Novel 2009 Influenza H1N1Phase 3NCT00973700

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

A Phase 3 study testing MF59-eH1N1_f and eH1N1_f in people with Novel 2009 Influenza H1N1, run by Novartis Vaccines at 1 site in Costa Rica.

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 will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults. Read more about this study

Who is it for?: Ages 3 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Novel 2009 Influenza H1N1
What is being tested?: MF59-eH1N1_f and eH1N1_f
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 784 participants
Where: 1 siteCosta Rica
Study dates: Aug 2009to Oct 2010
Phase: Phase 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 3 to 64 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Children, adolescents, and adults 3 to 64 years 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

1 site in 1 country.

Costa Rica1 site

Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
San José

Other trials in Costa Rica

About this study

Official title: A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

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

What participants receive

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

MF59-eH1N1_fBiological
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
eH1N1_fBiological
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Study groups in NCT00973700
Study group	Role	What they receive
2x7.5adj	Experimental	Two doses of MF59 adjuvanted (adj) A/H1N1 Receives: Biological: MF59-eH1N1_f
7.5adj_1_8	Experimental	MF59 adjuvanted (adj) A/H1N1 on days 1 and 8 Receives: Biological: MF59-eH1N1_f
7.5adj_1_22	Experimental	MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22 Receives: Biological: MF59-eH1N1_f
15_1_22	Experimental	A/H1N1 on study days 1 and 22 Receives: Biological: eH1N1_f
2x15_1_22	Experimental	Two doses of A/H1N1 (one in each arm) on study days 1 and 22 Receives: Biological: eH1N1_f

What is being measured

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

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
Measured: Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Analyses were performed on the Per-Protocol set (PPS).
Measured: Day 1 to day 387

Secondary outcomes (8)

Age Distribution at Baseline
Measured: Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
Measured: Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the the per-protocol set (PPS).
Measured: Day 1 to day 387
HI GMR, in Adults 18 to 64 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the Per-Protocol Set (PPS).
Measured: Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the per-protocol set (PPS).
Measured: 7 days and 21 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).
Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
Measured: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).
Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.
Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
Measured: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).
Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.
The analyses were performed on the safety set.
Measured: 7 days after each vaccination

Timeline

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

Aug 2009Oct 2010

First posted9 Sep 2009 (estimated)
Study startAug 2009
Primary completionOct 2009
Study completionOct 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Novel 2009 Influenza H1N1Studies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 784 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00973700
Sponsor's protocol ID: V112_04
Status last verified: Oct 2015
First submitted: 2 Sep 2009
Last updated: 2 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.
PubMed 21285531

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
ClinicalTrials.gov ID: NCT00973700
Acronym / sponsor ID: V112_04
Conditions: Novel 2009 Influenza H1N1
Keywords: Swine Flu, Flu, Vaccine, Adjuvant
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 784 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Oct 2009 (actual)
Study completion: Oct 2010 (actual)
First posted: 9 Sep 2009 (estimated)
Results: Posted 23 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 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
2x7.5adj	Experimental	Biological: MF59-eH1N1_fTwo doses of MF59 adjuvanted (adj) A/H1N1
7.5adj_1_8	Experimental	Biological: MF59-eH1N1_fMF59 adjuvanted (adj) A/H1N1 on days 1 and 8
7.5adj_1_22	Experimental	Biological: MF59-eH1N1_fMF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
15_1_22	Experimental	Biological: eH1N1_fA/H1N1 on study days 1 and 22
2x15_1_22	Experimental	Biological: eH1N1_fTwo doses of A/H1N1 (one in each arm) on study days 1 and 22

Who may qualify

Ages: 3 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Children, adolescents, and adults 3 to 64 years 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_fMF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal	Biological	2x7.5adj, 7.5adj_1_22, 7.5adj_1_8
eH1N1_fUnadjuvanted egg-derived A/H1N1 with traces of Thiomersal	Biological	15_1_22, 2x15_1_22

Primary outcome

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Time frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Time frame: Day 1 to day 387
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer. Analyses were performed on the Per-Protocol set (PPS).

8 secondary outcomes

Age Distribution at Baseline
Time frame: Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Time frame: Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Time frame: Day 1 to day 387
HI GMR, in Adults 18 to 64 Years
Time frame: Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Time frame: 7 days and 21 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Time frame: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Time frame: 7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Time frame: 7 days after each vaccination

Results and safety

Results posted to the registry on 23 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
2x7.5adj	56	49
7.5adj_1_8	56	54
7.5adj_1_22	168	158
15_1_22	336	318
2x15_1_22	168	158

Primary outcome: Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age

Time frame: Day 1 to day 387. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	15_1_22 n = 149
HI Titer ≥40 on day 1	26 (19 to 33)
HI Titer ≥40 on day 22	83 (76 to 89)
HI Titer ≥40 on day 29	95 (91 to 98)
HI Titer ≥40 on day 43	92 (86 to 96)
HI Titer ≥40 on day 217 (N=129)	88 (81 to 93)
HI Titer ≥40 on day 387 (N=136)	80 (72 to 86)
Seroconversion on day 22	79 (71 to 85)
Seroconversion on day 29	92 (86 to 96)

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

Primary outcome: Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age

Time frame: Day 1 to day 387. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	15_1_22 n = 132
HI Titer ≥40 on day 1	18 (12 to 26)
HI Titer ≥40 on day 8	93 (87 to 97)
HI Titer ≥40 on day 15	99 (96 to 100)
HI Titer ≥40 on day 22	98 (95 to 100)
HI Titer ≥40 on day 29	99 (96 to 100)
HI Titer ≥40 on Day 43	100 (97 to 100)
HI Titer ≥40 on Day 217 (N=111)	91 (84 to 96)
HI Titer ≥40 on Day 387 (N=120)	84 (76 to 90)

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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2x7.5adj (18 to 64 Yrs)	2 of 54 (3.7%)	49 of 54 (90.7%)	Not reported
7.5adj_1_8 (18 to 64 Yrs)	0 of 56 (0%)	41 of 56 (73.2%)	Not reported
7.5adj_1_22 (18-64 Yrs)	1 of 56 (1.8%)	48 of 56 (85.7%)	Not reported
15_1_22 (18 to 64 Yrs)	4 of 159 (2.5%)	119 of 159 (74.8%)	Not reported
2x15_1_22 (18 to 64 Yrs)	1 of 54 (1.9%)	35 of 54 (64.8%)	Not reported
7.5adj_1_22 (9 to 17 Yrs)	1 of 53 (1.9%)	46 of 53 (86.8%)	Not reported
15_1_22 (9 to 17 Yrs)	1 of 84 (1.2%)	67 of 84 (79.8%)	Not reported
2x15_1_22 (9 to 17 Yrs)	0 of 57 (0%)	43 of 57 (75.4%)	Not reported
7.5adj_1_22 (3 to <9 Yrs)	2 of 55 (3.6%)	40 of 55 (72.7%)	Not reported
15_1_22 (3 to <9 Yrs)	0 of 84 (0%)	61 of 84 (72.6%)	Not reported
2x15_1_22 (3 to <9 Yrs)	0 of 54 (0%)	41 of 54 (75.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21285531Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.

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 study director

Novartis Vaccines

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MF59-eH1N1_f and eH1N1_f in people with Novel 2009 Influenza H1N1, run by Novartis Vaccines at 1 site in Costa Rica.

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 2 Dec 2015. 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 Costa Rica. 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 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 23 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?

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age (time frame: Day 1 to day 387). 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 NCT00973700, 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 2 Dec 2015.