Influenza Caused by the Novel Influenza A (H1N1) VirusPhase 2NCT00940108

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

A Phase 2 study testing CSL425 in people with Influenza Caused by the Novel Influenza A (H1N1) Virus, run by Seqirus at 5 sites in Australia.

Completed

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

Official record

Search all trials

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 children. Read more about this study

Who is it for?: Ages 6 months to 8 yearsHealthy volunteers can take part
Conditions the study is for: Influenza Caused by the Novel Influenza A (H1N1) Virus
What is being tested?: CSL425
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 370 participants
Where: 5 sitesAustralia
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 8 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 of gestation.

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Australia5 sites

Study Site
Brisbane, Queensland, 4006
Study Site
Carlton, Victoria, 3010
Study Site
North Adelaide, South Australia, 5006
Study Site
Subiaco, Western Australia, 6027
Study Site
Westmead, New South Wales, 2145

Other trials in Australia

About this study

Official title: A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

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 children.

Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
Being tested: CSL425
Medical subject headings: Virus Diseases

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-free

Study groups in NCT00940108
Study group	Role	What they receive
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

What is being measured

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

Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Measured: Before and 21 days after the first vaccination
HI Antibody Titre Seroconversion Rate After the Second Vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Measured: Before and 21 days after the second vaccination
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Measured: Before and 21 days after the first vaccination
GMFI in the HI Antibody Titre After the Second Vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Measured: Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
Measured: 21 days after the first vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
Measured: 21 days after the second vaccination

Secondary outcomes (5)

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.
Measured: During the 7 days after each vaccination
Duration of Solicited AEs After the First Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Duration of Solicited AEs After the Second Vaccination
Solicited AEs included AEs that were specifically sought for.
Measured: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. 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 After the First or Second Vaccination
Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.
Measured: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

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 posted15 Jul 2009 (estimated)
Study startAug 2009
Primary completionOct 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 Influenza Caused by the Novel Influenza A (H1N1) VirusStudies 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: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00940108
Sponsor's protocol ID: CSLCT-CAL-09-60
Status last verified: Apr 2018
First submitted: 13 Jul 2009
Last updated: 28 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.
PubMed 20026597

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
ClinicalTrials.gov ID: NCT00940108
Acronym / sponsor ID: CSLCT-CAL-09-60
Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: SeqirusIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Oct 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 15 Jul 2009 (estimated)
Results: Posted 20 Nov 2013

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 children.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 6 months to 8 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 of gestation.

Key exclusion criteria (1 listed)

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, 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 (15 mcg)
CSL425CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free	Biological	CSL425 (30 mcg)

Primary outcome

Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
Time frame: Before and 21 days after the first vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
HI Antibody Titre Seroconversion Rate After the Second Vaccination
Time frame: Before and 21 days after the second vaccination
HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
Time frame: Before and 21 days after the first vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
GMFI in the HI Antibody Titre After the Second Vaccination
Time frame: Before and 21 days after the second vaccination
GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
Time frame: 21 days after the first vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
Time frame: 21 days after the second vaccination

5 secondary outcomes

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
Time frame: During the 7 days after each vaccination
Duration of Solicited AEs After the First Vaccination
Time frame: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Duration of Solicited AEs After the Second Vaccination
Time frame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
Time frame: Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
Time frame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

Results and safety

Results posted to the registry on 20 Nov 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
CSL425 (15 mcg) Cohort A	82	77
CSL425 (30 mcg) Cohort A	80	71
CSL425 (15 mcg) Cohort B	103	100
CSL425 (30 mcg) Cohort B	104	99

Primary outcome: Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination

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

Measure	CSL425 (15 mcg) Cohort A n = 76	CSL425 (30 mcg) Cohort A n = 73	CSL425 (15 mcg) Cohort B n = 98	CSL425 (30 mcg) Cohort B n = 99
Value	88.2 (78.7 to 94.4)	97.3 (90.5 to 99.7)	85.7 (77.2 to 92.0)	91.9 (84.7 to 96.4)

Population analysed: The Evaluable Population (for the first vaccination) comprised all randomised 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: HI Antibody Titre Seroconversion Rate After the Second Vaccination

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

Measure	CSL425 (15 mcg) Cohort A n = 64	CSL425 (30 mcg) Cohort A n = 69	CSL425 (15 mcg) Cohort B n = 95	CSL425 (30 mcg) Cohort B n = 96
Value	96.9 (89.2 to 99.6)	98.6 (92.2 to 100.0)	97.9 (92.6 to 99.7)	96.9 (91.1 to 99.4)

Population analysed: The Evaluable Population (for the second vaccination) comprised all randomised 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).

Primary outcome: Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination

Time frame: Before and 21 days after the first vaccination. Geometric mean (95% Confidence Interval). Unit: geometric mean fold increase

Measure	CSL425 (15 mcg) Cohort A n = 76	CSL425 (30 mcg) Cohort A n = 73	CSL425 (15 mcg) Cohort B n = 98	CSL425 (30 mcg) Cohort B n = 99
Value	13.95 (11.39 to 17.09)	22.17 (17.87 to 27.49)	13.25 (10.84 to 16.19)	15.93 (12.87 to 19.71)

Primary outcome: GMFI in the HI Antibody Titre After the Second Vaccination

Time frame: Before and 21 days after the second vaccination. Geometric mean (95% Confidence Interval). Unit: geometric mean fold increase

Measure	CSL425 (15 mcg) Cohort A n = 64	CSL425 (30 mcg) Cohort A n = 69	CSL425 (15 mcg) Cohort B n = 95	CSL425 (30 mcg) Cohort B n = 96
Value	57.64 (42.87 to 77.50)	72.93 (56.10 to 94.80)	37.48 (28.33 to 49.58)	37.06 (28.77 to 47.75)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CSL425 (15 mcg) Cohort A	4 of 82 (4.9%)	81 of 82 (98.8%)	Not reported
CSL425 (30 mcg) Cohort A	1 of 80 (1.3%)	78 of 80 (97.5%)	Not reported
CSL425 (15 mcg) Cohort B	1 of 103 (1%)	91 of 103 (88.3%)	Not reported
CSL425 (30 mcg) Cohort B	1 of 104 (1%)	96 of 104 (92.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20026597Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.

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

5 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 Caused by the Novel Influenza A (H1N1) Virus, run by Seqirus at 5 sites in Australia.

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 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Australia. 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 20 Nov 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?

Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination (time frame: Before and 21 days after the first vaccination). The study lists 6 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 NCT00940108, 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 28 Jun 2018.