Immunogenicity and Safety Study of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Primed Adults

A Multicenter, Open-Label Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Recombinant H5N1 Influenza HA Vaccine in Healthy Young Adults Primed With a Two-Vaccination of a Recombinant H5N1 Influenza HA Vaccine

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01195038

Enrollment

Registered

2010-09-03

Start date

2010-10-31

Completion date

2011-01-31

Last updated

2011-02-08

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

Conditions

Influenza

Keywords

Avian influenza, H5N1, pandemic, recombinant HA vaccine

Brief summary

The study is designed to assess the immunogenicity and safety of one booster vaccination with 45 μg of a recombinant H5N1 influenza (A/Indonesia/05/2005) HA vaccine in healthy young adults, previously primed with a two-vaccination of 3 different doses of a recombinant H5N1 influenza (A/Vietnam/1203/2004) HA vaccine in a priming study (JPIP501-01a, NCT00980447).

Interventions

BIOLOGICALRecombinant Influenza HA Vaccine (H5N1)

one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 41 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects who completed a priming study (JPIP501-01a, NCT00980447) * Male and female healthy adults * Written informed consent obtained from the subject before study entry

Exclusion criteria

* History of H5N1 influenza or vaccination of other H5N1 influenza vaccines * Clinically diagnosed cardiovascular, hematological, psychological, neurological, hepatic, renal, pulmonary (including asthma), endocrinological or gastrointestinal disorder * Confirmed immune deficiency conditions, or diagnosed autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus * Severe allergic reactions or anaphylaxis to foods or drugs (including vaccines) * Treatment with disallowed drugs including other study drugs * Pregnant or nursing (lactating) women Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Percentage of subjects achieving seroconversion 21 days after a booster vaccination, as measured by hemagglutination inhibition (HI) assay against H5N1 influenza viruses (A/Indonesia/05/2005 & A/Vietnam/1203/2004)	Day 21

Secondary

Measure	Time frame
Percentage of subjects achieving seroprotection or significant increase in antibody titer on each blood sampling days after a booster vaccination, as measured by HI and microneutralization assays against the H5N1 influenza viruses	Days 7, 21
Incidence of adverse events including solicited local or systemic reactions until 21 days after a booster vaccination	21 days

Countries

Japan

Outcome results

None listed

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