InfluenzaPhase 2NCT00958126

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

A Phase 2 study testing CSL425 in people with Influenza, run by Seqirus at 11 sites in United States.

Completed

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

Trial summary

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CSL425
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,313 participants
Where: 11 sitesUnited States
Study dates: Aug 2009to Apr 2010
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female aged 18 and older, inclusive, at the time of providing informed consent.
Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Who cannot join

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Study Site
Austin, Texas, 78705
Study Site
Baltimore, Maryland, 21205
Study Site
Fort Worth, Texas, 76135
Study Site
Huntsville, Alabama, 35802
Study Site
Melbourne, Florida, 32935
Study Site
Metairie, Louisiana, 70006
Study Site
Peoria, Illinois, 61602
Study Site
Rockville, Maryland, 20850
Study Site
Salt Lake City, Utah, 84124
Study Site
San Diego, California, 92108
Study Site
South Bend, Indiana, 46601

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Conditions: Influenza
Being tested: CSL425, Placebo
Medical subject headings: Influenza, Human

What participants receive

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

CSL425Biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.
CSL425Biological
CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
PlaceboBiological
Vaccine diluent, thimerosal 0.01% (weight/volume).

Study groups in NCT00958126
Study group	Role	What they receive
CSL425 (7.5 mcg)	Experimental	7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 Receives: Biological: CSL425
CSL425 (15 mcg)	Experimental	15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. Receives: Biological: CSL425
CSL425 (30 mcg)	Experimental	30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21 Receives: Biological: CSL425
Placebo	Placebo comparator	Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21. Receives: Biological: Placebo

What is being measured

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

Seroconversion Rate 21 Days After the First Vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Measured: 21 days after the first vaccination
Seroconversion Rate 21 Days After the Second Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Measured: 21 days after the second vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
Measured: 21 days after the first vaccination
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
Measured: 21 days after the second vaccination

Secondary outcomes (4)

Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.
Measured: During the 7 days after the first vaccination
Duration of Solicited Local Adverse Events After the First Vaccination
Measured: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).
Measured: Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Unsolicited adverse event (UAE) grading:
Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.
Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Measured: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Timeline

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

Aug 2009Apr 2010

First posted13 Aug 2009 (estimated)
Study startAug 2009
Primary completionNov 2009
Study completionApr 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 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,313 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958126
Sponsor's protocol ID: CSLCT-CAL-09-61
Status last verified: Oct 2017
First submitted: 12 Aug 2009
Last updated: 21 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.
PubMed 20874515

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 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older
ClinicalTrials.gov ID: NCT00958126
Acronym / sponsor ID: CSLCT-CAL-09-61
Conditions: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,313 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Nov 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 13 Aug 2009 (estimated)
Results: Posted 3 Oct 2012

Clinical summary

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

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
CSL425 (7.5 mcg)	Experimental	Biological: CSL4257.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
CSL425 (15 mcg)	Experimental	Biological: CSL42515 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg)	Experimental	Biological: CSL42530 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
Placebo	Placebo comparator	Biological: PlaceboVaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Male or female aged 18 and older, inclusive, at the time of providing informed consent.
Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Key exclusion criteria (1 listed)

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

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
CSL425CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.	Biological	CSL425 (7.5 mcg)
CSL425CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).	Biological	CSL425 (15 mcg), CSL425 (30 mcg)
PlaceboVaccine diluent, thimerosal 0.01% (weight/volume).	Biological	Placebo

Primary outcome

Seroconversion Rate 21 Days After the First Vaccination
Time frame: 21 days after the first vaccination
Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Seroconversion Rate 21 Days After the Second Vaccination
Time frame: 21 days after the second vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination
Time frame: 21 days after the first vaccination
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination
Time frame: 21 days after the second vaccination

4 secondary outcomes

Frequency and Intensity of Solicited Adverse Events After the First Vaccination
Time frame: During the 7 days after the first vaccination
Duration of Solicited Local Adverse Events After the First Vaccination
Time frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)
Time frame: Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Time frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Results and safety

Results posted to the registry on 3 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo, Adults	49	48
CSL425 (7.5 mcg), Adults	205	196
CSL425 (15 Mcg), Adults	201	191
CSL425 (30 Mcg), Adults	203	192
Placebo, Older Adults	50	50
CSL425 (7.5 Mcg), Older Adults	203	202
CSL425 (15 Mcg), Older Adults	200	199
CSL425 (30 Mcg), Older Adults	202	202

