Immunogenicity and Safety of V70P5 Revaccination Subjects

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Adjuvanted seasonal influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01210898

2010-021644-18 (EudraCT Number)

V70P5E1

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18 to 96 months old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

197 participants in 13 patient groups

Group 1

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 2

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 3

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 4

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 5

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 6

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 7

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 8

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 9

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 10

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 11

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 12

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine

Group 13

Experimental group

Treatment:

Biological: Adjuvanted seasonal influenza vaccine