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

Influenza Clinical Trial

Official title:

A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01342796
• Other study ID #: V70_34
• Secondary ID: 2010-023791-63
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Human Influenza
• Influenza
• Influenza Due to Unspecified Influenza Virus
• Influenza, Human
• Seasonal Influenza

Intervention

Biological:
• MF59C.1-adjuvanted subunit influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
• Sub unit, Inactivated, Influenza vaccine
2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Locations

Country	Name	City	State
Belgium	Site 21: GZA campus Sint Vincentius	Antwerpen
Belgium	Site 22: Kinderartsenpraktijk	Hasselt

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer	To evaluate the immune responses by seroconversion of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains.; Criteron: The proportion of subjects achieving seroconversion or significant increase in HI titer should be > 40%.	Day 50
Secondary	Geometric Mean Ratios (GMR)	To evaluate the immune responses by mean geometric increase (GMR) of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains.; Criterion: Mean geometric increase (GMR) should be > 2.5.	Day 50/Day 1
Secondary	Percentage of Subjects With HI Titers >1:40	To evaluate the immune responses by proportion of subjects with HI titers >1:40 of aTIV or TIV according to CHMP criteria for seasonal influenza vaccines as determined by hemagglutination inhibition (HI) test on plasma from previously unvaccinated healthy children aged 6 to < 36 months for all three strains.; Criterion: The proportion of subjects with HI titers >1:40 should be > 70%	Day 50