Primary outcome: Seroconversion Rate 21 Days After the First Vaccination

Time frame: 21 days after the first vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo, Adults n = 48	CSL425 (7.5 mcg), Adults n = 200	CSL425 (15 Mcg), Adults n = 195	CSL425 (30 Mcg), Adults n = 199	Placebo, Older Adults n = 48	CSL425 (7.5 Mcg), Older Adults n = 201	CSL425 (15 Mcg), Older Adults n = 197	CSL425 (30 Mcg), Older Adults n = 200
Value	0 (0.0 to 7.4)	82 (76.0 to 87.1)	88.2 (82.8 to 92.4)	94.5 (90.3 to 97.2)	2.1 (0.1 to 11.1)	51.2 (44.1 to 58.3)	58.9 (51.7 to 65.8)	73.0 (66.3 to 79.0)

Population analysed: The Evaluable Population (for the first vaccination) comprised all randomized participants who received the first study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Primary outcome: Seroconversion Rate 21 Days After the Second Vaccination

Time frame: 21 days after the second vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo, Adults n = 48	CSL425 (7.5 mcg), Adults n = 196	CSL425 (15 Mcg), Adults n = 191	CSL425 (30 Mcg), Adults n = 193	Placebo, Older Adults n = 48	CSL425 (7.5 Mcg), Older Adults n = 200	CSL425 (15 Mcg), Older Adults n = 196	CSL425 (30 Mcg), Older Adults n = 198
Value	6.3 (1.3 to 17.2)	83.2 (77.2 to 88.1)	91.1 (86.1 to 94.7)	95.9 (92.0 to 98.2)	8.3 (2.3 to 20.0)	59.5 (52.3 to 66.4)	67.3 (60.3 to 73.9)	75.3 (68.6 to 81.1)

Population analysed: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccine; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

Primary outcome: Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination

Time frame: 21 days after the first vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo, Adults n = 48	CSL425 (7.5 mcg), Adults n = 200	CSL425 (15 Mcg), Adults n = 195	CSL425 (30 Mcg), Adults n = 199	Placebo, Older Adults n = 48	CSL425 (7.5 Mcg), Older Adults n = 201	CSL425 (15 Mcg), Older Adults n = 197	CSL425 (30 Mcg), Older Adults n = 200
Value	22.9 (12.0 to 37.3)	97.0 (93.6 to 98.9)	96.4 (92.7 to 98.5)	99.5 (97.2 to 100.0)	39.6 (25.8 to 54.7)	92.0 (87.4 to 95.4)	90.9 (85.9 to 94.5)	94.0 (89.8 to 96.9)

Primary outcome: Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination

Time frame: 21 days after the second vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Placebo, Adults n = 48	CSL425 (7.5 mcg), Adults n = 196	CSL425 (15 Mcg), Adults n = 191	CSL425 (30 Mcg), Adults n = 193	Placebo, Older Adults n = 48	CSL425 (7.5 Mcg), Older Adults n = 200	CSL425 (15 Mcg), Older Adults n = 196	CSL425 (30 Mcg), Older Adults n = 198
Value	29.2 (17.0 to 44.1)	98.5 (95.6 to 99.7)	99.5 (97.1 to 100.0)	99.5 (97.1 to 100.0)	35.4 (22.2 to 50.5)	96.0 (92.3 to 98.3)	93.4 (88.9 to 96.4)	94.9 (90.9 to 97.6)

Population analysed: The Evaluable Population (for the second vaccination) comprised all randomized participants who received the second study vaccination; provided both pre- and post-vaccination blood samples; were not excluded from analyses (eg, for the use of a prohibited medication or a laboratory-confirmed 2009 H1N1 infection between Visit 1 and Visit 3).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: For SAEs: up to 180 days after the last vaccination. For unsolicited adverse events: 21 days after the first study vaccination, up to 180 days after the the last vaccination (for AESI and NOCI).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo, Adults	0 of 49 (0%)	12 of 49 (24.5%)	Not reported
CSL425 (7.5 mcg), Adults	6 of 204 (2.9%)	27 of 204 (13.2%)	Not reported
CSL425 (15 Mcg), Adults	4 of 201 (2%)	25 of 201 (12.4%)	Not reported
CSL425 (30 Mcg), Adults	3 of 203 (1.5%)	27 of 203 (13.3%)	Not reported
Placebo, Older Adults	3 of 50 (6%)	5 of 50 (10%)	Not reported
CSL425 (7.5 Mcg), Older Adults	9 of 203 (4.4%)	20 of 203 (9.9%)	Not reported
CSL425 (15 Mcg), Older Adults	6 of 200 (3%)	23 of 200 (11.5%)	Not reported
CSL425 (30 Mcg), Older Adults	9 of 202 (4.5%)	18 of 202 (8.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20874515Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.

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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.

Director, Vaccines Clinical Development study director

Seqirus

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CSL425 in people with Influenza, run by Seqirus at 11 sites in United States.

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 2 inclusion and 1 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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. Some participants in this study may receive a placebo. 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 3 Oct 2012). 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?

Seroconversion Rate 21 Days After the First Vaccination (time frame: 21 days after the first vaccination). The study lists 4 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 NCT00958126, 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 21 Nov 2017.