InfluenzaPhase 2NCT00958243

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

A Phase 2 study testing CSL's 2009 H1N1 Influenza Vaccine (CSL425) in people with Influenza, run by Seqirus at 13 sites in United States.

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

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population. Read more about this study

Who is it for?: Ages 6 months to 9 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 473 participants
Where: 13 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 6 months to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Study site
Austin, Texas, 78705
Study site
Austintown, Ohio, 44515
Study site
Bardstown, Kentucky, 40004
Study site
Chandler, Arizona, 85224
Study site
Cincinnati, Ohio, 45246
Study site
Fort Worth, Texas, 76135
Study site
Houston, Texas, 77030
Study site
Latrobe, Pennsylvania, 15650
Study site
Melbourne, Florida, 32935
Study site
Metairie, Louisiana, 70006
Study site
Murray, Utah, 84107
Study site
Omaha, Nebraska, 68134
Study site
Pittsburgh, Pennsylvania, 15227

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 a Healthy Pediatric Population

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Conditions: Influenza
Being tested: CSL's 2009 H1N1 Influenza Vaccine (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.

CSL's 2009 H1N1 Influenza Vaccine (CSL425)Biological
0.5 mL intramuscular injection on Day 0 and Day 21
CSL's 2009 H1N1 Influenza Vaccine (CSL425)Biological
0.25 mL intramuscular injection on Day 0 and Day 21
PlaceboBiological
Placebo

Study groups in NCT00958243
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Biological: Placebo
CSL425 (7.5 mcg)	Experimental	7.5 mcg of hemagglutinin antigen per dose Receives: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
CSL425 (15 mcg)	Experimental	15 mcg of hemagglutinin antigen per dose Receives: Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

What is being measured

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

Seroconversion Rate 21 Days After First Study 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 first study vaccination
Seroconversion Rate 21 Days After Second Study 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 study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
Measured: 21 days after the first study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
Measured: 21 days after the second study vaccination

Secondary outcomes (6)

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.
Measured: During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Measured: During the 7 days after each study vaccination
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.
Measured: During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Measured: During the 7 days after each study vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
UAE grading:
Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.
Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.
Measured: During the 21 days after each vaccination
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)
A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).
Measured: Up to 180 days after the last vaccination

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.
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: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00958243
Sponsor's protocol ID: CSLCT-CAL-09-62
Status last verified: Apr 2018
First submitted: 12 Aug 2009
Last updated: 23 May 2018
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?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. 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 a Healthy Pediatric Population
ClinicalTrials.gov ID: NCT00958243
Acronym / sponsor ID: CSLCT-CAL-09-62
Conditions: Influenza
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 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 9 Aug 2011

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 evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Biological: PlaceboPlacebo
CSL425 (7.5 mcg)	Experimental	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)7.5 mcg of hemagglutinin antigen per dose
CSL425 (15 mcg)	Experimental	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)15 mcg of hemagglutinin antigen per dose

Who may qualify

Ages: 6 months to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
For children < 3 years of age at the time of first vaccination, born at or after 36 weeks gestation.

Key exclusion criteria (1 listed)

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, 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
CSL's 2009 H1N1 Influenza Vaccine (CSL425)0.5 mL intramuscular injection on Day 0 and Day 21	Biological	CSL425 (15 mcg)
CSL's 2009 H1N1 Influenza Vaccine (CSL425)0.25 mL intramuscular injection on Day 0 and Day 21	Biological	CSL425 (7.5 mcg)
PlaceboPlacebo	Biological	Placebo

Primary outcome

Seroconversion Rate 21 Days After First Study Vaccination
Time frame: 21 days after the first study 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.
Seroconversion Rate 21 Days After Second Study Vaccination
Time frame: 21 days after the second study 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 First Study Vaccination
Time frame: 21 days after the first study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
Time frame: 21 days after the second study vaccination

6 secondary outcomes

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Time frame: During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Time frame: During the 7 days after each study vaccination
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Time frame: During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Time frame: During the 7 days after each study vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Time frame: During the 21 days after each vaccination
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)
Time frame: Up to 180 days after the last vaccination

