NCT01342796

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
9.2 years until next milestone

Results Posted

Study results publicly available

April 19, 2021

Completed
Last Updated

April 19, 2021

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

April 26, 2011

Results QC Date

June 5, 2018

Last Update Submit

April 14, 2021

Conditions

Seasonal InfluenzaInfluenzaInfluenza Due to Unspecified Influenza VirusHuman Influenza

Keywords

Cell mediated immunitycell mediated immune responseChildrenadjuvanted

Outcome Measures

Primary Outcomes (2)

  • Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.

    The CMI responses were determined by intracellular staining/Fluorescence-Activated Cell Sorting(ICS/FACS) after in-vitro restimulation of PBMC with vaccine antigens on day 0 and day 50.

    Day 1, Day 50

  • Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV

    The number of subjects reporting unsolicited AEs between Day 1 and the study termination i.e., Day 50, after receiving two doses of aTIV and TIV. Data are reported based on the Safety Set.

    Day 1 to Day 50 post vaccination

Secondary Outcomes (3)

  • Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer

    Day 50

  • Geometric Mean Ratios (GMR)

    Day 50/Day 1

  • Percentage of Subjects With HI Titers >1:40

    Day 50

Study Arms (2)

Arm 1

EXPERIMENTAL
Biological: MF59C.1-adjuvanted subunit influenza vaccine

Arm 2

ACTIVE COMPARATOR
Biological: Sub unit, Inactivated, Influenza vaccine

Interventions

MF59C.1-adjuvanted subunit influenza vaccineBIOLOGICAL

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Arm 1
Sub unit, Inactivated, Influenza vaccineBIOLOGICAL

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Arm 2

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Site 21: GZA campus Sint Vincentius

Antwerp, 2018, Belgium

Location

Site 22: Kinderartsenpraktijk

Hasselt, 3500, Belgium

Location

Related Publications (1)

  • Zedda L, Forleo-Neto E, Vertruyen A, Raes M, Marchant A, Jansen W, Clouting H, Arora A, Beatty ME, Galli G, Del Giudice G, Castellino F. Dissecting the immune response to MF59-adjuvanted and nonadjuvanted seasonal influenza vaccines in children less than three years of age. Pediatr Infect Dis J. 2015 Jan;34(1):73-8. doi: 10.1097/INF.0000000000000465.

    PMID: 25037034DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
Novartis.email@novartis.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

April 27, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

April 19, 2021

Results First Posted

April 19, 2021

Record last verified: 2019-02

Locations

BE(2)