Immunogenicity and Safety of V70P5 Revaccination Subjects

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01210898

Enrollment

197

Registered

2010-09-29

Start date

2010-09-30

Completion date

2011-12-31

Last updated

2016-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Trivalent, Adjuvanted, Vaccine, Children

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.

Interventions

BIOLOGICALAdjuvanted seasonal influenza vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Months to 96 Months

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received	22 days post vaccination
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

Secondary

Measure	Time frame
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026