JPRN-UMIN000004631
Completed
未知
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
ational Hospital Organization, Tokyo National Hospital0 sites100 target enrollmentNovember 30, 2010
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Hospital Organization, Tokyo National Hospital
- Enrollment
- 100
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Cohort assessing the immunogenicity and the safety of the COVID-19 Vaccine Janssen in healthy volunteers based on 3 age groups: 65 years or older - 55 to 65 years - 18 to 45 years - Covicompare-JanssevolunteersMedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Virus Diseases [C02]EUCTR2021-003191-14-FRCHU SAINT-ETIENNE180
Active, not recruiting
Phase 1
Administration of 9valent vaccine against papillomavirus in HIV-positive womeEUCTR2018-000228-33-BECHU Saint-Pierre200
Active, not recruiting
Phase 1
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers when Administered Concomitantly with Routine Pediatric Vaccines in the UK.EUCTR2017-004520-30-GBSanofi Pasteur700
Active, not recruiting
Phase 1
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeHealthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]EUCTR2017-004731-36-ITSanofi Pasteur Inc.1,540
Active, not recruiting
Phase 1
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeHealthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)MedDRA version: 20.0Level: PTClassification code 10027274Term: Meningococcal infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]EUCTR2017-004731-36-FISanofi Pasteur Inc.1,652