Immunogenicity and Safety of V70P5 Revaccination Subjects

NCT01210898 | Completed Phase 3

• 2 other identifiers: V70P5E12010-021644-18
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 16

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.

Conditions

Influenza

Keywords

Influenza; Trivalent; Adjuvanted; Vaccine; Children

Outcome Measures

Primary Outcomes (4)

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

  22 days post vaccination

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

  22 days post vaccination

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

  22 days post vaccination

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

  22 days post vaccination

Secondary Outcomes (2)

• Primary immunogenicity outcomes as per CBER criteria

  Day 22

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

  Day 22

Study Arms (13)

Group 1

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 2

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 3

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 4

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 5

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 6

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 7

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 8

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 9

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 10

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 11

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 12

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Group 13

EXPERIMENTAL

Biological: Adjuvanted seasonal influenza vaccine

Interventions

Adjuvanted seasonal influenza vaccine BIOLOGICAL

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

Group 1; Group 10; Group 11; Group 12; Group 13; Group 2; Group 3; Group 4; Group 5; Group 6; Group 7; Group 8; Group 9

Eligibility Criteria

• Age: 18 Months - 96 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy male or female children that have previously participated in the V70P5 study in Finland.

You may not qualify if:

• Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (16)

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

Biokatu 10, Tampere, FI-33520, Finland

Location

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

Helsinki, FI-00100, Finland

Location

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

Helsinki, FI-00930, Finland

Location

Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17

Jarvenpaa, FI-04400, Finland

Location

Kokkola Vaccine Research Clinic, Rantakatu 7

Kokkola, FI-67100, Finland

Location

Kotka Vaccine Research Clinic, Karjalantie 10-12

Kotka, FI-48600, Finland

Location

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

Kuopio, 70211, Finland

Location

Lahti Vaccine Research Clinic, Vesijärvenkatu 74

Lahti, FI-15140, Finland

Location

Oulu Vaccine Research Clinic, Kiviharjunlenkki 6

Oulu, FI-90220, Finland

Location

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

Pori, FI-28100, Finland

Location

Seinäjoki Vaccine Research Clinic, Keskuskatu 6

Seinäjoki, FI-60100, Finland

Location

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

Tampere, FI-33100, Finland

Location

Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor

Tapiontori 1, Espoo, FI-02100, Finland

Location

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

Turku, FI-20520, Finland

Location

Vantaa East, Vaccine Research Clinic, Asematie 11 a 16

Vantaa, FI-01300, Finland

Location

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

Vantaa, FI-01600, Finland

Location

Related Publications (1)

• 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.

  PMID: 26091244 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: September 29, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 1, 2016

Record last verified: 2012-01

Locations

FI (16)