Results and safety

Results posted to the registry on 9 Aug 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
Placebo Cohort A	26	24
CSL425 (7.5 mcg) Cohort A	105	99
CSL425 (15 mcg) Cohort A	96	82
Placebo Cohort B	28	25
CSL425 (7.5 mcg) Cohort B	109	100
CSL425 (15 mcg) Cohort B	109	99

Primary outcome: Seroconversion Rate 21 Days After First Study Vaccination

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

Measure	Placebo Cohort A n = 25	CSL425 (7.5 mcg) Cohort A n = 102	CSL425 (15 mcg) Cohort A n = 89	Placebo Cohort B n = 27	CSL425 (7.5 mcg) Cohort B n = 104	CSL425 (15 mcg) Cohort B n = 102
Value	4.0 (0.1 to 20.4)	88.2 (80.4 to 93.8)	83.1 (73.7 to 90.2)	3.7 (0.1 to 19.0)	84.6 (76.2 to 90.9)	88.2 (80.4 to 93.8)

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

Primary outcome: Seroconversion Rate 21 Days After Second Study Vaccination

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

Measure	Placebo Cohort A n = 21	CSL425 (7.5 mcg) Cohort A n = 90	CSL425 (15 mcg) Cohort A n = 80	Placebo Cohort B n = 26	CSL425 (7.5 mcg) Cohort B n = 98	CSL425 (15 mcg) Cohort B n = 98
Value	28.6 (11.3 to 52.2)	98.9 (94.0 to 100.0)	100.0 (95.5 to 100.0)	15.4 (4.4 to 34.9)	98.0 (92.8 to 99.8)	99.0 (94.4 to 100.0)

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 (e.g., the use of a prohibited medication or a laboratory confirmed infection with 2009 H1N1 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 First Study Vaccination

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

Measure	Placebo Cohort A n = 25	CSL425 (7.5 mcg) Cohort A n = 102	CSL425 (15 mcg) Cohort A n = 89	Placebo Cohort B n = 27	CSL425 (7.5 mcg) Cohort B n = 104	CSL425 (15 mcg) Cohort B n = 102
Value	8.0 (1.0 to 26.0)	90.2 (82.7 to 95.2)	84.3 (75.0 to 91.1)	25.9 (11.1 to 46.3)	84.6 (76.2 to 90.9)	89.2 (81.5 to 94.5)

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

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

Measure	Placebo Cohort A n = 21	CSL425 (7.5 mcg) Cohort A n = 90	CSL425 (15 mcg) Cohort A n = 80	Placebo Cohort B n = 26	CSL425 (7.5 mcg) Cohort B n = 98	CSL425 (15 mcg) Cohort B n = 98
Value	28.6 (11.3 to 52.2)	98.9 (94.0 to 100.0)	100.0 (95.5 to 100.0)	34.6 (17.2 to 55.7)	98.0 (92.8 to 99.8)	100.0 (96.3 to 100.0)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 180 days after the last study vaccination for SAEs. 21 days after each study vaccination for unsolicited adverse events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Cohort A	0 of 26 (0%)	25 of 26 (96.2%)	Not reported
CSL425 (7.5 mcg) Cohort A	2 of 105 (1.9%)	58 of 105 (55.2%)	Not reported
CSL425 (15 mcg) Cohort A	3 of 96 (3.1%)	82 of 96 (85.4%)	Not reported
Placebo Cohort B	0 of 28 (0%)	22 of 28 (78.6%)	Not reported
CSL425 (7.5 mcg) Cohort B	0 of 107 (0%)	70 of 107 (65.4%)	Not reported
CSL425 (15 mcg) Cohort B	0 of 109 (0%)	49 of 109 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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.

Clinical Director Vaccines study director

Seqirus

13 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 CSL's 2009 H1N1 Influenza Vaccine (CSL425) in people with Influenza, run by Seqirus at 13 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 9 Aug 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?

Seroconversion Rate 21 Days After First Study Vaccination (time frame: 21 days after the first study 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 NCT00958243.

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 23 May 2018.