

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Jerzy Romaszko, MD
PANTAMED sp. z o o.
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: SINGLE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

December 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2004

Date type not reported

Phase 2/3

Completed

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Phase 2/3Completed

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Phase 2/3Completed

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Tolerability, Safety and Immunogenicity Trial of the FLU-M® Tetra

Phase 2/3Completed

NCT00996138

Single-blind, Dose-ranging Study of Novel Swine Influenza Virus Vaccine in Japanese Adult Subjects

Phase 2/3Completed

NCT07893847

Evaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza

Phase 2/3Not Yet Recruiting

NCT03849560

Safety, Reactogenicity, Immunogenicity, Efficacy of Influenza Vaccines Grippol® Quadri and Grippol® Plus in Volunteers

Phase 2/3Completed

are \> 60 years old (for Stratum B only);

are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;

will reliably keep a daily record of symptoms;

understand the nature of the study, agree to its provisions, and give written informed consent;

if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

You may not qualify if:

Male and female subjects will be excluded from participation in this study if they:
have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
suffer from any kind of immunodeficiency;
suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
have received a blood transfusion or immunoglobulins within one month of study entry;
have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
have a rash or dermatological condition which may interfere with injection site reaction rating;
have a known or suspected problem with drug or alcohol abuse;
are unable to lead an independent life either physically or mentally;
had administration of an investigational drug within six weeks prior to the study start;
are concurrently participating in a clinical trial;
are pregnant or lactating.

Contact the study team to confirm eligibility.

This date has not been verified as actual or estimated.

Last Updated

October 9, 2015

Record last verified: 2006-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00161837
Data provider: ClinicalTrials.gov
Source updated: 2015-10-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:32 UTC

Locations

PL(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations