Seasonal InfluenzaPhase 2NCT01342796

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

A Phase 2 study testing MF59C.1-adjuvanted subunit influenza vaccine and Sub unit, Inactivated, Influenza vaccine in people with Seasonal Influenza and Influenza, run by Novartis Vaccines at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 6 to 36 monthsHealthy volunteers can take part
Conditions the study is for: Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus
What is being tested?: MF59C.1-adjuvanted subunit influenza vaccine and Sub unit, Inactivated, Influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 2 sitesBelgium
Study dates: May 2011to Feb 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 36 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

Belgium2 sites

Site 21: GZA campus Sint Vincentius
Antwerp, 2018
Site 22: Kinderartsenpraktijk
Hasselt, 3500

Other trials in Belgium

About this study

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

Conditions: Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Human Influenza
Being tested: MF59C.1-adjuvanted subunit influenza vaccine, Sub unit, Inactivated, Influenza vaccine
Keywords: Cell mediated immunity, cell mediated immune response, Children, adjuvanted
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01342796
Study group	Role	What they receive
Arm 1	Experimental	Not described Receives: Biological: MF59C.1-adjuvanted subunit influenza vaccine
Arm 2	Active comparator	Not described Receives: Biological: Sub unit, Inactivated, Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Day 1 to Day 50 post vaccination

Secondary outcomes (3)

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%.
Measured: Day 50
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.
Measured: Day 50/Day 1
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%
Measured: Day 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Feb 2012

First posted27 Apr 2011 (estimated)
Study startMay 2011
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01342796
Sponsor's protocol ID: V70_34
Other IDs: 2010-023791-63
Status last verified: Feb 2019
First submitted: 26 Apr 2011
Last updated: 19 Apr 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25037034

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Seasonal Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01342796
Acronym / sponsor ID: V70_34
Conditions: Seasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Human Influenza
Keywords: Cell mediated immunity, cell mediated immune response, Children, adjuvanted
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 27 Apr 2011 (estimated)
Results: Posted 19 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Biological: MF59C.1-adjuvanted subunit influenza vaccine
Arm 2	Active comparator	Biological: Sub unit, Inactivated, Influenza vaccine

Who may qualify

Ages: 6 to 36 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MF59C.1-adjuvanted subunit influenza vaccine2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm	Biological	Arm 1
Sub unit, Inactivated, Influenza vaccine2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm	Biological	Arm 2

Primary outcome

Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination.
Time frame: Day 1, Day 50
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.
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV
Time frame: Day 1 to Day 50 post vaccination
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.

3 secondary outcomes

Percentage of Subjects Achieving Seroconversion or Significant Increase in HI Titer
Time frame: Day 50
Geometric Mean Ratios (GMR)
Time frame: Day 50/Day 1
Percentage of Subjects With HI Titers >1:40
Time frame: Day 50

Results and safety

Results posted to the registry on 19 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
aTIV Group	43	40
TIV Group	41	38

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

Time frame: Day 1, Day 50. Mean (95% Confidence Interval). Unit: Cells per Million Total Cells

Measure	aTIV Group n = 25	TIV Group n = 31
Any Cytokine - A/H1N1, Day 1	631 (477 to 784)	655 (503 to 806)
Any Cytokine - A/H1N1, Day 50	1560 (1244 to 1876)	1137 (826 to 1449)
Any Cytokine - A/H3N2, Day 1	503 (346 to 660)	462 (322 to 602)
Any Cytokine - A/H3N2, Day 50	1328 (1105 to 1550)	671 (474 to 869)
Any Cytokine - B/Brisbane, (N=19, 24), Day 1	648 (452 to 844)	753 (579 to 927)
Any Cytokine - B/Brisbane, Day 50	2369 (1940 to 2798)	1062 (677 to 1446)
Any cytokine - B/Florida, Day 1	605 (215 to 996)	749 (483 to 1015)
Any cytokine - B/Florida, Day 50	1607 (1113 to 2100)	996 (662 to 1330)

Population analysed: Per Protocol Set

Primary outcome: Number of Subjects Reporting Unsolicited Adverse Events After Receiving Two Doses of aTIV and TIV

Time frame: Day 1 to Day 50 post vaccination. Count of participants. Unit: Participants

Measure	aTIV Group n = 43	TIV Group n = 41
Any Adverse Event (AE)	20	18
At least possibly related AE	1	3
Any SAE	0	2
At least possibly related SAE	0	0
AE leading to discontinuation	0	0
Death	0	0

Population analysed: All subjects in the Exposed Set (all enrolled subjects who actually received a study vaccine) who provided post-baseline safety data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All solicited AEs and unsolicited AEs were collected from Day 1 to Day 7; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 50.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
aTIV (6 to <36 Months)	0 of 43 (0%)	37 of 43 (86%)	Not reported
TIV (6 to <36 Months)	2 of 41 (4.9%)	29 of 41 (70.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25037034Zedda 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell Mediated Immune (CMI) Responses After In-vitro Restimulation Of Peripheral Blood Mononuclear Cells (PBMC) Following Vaccination. (time frame: Day 1, Day 50). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01342796, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.