PandemicPhase 2NCT00481065

Immunogenicity, Safety and Tolerability of Prepandemic Influenza and Seasonal Influenza Vaccine in Adult Subjects

A Phase 2 study testing MF59-eH5N1, eTIV_a and MF59-eH5N1 + eTIV_a in people with Pandemic and Avian Influenza, run by Novartis at 1 site in Colombia.

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 evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Pandemic, Avian Influenza
What is being tested?: MF59-eH5N1, eTIV_a and MF59-eH5N1 + eTIV_a
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: 1 siteColombia
Study dates: Apr 2007to Dec 2008
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 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy subjects

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Study site
Bogotá

Other trials in Colombia

About this study

Official title: A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects

Conditions: Pandemic, Avian Influenza
Being tested: MF59-eH5N1, eTIV_a, MF59-eH5N1 + eTIV_a
Keywords: Bird flu, influenza vaccine, Seasonal influenza vaccine, Prepandemic vaccine
Medical subject headings: Influenza in Birds, Influenza, Human

What participants receive

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

MF59-eH5N1Biological
eTIV_aBiological
MF59-eH5N1 + eTIV_aBiological

Study groups in NCT00481065
Study group	Role	What they receive
Concomitant alone	Experimental	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382. Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
Concomitant +Mixed	Experimental	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
Concomitant +MF59-eH5N1	Experimental	1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
Mixed	Experimental	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
Mixed and mixed	Experimental	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
Mixed+MF59-eH5N1	Experimental	1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
MF59-eH5N1+eTIV_a	Experimental	1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a
eTIV_a+MF59-eH5N1	Experimental	1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382 Receives: Biological: MF59-eH5N1; Biological: eTIV_a; Biological: MF59-eH5N1 + eTIV_a

What is being measured

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

Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH).
Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Measured: 21 days after second and third vaccinations (day 43 and day 403)
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.
Measured: 21 days after second and third vaccinations (day 22 and day 43)
Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Measured: 21 days after second vaccination (day 43)
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Measured: 21 days after second and third vaccinations (day 43 and day 403)
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area.
Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Measured: 21 days after second and third vaccinations (day 43 and day 403)
Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Measured: 21 days after second vaccination (day 43)
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Measured: 21 days after second and third vaccinations (day 43 and day 403)
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Measured: 21 days after second and third vaccinations (day 43 and day 403)

Secondary outcomes (3)

Number of Subjects Reporting Local and Systemic Reactions by Vaccination
The evaluate the safety of the administration of two or three vaccinations of MF59-eH5N1 influenza vaccine, either given sequentially, concomitantly or mixed extemporaneously with seasonal eTIV_a influenza vaccine.
Measured: 21 days after second and third vaccinations (day 43 and day 403)
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Booster was given on day 382; seroconversion: negative pre-vaccination serum (HI titer <10, SRH area ≤ 4 mm^2)/positive post-vaccination titer (HI titer ≥10) or at least 50% increase in SRH area; Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
The number of subjects achieving seroconversion or significant increase and seroprotection were calculated at day 382.
Measured: 21 days after booster vaccination (day 403)
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
For each vaccine group, the least squares GMRs were calculated for the HI and SRH results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 382 for all time points for the booster dose.
Measured: 21 days after booster vaccination (day 403)

Timeline

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

Apr 2007Dec 2008

First posted1 Jun 2007 (estimated)
Study startApr 2007
Primary completionDec 2008
Study completionDec 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for PandemicStudies 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: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00481065
Sponsor's protocol ID: V87P5
Status last verified: Dec 2013
First submitted: 31 May 2007
Last updated: 3 Feb 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.
PubMed 21606530
Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.
PubMed 23536690

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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects
ClinicalTrials.gov ID: NCT00481065
Acronym / sponsor ID: V87P5
Conditions: Pandemic, Avian Influenza
Keywords: Bird flu, influenza vaccine, Seasonal influenza vaccine, Prepandemic vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Apr 2007
Primary completion: Dec 2008 (actual)
Study completion: Dec 2008 (actual)
First posted: 1 Jun 2007 (estimated)
Results: Posted 28 Feb 2013

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: None (open label)
Number of arms: 8

Arm	Type	Receives
Concomitant alone	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382.
Concomitant +Mixed	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Concomitant +MF59-eH5N1	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
Mixed and mixed	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
Mixed+MF59-eH5N1	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
MF59-eH5N1+eTIV_a	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
eTIV_a+MF59-eH5N1	Experimental	Biological: MF59-eH5N1, Biological: eTIV_a, Biological: MF59-eH5N1 + eTIV_a1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy subjects

Key exclusion criteria (0 listed)

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
MF59-eH5N1	Biological	Concomitant +MF59-eH5N1, Concomitant +Mixed, Concomitant alone, MF59-eH5N1+eTIV_a, Mixed, Mixed and mixed, Mixed+MF59-eH5N1, eTIV_a+MF59-eH5N1
eTIV_a	Biological	Concomitant +MF59-eH5N1, Concomitant +Mixed, Concomitant alone, MF59-eH5N1+eTIV_a, Mixed, Mixed and mixed, Mixed+MF59-eH5N1, eTIV_a+MF59-eH5N1
MF59-eH5N1 + eTIV_a	Biological	Concomitant +MF59-eH5N1, Concomitant +Mixed, Concomitant alone, MF59-eH5N1+eTIV_a, Mixed, Mixed and mixed, Mixed+MF59-eH5N1, eTIV_a+MF59-eH5N1

Primary outcome

Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
Seroconversion (serocon.) is defined as negative pre-vaccination serum (titer <10 for HI [Haemagglutination Inhibition], area ≤4 mm^2 for SRH [Single Radial Haemolysis]) / positive post-vaccination titer (titer ≥ 40 for HI, area ≥ 25 mm^2 for SRH). Significant increase in antibody titer is defined as at least a fourfold increase from non-negative pre-vaccination serum (HI ≥ 10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine
Time frame: 21 days after second and third vaccinations (day 22 and day 43)
Geometric mean Ratio (GMR) was calculated for the haemagglutination inhibition (HI), microneutralization (MN) and single-radial haemolysis (SRH) result as well as the associated 95% confidence intervals. GMR was calculated as 21 days after second and third vaccinations over day 1.
Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)
Time frame: 21 days after second vaccination (day 43)
seroconversion: negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain B)
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
seroconversion (serocon.): negative pre-vaccination serum (HI titer <10, SRH area =<4 mm^2)/positive post-vaccination titer (HI titer =>10) or at least 50% increase in the SRH area. Seroprotection is defined as a HI titer ≥40 and a SRH area ≥25 mm^2.
Geometric Mean Ratio After Two Doses of the Seasonal eTIV_a Influenza Vaccine (Strain H1N1)
Time frame: 21 days after second vaccination (day 43)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain H3N1)
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.
Geometric Mean Ratio After Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccine (Strain B)
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
For each vaccine group, the least squares GMRs were calculated for the haemagglutination inhibition (HI) results for each time point of the study, as well as the associated 95% confidence intervals. GMR was calculated over day 1.

3 secondary outcomes

Number of Subjects Reporting Local and Systemic Reactions by Vaccination
Time frame: 21 days after second and third vaccinations (day 43 and day 403)
Number of Subjects With Immunogenicity Results After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Time frame: 21 days after booster vaccination (day 403)
Geometric Mean Ratio After the Booster Vaccination Against the MF59-eH5N1 Influenza Vaccine Mixed Extemporaneously With the Seasonal eTIV_a Influenza Vaccine
Time frame: 21 days after booster vaccination (day 403)

Results and safety

Results posted to the registry on 28 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Concomitant Alone	51	29
Concomitant+Mixed	50	33
Concomitant+MF59-eH5N1	51	32
Mixed	52	37
Mixed + Mixed	51	28
Mixed+MF59-eH5N1	51	27
MF59-eH5N1+eTIV_a	50	34
eTIV_a+MF59-eH5N1	49	30

Primary outcome: Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine

Time frame: 21 days after second and third vaccinations (day 43 and day 403). Number. Unit: Subjects

Measure	Concomitant Alone n = 46	Concomitant+Mixed n = 48	Concomitant+MF59-eH5N1 n = 47	Mixed n = 50	Mixed + Mixed n = 49	Mixed+MF59-eH5N1 n = 48	MF59-eH5N1+eTIV_a n = 48	eTIV_a+MF59-eH5N1 n = 44
HI seroprot. (day1) N=46,48,47,50,49,48,48,44	0	1	0	2	1	0	0	0
HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	12 (14 to 41)	33 (54 to 81)	37 (66 to 91)	13 (15 to 41)	31 (49 to 78)	34 (56 to 83)	19 (26 to 56)	22 (35 to 67)
HI seroprot. (2nd vacc) N=46,48,46,49,48,48,47,43	12 (14 to 41)	34 (56 to 83)	37 (66 to 91)	14 (17 to 43)	32 (52 to 80)	34 (56 to 83)	19 (26 to 56)	22 (35 to 67)
HI serocon. (3rd vacc) N=23,24,36,39,31,20,32,32	17 (52 to 90)	15 (39 to 79)	26 (76 to 99)	19 (37 to 71)	16 (43 to 82)	13 (41 to 85)	24 (67 to 96)	16 (43 to 82)
HI seroprot. (3rd vacc) N=24,25,28,35,25,20,28,25	18 (53 to 90)	15 (39 to 79)	26 (76 to 99)	20 (39 to 74)	16 (43 to 82)	14 (46 to 88)	24 (67 to 96)	16 (43 to 82)
SRH seroprot. (day 1) N=46,48,47,50,49,48,48,44)	3	6	1	4	4	6	4	5
SRH serocon. (2nd vacc) N=46,48,46,50,46,48,47,42	14 (18 to 46)	38 (65 to 90)	43 (82 to 99)	11 (12 to 37)	31 (52 to 80)	38 (67 to 91)	23 (34 to 64)	25 (43 to 74)
SRH seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43	17 (23 to 52)	40 (70 to 93)	43 (82 to 99)	14 (16 to 42)	35 (58 to 85)	42 (75 to 95)	26 (40 to 70)	29 (51 to 81)

Population analysed: The analysis was done on the full analysis set (FAS).

Primary outcome: Geometric Mean Ratio After Two or Three Vaccinations of the MF59-eH5N1 Influenza Vaccine

Time frame: 21 days after second and third vaccinations (day 22 and day 43). Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Concomitant Alone n = 46	Concomitant+Mixed n = 48	Concomitant+MF59-eH5N1 n = 47	Mixed n = 50	Mixed + Mixed n = 49	Mixed+MF59-eH5N1 n = 48	MF59-eH5N1+eTIV_a n = 48	eTIV_a+MF59-eH5N1 n = 44
HI (2nd vacc) N= 46,48,46,49,48,48,47,43	2.11 (1.29 to 3.46)	12 (7.09 to 19)	23 (14 to 37)	2.16 (1.33 to 3.49)	9.52 (5.86 to 15)	14 (8.32 to 22)	2.96 (1.81 to 4.86)	5.34 (3.2 to 8.91)
HI (3rd vacc) N= 24,25,28,35,25,20,28,25	34 (15 to 76)	17 (7.82 to 37)	93 (44 to 197)	10 (5.36 to 20)	9.89 (4.5 to 22)	21 (8.56 to 49)	66 (31 to 139)	12 (5.53 to 26)
SRH (2nd vacc) N= 46,48,46,49,46,47,47,42	1.82 (1.35 to 2.44)	5.32 (3.98 to 7.09)	9.64 (7.17 to 13)	1.58 (1.19 to 2.11)	4.25 (3.16 to 5.71)	6.04 (4.5 to 8.11)	2.9 (2.16 to 3.88)	3.26 (2.39 to 4.44)
SRH (3rd vacc) N= 25,25,28,35,25,20,28,25	9.92 (6.73 to 15)	6.22 (4.25 to 9.12)	11 (7.47 to 16)	5.13 (3.69 to 7.13)	3.1 (2.07 to 4.65)	6.76 (4.33 to 11)	7.17 (4.95 to 10)	4.55 (3.08 to 6.74)
MN (2nd vacc) N= 46,48,47,50,49,48,48,44	2.12 (1.54 to 2.91)	7.64 (5.61 to 10)	13 (9.45 to 18)	2.15 (1.59 to 2.92)	6.79 (4.98 to 9.26)	11 (8.04 to 15)	3.86 (2.82 to 5.29)	3.49 (2.52 to 4.84)
MN (3rd vacc) N= 24,25,28,35,25,20,28,25	38 (23 to 64)	39 (23 to 64)	66 (40 to 109)	16 (10 to 25)	13 (8 to 23)	23 (13 to 41)	58 (36 to 95)	21 (12 to 35)

Primary outcome: Number of Subjects Who Responded to Two Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H1N1)

Time frame: 21 days after second vaccination (day 43). Number. Unit: Subjects

Measure	Concomitant Alone n = 46	Concomitant+Mixed n = 48	Concomitant+MF59-eH5N1 n = 47	Mixed n = 50	Mixed + Mixed n = 49	Mixed+MF59-eH5N1 n = 48	MF59-eH5N1+eTIV_a n = 48	eTIV_a+MF59-eH5N1 n = 44
HI seroprot. (day 1)	13	18	16	23	15	19	24	20
HI seroconversion N=46,48,46,49,48,48,47,43	33 (57 to 84)	35 (58 to 85)	36 (64 to 89)	29 (43 to 72)	37 (63 to 88)	37 (63 to 88)	29 (46 to 75)	31 (56 to 85)
HI seroprotection N=46,48,46,49,48,48,47,43	37 (66 to 91)	45 (83 to 99)	43 (82 to 99)	39 (64 to 88)	44 (80 to 98)	41 (72 to 94)	43 (80 to 98)	40 (81 to 99)

Population analysed: The analysis was done on the full analysis set (FAS).

Primary outcome: Number of Subjects Who Responded to Two or Three Vaccinations of the Seasonal eTIV_a Influenza Vaccines (Strain H3N2)

Time frame: 21 days after second and third vaccinations (day 43 and day 403). Number. Unit: Subjects

Measure	Concomitant Alone n = 46	Concomitant+Mixed n = 48	Concomitant+MF59-eH5N1 n = 47	Mixed n = 50	Mixed + Mixed n = 49	Mixed+MF59-eH5N1 n = 48	MF59-eH5N1+eTIV_a n = 48	eTIV_a+MF59-eH5N1 n = 44
HI seroprot. (day 1)	20	22	14	23	26	22	12	22
HI serocon. (2nd vacc) N=46,48,46,49,48,48,47,43	23 (35 to 65)	36 (60 to 86)	35 (61 to 87)	35 (55 to 82)	40 (70 to 93)	40 (70 to 93)	35 (60 to 86)	29 (51 to 81)
HI seroprot. (2nd vacc) N=46,48,46,50,48,48,47,43)	39 (71 to 94)	46 (86 to 99)	44 (85 to 99)	49 (89 to 100)	48 (93 to 100)	48 (93 to 100)	47 (92 to 100)	40 (81 to 99)
HI serocon. (3rd vacc) N=25,25,28,35,25,20,28,25	19 (55 to 91)	20 (59 to 93)	26 (76 to 99)	30 (70 to 95)	18 (51 to 88)	17 (62 to 97)	25 (72 to 98)	21 (64 to 95)
HI seroprot. (3rd vacc) N=30,33,36,39,31,29,34,32	18 (53 to 90)	15 (39 to 79)	26 (76 to 99)	20 (39 to 74)	16 (43 to 82)	14 (46 to 88)	86 (67 to 96)	64 (43 to 82)

Population analysed: The analysis was done on the full analysis set (FAS).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events and serious adverse events were collected for 20 months (the duration of the study).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Concomitant Alone	4 of 50 (8%)	38 of 50 (76%)	Not reported
Concomitant+Mixed	1 of 50 (2%)	42 of 50 (84%)	Not reported
Concomitant+MF59-eH5N1	2 of 51 (3.9%)	41 of 51 (80.4%)	Not reported
Mixed	3 of 51 (5.9%)	39 of 51 (76.5%)	Not reported
Mixed + Mixed	3 of 51 (5.9%)	42 of 51 (82.4%)	Not reported
Mixed+MF59-eH5N1	0 of 50 (0%)	43 of 50 (86%)	Not reported
MF59-eH5N1+eTIV_a	0 of 49 (0%)	37 of 49 (75.5%)	Not reported
eTIV_a+MF59-eH5N1	1 of 49 (2%)	38 of 49 (77.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21606530Lopez P, Caicedo Y, Sierra A, Tilman S, Banzhoff A, Clemens R. Combined, concurrent, and sequential administration of seasonal influenza and MF59-adjuvanted A/H5N1 vaccines: a phase II randomized, controlled trial of immunogenicity and safety in healthy adults. J Infect Dis. 2011 Jun 15;203(12):1719-28. doi: 10.1093/infdis/jir191.
Derived from this study: PubMed 23536690Lopez P, Caicedo Y, Sierra A, Tilman S, Clemens R, Banzhoff A. Combined administration of MF59-adjuvanted A/H5N1 prepandemic and seasonal influenza vaccines: long-term antibody persistence and robust booster responses 1 year after a one-dose priming schedule. Clin Vaccine Immunol. 2013 May;20(5):753-8. doi: 10.1128/CVI.00626-12. Epub 2013 Mar 27.

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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.

Novartis Drug Information Services +1 800 244 7668 study chair

Novartis

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MF59-eH5N1, eTIV_a and MF59-eH5N1 + eTIV_a in people with Pandemic and Avian Influenza, run by Novartis at 1 site in Colombia.

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 0 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. 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 28 Feb 2013). 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?

Number Subjects Who Responded to Two or Three Vaccinations of the MF59-H5N1 Influenza Vaccine (time frame: 21 days after second and third vaccinations (day 43 and day 403)). The study lists 8 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 NCT00481065, which also lists 2 linked publications.

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 3 Feb 2014.