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Immunogenicity and Safety of V70P5 Revaccination Subjects

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Adjuvanted seasonal influenza vaccine

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Trivalent, Adjuvanted, Vaccine, Children

Eligibility Criteria

18 Months - 96 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus
Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor
Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor
Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17
Kokkola Vaccine Research Clinic, Rantakatu 7
Kotka Vaccine Research Clinic, Karjalantie 10-12
Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188
Lahti Vaccine Research Clinic, Vesijärvenkatu 74
Oulu Vaccine Research Clinic, Kiviharjunlenkki 6
Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor)
Seinäjoki Vaccine Research Clinic, Keskuskatu 6
Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor)
Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor
Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor)
Vantaa East, Vaccine Research Clinic, Asematie 11 a 16
Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Group 4

Group 5

Group 6

Group 7

Group 8

Group 9

Group 10

Group 11

Group 12

Group 13

Arm Description

Outcomes

Primary Outcome Measures

Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection

Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received

Secondary Outcome Measures

Primary immunogenicity outcomes as per CBER criteria

Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains

Full Information

NCT ID

NCT01210898

First Posted

September 28, 2010

Last Updated

November 30, 2016

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01210898

Brief Title

Immunogenicity and Safety of V70P5 Revaccination Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza, Trivalent, Adjuvanted, Vaccine, Children

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

197 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Title

Group 2

Arm Type

Experimental

Arm Title

Group 3

Arm Type

Experimental

Arm Title

Group 4

Arm Type

Experimental

Arm Title

Group 5

Arm Type

Experimental

Arm Title

Group 6

Arm Type

Experimental

Arm Title

Group 7

Arm Type

Experimental

Arm Title

Group 8

Arm Type

Experimental

Arm Title

Group 9

Arm Type

Experimental

Arm Title

Group 10

Arm Type

Experimental

Arm Title

Group 11

Arm Type

Experimental

Arm Title

Group 12

Arm Type

Experimental

Arm Title

Group 13

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Adjuvanted seasonal influenza vaccine

Intervention Description

Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

Primary Outcome Measure Information:

Title

Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection

Time Frame

22 days post vaccination

Title

Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

Time Frame

22 days post vaccination

Title

Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

Time Frame

22 days post vaccination

Title

Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received

Time Frame

22 days post vaccination

Secondary Outcome Measure Information:

Title

Primary immunogenicity outcomes as per CBER criteria

Time Frame

Day 22

Title

Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains

Time Frame

Day 22

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

96 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus

City

Biokatu 10, Tampere

ZIP/Postal Code

FI-33520

Country

Finland

Facility Name

Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor

City

Helsinki

ZIP/Postal Code

FI-00100

Country

Finland

Facility Name

Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor

City

Helsinki

ZIP/Postal Code

FI-00930

Country

Finland

Facility Name

Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17

City

Järvenpää

ZIP/Postal Code

FI-04400

Country

Finland

Facility Name

Kokkola Vaccine Research Clinic, Rantakatu 7

City

Kokkola

ZIP/Postal Code

FI-67100

Country

Finland

Facility Name

Kotka Vaccine Research Clinic, Karjalantie 10-12

City

Kotka

ZIP/Postal Code

FI-48600

Country

Finland

Facility Name

Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

Lahti Vaccine Research Clinic, Vesijärvenkatu 74

City

Lahti

ZIP/Postal Code

FI-15140

Country

Finland

Facility Name

Oulu Vaccine Research Clinic, Kiviharjunlenkki 6

City

Oulu

ZIP/Postal Code

FI-90220

Country

Finland

Facility Name

Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor)

City

Pori

ZIP/Postal Code

FI-28100

Country

Finland

Facility Name

Seinäjoki Vaccine Research Clinic, Keskuskatu 6

City

Seinäjoki

ZIP/Postal Code

FI-60100

Country

Finland

Facility Name

Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor)

City

Tampere

ZIP/Postal Code

FI-33100

Country

Finland

Facility Name

Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor

City

Tapiontori 1, Espoo

ZIP/Postal Code

FI-02100

Country

Finland

Facility Name

Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor)

City

Turku

ZIP/Postal Code

FI-20520

Country

Finland

Facility Name

Vantaa East, Vaccine Research Clinic, Asematie 11 a 16

City

Vantaa

ZIP/Postal Code

FI-01300

Country

Finland

Facility Name

Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor

City

Vantaa

ZIP/Postal Code

FI-01600

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

26091244

Citation

Vesikari T, Forsten 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.

Results Reference

result

Learn more about this trial

Immunogenicity and Safety of V70P5 Revaccination Subjects

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