Influenza, HumanPhase 4NCT02212106
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
A Phase 4 study testing bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) and Comparator Quadrivalent Influenza Virus Vaccine in people with Influenza, Human, run by Seqirus at 11 sites in United States.
Trial summary
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) and Comparator Quadrivalent Influenza Virus Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 11 sitesUnited States
- Study dates
- Sep 2014to Dec 2014
- Phase
- Phase 4
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Who cannot join
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
Show all 9Show fewer
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Site 283
Austin, Texas, 78705
Site 285
Binghamton, New York, 13901
Site 289
Boise, Idaho, 83642
Site 284
Charleston, South Carolina, 29403
Site 290
Durham, North Carolina, 27704
Site 282
Fort Worth, Texas, 76135
Site 286
Los Angeles, California, 90036
Site 281
Raleigh, North Carolina, 27609
Site 288
San Angelo, Texas, 76904
Site 287
St Louis, Missouri, 63141
Site 280
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
- Conditions
- Influenza, Human
- Being tested
- bioCSL Trivalent Influenza Virus Vaccine (CSL TIV), Comparator Quadrivalent Influenza Virus Vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)Biological
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Comparator Quadrivalent Influenza Virus VaccineBiological
Also called Fluzone Quadrivalent
Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) | Experimental | The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). Receives: Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) |
| Comparator Quadrivalent Influenza Virus Vaccine | Active comparator | The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season. Receives: Biological: Comparator Quadrivalent Influenza Virus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
Measured: 7 days after each administration of vaccine.
Secondary outcomes (6)
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
Measured: 7 days after each administration of vaccine.
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).
Measured: 7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
Measured: 7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
Measured: 7 days after each administration of vaccine.
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.
Measured: 7 days after each administration of vaccine.
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
The number of subjects experiencing at least one SAE.
Measured: 7 days after each administration of vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
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 Influenza, HumanStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seqirus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- bioCSL Pty Ltd Clinical Program Director, Study director, Seqirus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212106
- Sponsor's protocol ID
- CSLCT-USF-10-69
- Other IDs
- 2015-000175-27, 2015
- Status last verified
- Sep 2015
- First submitted
- 6 Aug 2014
- Last updated
- 16 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.
- ClinicalTrials.gov ID
- NCT02212106
- Acronym / sponsor ID
- CSLCT-USF-10-69
- Conditions
- Influenza, Human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- SeqirusIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Posted 16 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) | Experimental | Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). |
| Comparator Quadrivalent Influenza Virus Vaccine | Active comparator | Biological: Comparator Quadrivalent Influenza Virus VaccineThe comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Key exclusion criteria (9 listed)
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
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 |
|---|---|---|
| bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection. | Biological | bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) |
| Comparator Quadrivalent Influenza Virus VaccineAlso: Fluzone QuadrivalentSubjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection. | Biological | Comparator Quadrivalent Influenza Virus Vaccine |
Primary outcome
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
Time frame: 7 days after each administration of vaccine.
The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
6 secondary outcomes
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
Time frame: 7 days after each administration of vaccine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
- 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.
bioCSL Pty Ltd Clinical Program Director 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 4 study testing bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) and Comparator Quadrivalent Influenza Virus Vaccine in people with Influenza, Human, 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 3 inclusion and 9 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 16 Oct 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Oct 2015). 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?
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine. (time frame: 7 days after each administration of vaccine.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2015.