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NCT01210898

Immunogenicity and Safety of V70P5 Revaccination Subjects

NCT ID: NCT01210898

Last Updated: 2016-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Influenza

Keywords

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Influenza Trivalent Adjuvanted Vaccine Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 2

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 3

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 4

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 5

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 6

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 7

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 8

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 9

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 10

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 11

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 12

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Group 13

Group Type EXPERIMENTAL

Adjuvanted seasonal influenza vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Adjuvanted seasonal influenza vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Months

Maximum Eligible Age

96 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Biokatu 10, Tampere, , Finland

Site Status

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

Helsinki, , Finland

Site Status

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

Helsinki, , Finland

Site Status

Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17

Järvenpää, , Finland

Site Status

Kokkola Vaccine Research Clinic, Rantakatu 7

Kokkola, , Finland

Site Status

Kotka Vaccine Research Clinic, Karjalantie 10-12

Kotka, , Finland

Site Status

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

Kuopio, , Finland

Site Status

Lahti Vaccine Research Clinic, Vesijärvenkatu 74

Lahti, , Finland

Site Status

Oulu Vaccine Research Clinic, Kiviharjunlenkki 6

Oulu, , Finland

Site Status

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

Pori, , Finland

Site Status

Seinäjoki Vaccine Research Clinic, Keskuskatu 6

Seinäjoki, , Finland

Site Status

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

Tampere, , Finland

Site Status

Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor

Tapiontori 1, Espoo, , Finland

Site Status

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

Turku, , Finland

Site Status

Vantaa East, Vaccine Research Clinic, Asematie 11 a 16

Vantaa, , Finland

Site Status

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

Vantaa, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type RESULT

PMID: 26091244 (View on PubMed)

Other Identifiers

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2010-021644-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V70P5E1

Identifier Type: -

Identifier Source: org_study_id