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NCT01210898 Clinical Trial

Immunogenicity and Safety of V70P5 Revaccination Subjects

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01210898
Other study ID # V70P5E1
Secondary ID 2010-021644-18
Status Completed
Phase Phase 3
First received September 28, 2010
Last updated November 30, 2016
Start date September 2010
Est. completion date December 2011

Study information
Verified date January 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Finland: FIMEA - Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Biological:
• Adjuvanted seasonal influenza vaccine
Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Finland, 

References & Publications (1)

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

Outcome
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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