Influenza Clinical Trial
Official title:
A Phase IIIB, Observer-Blind, Randomized, Parallel Groups, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of a Sub-unit Adjuvanted or a Non-adjuvanted Influenza Vaccines in Healthy Children Previously Vaccinated in the V70P5 Study
Verified date | January 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: FIMEA - Finnish Medicines Agency |
Study type | Interventional |
This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.
Status | Completed |
Enrollment | 197 |
Est. completion date | December 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Months to 96 Months |
Eligibility |
Inclusion Criteria: - Healthy male or female children that have previously participated in the V70P5 study in Finland. Exclusion Criteria: - Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus | Biokatu 10, Tampere | |
Finland | Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor | Helsinki | |
Finland | Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor | Helsinki | |
Finland | Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17 | Järvenpää | |
Finland | Kokkola Vaccine Research Clinic, Rantakatu 7 | Kokkola | |
Finland | Kotka Vaccine Research Clinic, Karjalantie 10-12 | Kotka | |
Finland | Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188 | Kuopio | |
Finland | Lahti Vaccine Research Clinic, Vesijärvenkatu 74 | Lahti | |
Finland | Oulu Vaccine Research Clinic, Kiviharjunlenkki 6 | Oulu | |
Finland | Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor) | Pori | |
Finland | Seinäjoki Vaccine Research Clinic, Keskuskatu 6 | Seinäjoki | |
Finland | Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor) | Tampere | |
Finland | Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor | Tapiontori 1, Espoo | |
Finland | Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor) | Turku | |
Finland | Vantaa East, Vaccine Research Clinic, Asematie 11 a 16 | Vantaa | |
Finland | Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor | Vantaa |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
Finland,
Vesikari T, Forstén A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Hum Vaccin Immunother. 2015;11(8):2102-12. doi: 10.1080/21645515.2015.1044167. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection | 22 days post vaccination | Yes | |
Primary | Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion | 22 days post vaccination | Yes | |
Primary | Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion | 22 days post vaccination | Yes | |
Primary | Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received | 22 days post vaccination | Yes | |
Secondary | Primary immunogenicity outcomes as per CBER criteria | Day 22 | No | |
Secondary | Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains | Day 22 | No |
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