NCT00519389

CompletedPhase 1/2

Safety, Reactogenicity and Immunogenicity of an H5N1 VLP

Novavax Source

Novavax

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

H5N1 VLP-1

Study Type

interventional

Actual enrollment (reported)

230

Locations

1 country

Sites

1

Timeline

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2008

Actual (reported)

Study Completion

November 2008

Actual (reported)

Brief Summary

This is a Phase I/IIa randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of H5N1 VLP vaccine or placebo in healthy adults 18 to 40 years of age.

Registry Overview

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

Recruitment status: completed
Actual enrollment (reported): 230 participants
Study completion date: November 2008
Actual (reported)
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
July 2007
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
August 20, 2007
Actual (reported)
First Posted
August 22, 2007
Actual (reported)
Primary Completion
November 2008
Actual (reported)
Study Completion
November 2008
Actual (reported)

Last Updated: June 21, 2013
Status Verified: March 2012
Last Update Submitted: June 12, 2013

Conditions

Pandemic Influenza

Outcome Measures

Primary Outcomes (1)

Safety and reactogenicity of H5N1 VLP Vaccine
6 months

Secondary Outcomes (1)

Immunogenicity of H5N1 VLP Influenza vaccine
6 months

Study Arms (4)

Low dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

Mid dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

High dose H5N1 VLP Vaccine

EXPERIMENTAL

Biological: H5N1 VLP Vaccine

Placebo

PLACEBO COMPARATOR

Interventions

H5N1 VLP VaccineBiological

Two doses - Day 0 \& Day 28

High dose H5N1 VLP VaccineLow dose H5N1 VLP VaccineMid dose H5N1 VLP Vaccine

PlaceboBiological

Two doses - Day 0 \& Day 28

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female 18 to 40 years of age at the time of the vaccination.
Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool).

Sponsors & Collaborators

Novavax
Industrylead

Study Sites (1)

Healthcare Discoveries, Inc.

San Antonio, Texas, 78209, United States

Study Officials

George Atiee, M.D.
Healthcare Discoveries, Inc.
PRINCIPAL INVESTIGATOR

Enrollment

230 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

July 2007

Date type not reported

This date has not been verified as actual or estimated.

NCT00976469

A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents

Phase 1/2Completed

NCT00970177

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

Phase 3Completed

NCT00971906

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

Phase 3Completed

NCT00971100

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age

Phase 3Completed

NCT00971542

Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

Phase 3Completed

NCT00640211

A Prospective Study to Examine the Effectiveness and Safety of Neuraminidase Inhibitors in Volunteers Who Receive Long-term Prophylaxis Against Pandemic Influenza: PIPET B

Withdrawn

Biological: Placebo

Placebo

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

Available by telephone.

Free of obvious health problems as established by medical history and clinical examination before entering the study.

If subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. She must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination.

Must provide written, informed consent.

You may not qualify if:

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
Has received any other licensed vaccines within 4 weeks prior to enrollment in this study.
Has received any influenza vaccine within the prior 12 month period.
Has received any investigational vaccine designed for protection against avian influenza.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. The use of inhaled and nasal steroids will be permitted.
Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study.
Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º F.
Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures, with the exception of febrile seizures during childhood.

Contact the study team to confirm eligibility.

Primary Completion

November 2008

Actual (reported)

Study Completion

November 2008

Actual (reported)

Last Updated

June 21, 2013

Record last verified: 2012-03

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: NCT00519389
Data provider: ClinicalTrials.gov
Source updated: 2013-06-21
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:36 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

Low dose H5N1 VLP Vaccine

Mid dose H5N1 VLP Vaccine

High dose H5N1 VLP Vaccine

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations