InfluenzaPhase 2/3NCT00996307

Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

A Phase 2/3 study testing MF59-eH1N1_f in people with Influenza, run by Novartis Vaccines at 29 sites in 2 countries.

Completed

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

Trial summary

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children Read more about this study

Who is it for?: Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: MF59-eH1N1_f
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 654 participants
Where: 29 sitesin 2 countries
Study dates: Oct 2009to Dec 2010
Phase: Phase 2/3
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 35 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months

Who cannot join

History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
For additional entry criteria, please refer to protocol

Trial locations and contacts

29 sites in 2 countries.

Country

City, postcode or hospital

29 sites in 2 countries

United States28 sites

Study site
Bardstown, Kentucky, 40004
Study site
Bentonville, Arkansas, 72712
Study site
Canoga Park, California, 91306
Study site
Charleston, South Carolina, 29406
Study site
Charlottesville, Virginia, 22902
Study site
Dallas, Texas, 75230
Study site
Dayton, Ohio, 45406
Study site
Dinuba, California, 93618
Study site
Fargo, North Dakota, 58104
Study site
Fort Smith, Arkansas, 72903
Study site
Fresno, California, 93703
Study site
Houston, Texas, 77055
Study site
Huber Heights, Ohio, 45424
Study site
Lebanon, Tennessee, 37087
Study site
Long Beach, California, 90806
Study site
Los Angeles, California, 90015
Study site
Madera, California, 93637
Study site
New Albany, Indiana, 47150
Study site
Newton, Kansas, 67114
Study site
Oklahoma City, Oklahoma, 73103
Study site
Provo, Utah, 84604
Study site
South Jordan, Utah, 84095
Study site
Spartanburg, South Carolina, 29303
Study site
St. George, Utah, 84790
Study site
Torrance, California, 90503
Study site
West Jordan, Utah, 84088
Study site
Wichita, Kansas, 67207
Study site
Woburn, Massachusetts, 01801

Other trials in United States

Mexico1 site

Study site
Tlalpan, Mexico City, 14000

Other trials in Mexico

About this study

Official title: Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Conditions: Influenza
Being tested: MF59-eH1N1_f
Keywords: Swine Flu, Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza
Medical subject headings: Influenza, Human, Orthomyxoviridae Infections

What participants receive

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

MF59-eH1N1_fBiological
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
MF59-eH1N1_fBiological
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
MF59-eH1N1_fBiological
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
MF59-eH1N1_fBiological
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Study groups in NCT00996307
Study group	Role	What they receive
3.75_(50)MF59	Experimental	3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. Receives: Biological: MF59-eH1N1_f
7.5_(0)MF59	Experimental	7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. Receives: Biological: MF59-eH1N1_f
7.5_(50)MF59	Experimental	7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22. Receives: Biological: MF59-eH1N1_f
15_(0)MF59	Experimental	15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22. Receives: Biological: MF59-eH1N1_f

What is being measured

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

Antibody Responses After the First and Second Vaccinations
CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Measured: 21 days after each vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Measured: Day 1 to 7
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
Measured: Day 22 to 28

Secondary outcomes (6)

Immunogenicity Measurement by Geometric Mean Titers (GMT)
Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
Measured: 21 days after each vaccination
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Measured: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Measured: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
Measured: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
Measured: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Antibody Persistence by Geometric Mean Titers (GMT)
Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Measured: 6 months (Day 202) and 12 months (Day 387) after second vaccination

Timeline

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

Oct 2009Dec 2010

First posted16 Oct 2009 (estimated)
Study startOct 2009
Primary completionDec 2009
Study completionDec 2010

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.
Other trials for 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 654 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00996307
Sponsor's protocol ID: V112_06
Status last verified: Apr 2017
First submitted: 15 Oct 2009
Last updated: 30 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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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Study at a glance

From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
ClinicalTrials.gov ID: NCT00996307
Acronym / sponsor ID: V112_06
Conditions: Influenza
Keywords: Swine Flu, Flu, Vaccine, Children, Adjuvant, A/H1N1 2009 Influenza
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 654 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Oct 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2010 (actual)
First posted: 16 Oct 2009 (estimated)
Results: Posted 25 May 2011

Clinical summary

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

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
3.75_(50)MF59	Experimental	Biological: MF59-eH1N1_f3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5_(0)MF59	Experimental	Biological: MF59-eH1N1_f7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5_(50)MF59	Experimental	Biological: MF59-eH1N1_f7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
15_(0)MF59	Experimental	Biological: MF59-eH1N1_f15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

Who may qualify

Ages: 6 to 35 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months

Key exclusion criteria (5 listed)

History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
For additional entry criteria, please refer to protocol

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-eH1N1_f3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.	Biological	3.75_(50)MF59
MF59-eH1N1_f7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.	Biological	7.5_(0)MF59
MF59-eH1N1_f15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.	Biological	15_(0)MF59
MF59-eH1N1_f7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.	Biological	7.5_(50)MF59

Primary outcome

Antibody Responses After the First and Second Vaccinations
Time frame: 21 days after each vaccination
CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Time frame: Day 1 to 7
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Time frame: Day 22 to 28
Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.

6 secondary outcomes

Immunogenicity Measurement by Geometric Mean Titers (GMT)
Time frame: 21 days after each vaccination
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Antibody Response Based on Baseline Seropositivity
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
Antibody Persistence by Geometric Mean Titers (GMT)
Time frame: 6 months (Day 202) and 12 months (Day 387) after second vaccination

Results and safety

Results posted to the registry on 25 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3.75_(50)MF59	164	144
7.5_(0)MF59	165	148
7.5_(50)MF59	160	146
15_(0)MF59	165	144

Primary outcome: Antibody Responses After the First and Second Vaccinations

Time frame: 21 days after each vaccination. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	3.75_(50)MF59 n = 129	7.5_(0)MF59 n = 124	7.5_(50)MF59 n = 126	15_(0)MF59 n = 129
HI titer ≥1:40 (Baseline)	19 (12 to 26)	9 (5 to 15)	15 (9 to 23)	19 (13 to 27)
HI titer ≥1:40 (Day 22)	79 (71 to 86)	37 (29 to 46)	86 (78 to 91)	50 (41 to 59)
Seroconversion Day 22	74 (65 to 81)	32 (24 to 41)	80 (72 to 87)	44 (35 to 53)
HI titer ≥1:40 (Day 43)	100 (97 to 100)	70 (61 to 78)	100 (97 to 100)	81 (74 to 88)
Seroconversion Day 43	98 (93 to 100)	68 (59 to 76)	98 (94 to 100)	76 (68 to 83)
HI titer ≥1:40 (Day 202;N=45,38,46,38)	96 (85 to 99)	50 (33 to 67)	100 (92 to 100)	55 (38 to 71)
Seroconversion Day 202;N=45,38,46,38)	89 (76 to 96)	50 (33 to 67)	91 (79 to 98)	39 (24 to 57)
HI titer ≥1:40 (Day 387;N=46,37,38,36)	85 (71 to 94)	27 (14 to 44)	84 (69 to 94)	36 (21 to 54)

Population analysed: The analysis was done on the per-protocol set (PPS).

Primary outcome: Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination

Time frame: Day 1 to 7. Number. Unit: Participants

Measure	3.75_(50)MF59 n = 161	7.5_(0)MF59 n = 161	7.5_(50)MF59 n = 161	15_(0)MF59 n = 163
Ecchymosis	0	0	0	0
Erythema	1	0	2	1
Swelling	6	9	4	6
Induration	8	8	13	8
Tenderness	49	42	53	42
Sleepiness	36	28	38	30
Diarrhea	32	28	37	25
Vomiting	13	10	12	10

Population analysed: The analysis was done on the safety set which included the five subjects who received wrong vaccination according to the randomization. These five subjects were excluded from PPS.

Primary outcome: Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination

Time frame: Day 22 to 28. Number. Unit: Participants

Measure	3.75_(50)MF59 n = 155	7.5_(0)MF59 n = 148	7.5_(50)MF59 n = 157	15_(0)MF59 n = 157
Ecchymosis	0	0	1	0
Erythema	1	1	4	1
Swelling	2	1	8	6
Induration	4	3	12	9
Tenderness	35	27	37	32
Sleepiness	28	21	20	17
Diarrhea	20	19	20	15
Vomiting	11	9	14	5

Population analysed: The analysis was done on the safety set. Almost all the subjects across the vaccine groups received their first and second vaccinations within the protocol-specified window. While all the enrolled subjects received their first vaccination, 3% to 7% of subjects across the vaccine groups did not receive their second vaccination.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire study period. Five subjects received wrong vaccination according to the randomization and were excluded from PPS but were included in the safety set.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3.75_(50)MF59	5 of 162 (3.1%)	144 of 162 (88.9%)	Not reported
7.5_(0)MF59	6 of 164 (3.7%)	152 of 164 (92.7%)	Not reported
7.5_(50)MF59	1 of 162 (0.6%)	141 of 162 (87%)	Not reported
15_(0)MF59	10 of 166 (6%)	142 of 166 (85.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Vaccines and Diagnostics study director

Novartis

29 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing MF59-eH1N1_f in people with Influenza, run by Novartis Vaccines at 29 sites in 2 countries.

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 5 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Mexico. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 May 2011). 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?

Antibody Responses After the First and Second Vaccinations (time frame: 21 days after each vaccination). The study lists 3 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 NCT00996307.

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 30 May 2017.