Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

Novartis

Status and phase: Completed; Phase 2

Conditions: Human Influenza; Influenza; Seasonal Influenza; Influenza Due to Unspecified Influenza Virus

Treatments: Biological: Sub unit, Inactivated, Influenza vaccine; Biological: MF59C.1-adjuvanted subunit influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342796

V70_34

2010-023791-63 (EudraCT Number)

Details and patient eligibility

About

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to <36 months.

Enrollment: 84 patients

Sex: All

Ages: 6 to 36 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female previously unvaccinated healthy children aged 6 to <36 months.

Exclusion criteria

• Any known or suspected impairment of the immune system, any serious disease.
• Any subjects receiving licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study.
• Individuals who have had influenza vaccine or documented suspected influenza disease prior to day 1.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

84 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Biological: MF59C.1-adjuvanted subunit influenza vaccine

Arm 2

Active Comparator group

Treatment:

Biological: Sub unit, Inactivated, Influenza vaccine