Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago

Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago - Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004631

Enrollment

100

Registered

2010-11-30

Start date

2010-12-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

healthy adults

Interventions

Single vaccination of seasonal influenza vaccine (0.5ml) subcutaneously.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Japanese healthy adults of 20 years old and over 2) Persons who received non-adjuvanted pandemic influenza H1N1 vaccination and persons who received AS03A-adjuvanted pandemic influenza H1N1 vaccination in 2009 3) Persons who give informed consent written voluntarily before participation in the study 4)Persons who can obey instrucions, keep diary, and tell side effects.

Exclusion criteria

Exclusion criteria: 1) Persons who have ever had serious adverse reactions after vaccination of non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine. 2) Persons who were given non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine for the last 10 months 3) Persons who have had seasonal influenza vaccination (2010/2011) 4) Persons who have ever showed anaphylaxis due to food or drugs 5) Persons who had past history of cardiovascular diseases, hematological diseases, pulmonary diseases, liver diseases, renal diseases, neurological diseases, and psychiatric diseases. 6) Persons who have had Guillain-Barre syndrome or acute disseminated encephalomyelitis 7) Persons who were given new drugs by participating the other trial within four months in the past. 8) Persons who were given live vaccine within 27 days in the past or inactivate vaccine within 6 days in the past. 9) Persons who will be given the other vaccine during this study. 10) Persons who were given blood transfusion or gamma globulin within 3 months in the past or who were given a great amount of gamma globulin (over 200 mg/kg) within 6 months in the past. 11) Persons who are not appropriate to participate in this study because of some reasons.

Design outcomes

Primary

Measure	Time frame
Immunogenicity: antibody titer on the 21st day and 6th month after vaccination	—

Secondary

Measure	Time frame
Immunogenicity: antibody titer on the 21st day and 6th month after vaccination Efficacy: morbidity of influenza during influenza season in 2010-201	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026