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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00825162
Registration number
NCT00825162
Ethics application status
Date submitted
15/01/2009
Date registered
19/01/2009
Date last updated
23/05/2018
Titles & IDs
Public title
Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years
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Scientific title
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
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Secondary ID [1]
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CSLCT-USF-06-29
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CSL Limited Influenza Virus Vaccine
Other interventions - CSL Limited Influenza Virus Vaccine
Other interventions - CSL Limited Influenza Virus Vaccine
Experimental: Cohort A - Participants aged 6 months to less than 3 years
Experimental: Cohort B - Participants aged 3 years to less than 9 years
Experimental: Cohort C - Participants aged 9 years to less than 18 years
Other interventions: CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.25mL)
Other interventions: CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.5mL)
Other interventions: CSL Limited Influenza Virus Vaccine
Single vaccination regimen (0.5mL)
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
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Assessment method [1]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
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Timepoint [1]
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7 days post-vaccination
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Primary outcome [2]
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Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
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Assessment method [2]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
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Timepoint [2]
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7 days post-vaccination
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Primary outcome [3]
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Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
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Assessment method [3]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
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Timepoint [3]
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7 days post-vaccination
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Primary outcome [4]
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Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
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Assessment method [4]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
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Timepoint [4]
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7 days post-vaccination
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Primary outcome [5]
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Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
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Assessment method [5]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
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Timepoint [5]
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7 days post-vaccination
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Primary outcome [6]
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Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
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Assessment method [6]
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Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
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Timepoint [6]
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7 days post-vaccination
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Secondary outcome [1]
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Frequency and Intensity of Unsolicited Adverse Events (UAEs)
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Assessment method [1]
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UAE stands for Unsolicited Adverse Event.
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Timepoint [1]
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30 days after each study vaccination
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Secondary outcome [2]
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Frequency of Serious Adverse Events
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Assessment method [2]
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Timepoint [2]
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180 days after the last study vaccination
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Secondary outcome [3]
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Frequency of New Onsets of Chronic Illness
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Assessment method [3]
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Timepoint [3]
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180 days after the last study vaccination
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Eligibility
Key inclusion criteria
1. Healthy male or female participants aged = 6 months to < 18 years at the time of
vaccination;
2. Written informed consent to participate in the study and adherence to all protocol
requirements. Consent will be obtained from the participant, parent or guardian as
appropriate according to the applicable Independent Ethics Committee (IEC) and local
requirements. Participant assent will also be obtained if required by the applicable
IEC;
3. Good health, as determined by medical history, and a targeted physical examination;
4. For participants aged < 9 years, born after a normal gestation period (between 36 and
42 weeks);
5. Females of childbearing potential (defined as having experienced their first menstrual
cycle) must be abstinent or be using adequate contraceptive precautions e.g.
intrauterine contraceptive device, oral contraceptive, or equivalent hormonal
contraception (e.g., progestogen-only implant, vaginal contraceptive ring, cutaneous
hormonal patch or injectable contraceptives) for at least 2 months after vaccination.
Females aged = 9 years must also return a negative urine pregnancy test at enrolment.
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Minimum age
6
Months
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Maximum age
17
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,
chicken protein, neomycin, polymyxin, or any components of the Study Vaccine;
2. Clinical signs of significant active infection and/or an elevated temperature (=
38.0°C oral or = 37.5°C axillary) at study entry;
3. Vaccination against influenza virus in the previous 6 months with a seasonal IVV;
4. Vaccination with an experimental IVV (e.g. a candidate pandemic IVV or a novel IVV) in
the previous 6 months;
5. Females of child bearing potential, planning to become pregnant or planning to
discontinue contraceptive precautions within 2 months of vaccination;
6. Pregnant or lactating females;
7. Clinically significant medical or psychiatric conditions, as follows:
- For acute conditions (active or recent), the condition required hospitalisation
within the last month; or
- For chronic conditions: the Investigator feels that the chronic condition is
unstable, such as illness exacerbations within the previous month:
i. requiring hospitalisation; ii. with significant organ function deterioration;
iii. with major changes to treatment dosages; iv. requiring major new treatments;
or
- The Investigator feels the participant has a clinical condition that may be
adversely affected through study participation.
8. Confirmed or suspected immune deficiency (congenital or acquired, including cancer and
human immunodeficiency virus infection);
9. History of seizures, with the exception of a past history of a single seizure event at
any age more than two years previously;
10. Known history of Guillain-Barré Syndrome;
11. Current treatment with radiotherapy or cytotoxic drugs, or treatment within the 6
months prior to administration of the Study Vaccine;
12. Current (or within the 90 days prior to receiving the Study Vaccine) immunosuppressive
or immunomodulative therapy, including systemic corticosteroids, as follows:
• Chronic or long term corticosteroids: i. Age less than 9 years: = 0.5 mg/kg/day of
oral prednisolone or equivalent daily; ii. Age 9 years and above: = 15 mg/day of oral
prednisolone or equivalent daily;
• Sporadic corticosteroids: i. Age less than 9 years: = 1 mg/kg/day of oral
prednisolone or equivalent for 2 or more short courses of > 3 days in the 3 months
preceding vaccination; ii. Age 9 years and above: = 40 mg/day of oral prednisolone or
equivalent for two or more short courses of > 3 days in the 3 months preceding
vaccination; Note: Use of topical or inhalant corticosteroids prior to administration
of the Study Vaccine or throughout the Study is acceptable
13. Administration of immunoglobulins and/or any blood products within the 3 months
preceding the administration of the Study Vaccine or during the study;
14. Current treatment with warfarin or other anticoagulants;
15. Participation in a clinical trial or use of an investigational compound (i.e. a new
chemical or biological entity not registered for clinical use) within 90 days prior to
receiving the Study Vaccine or entry into such a study during the on study period;
16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
17. If, in the Investigator's opinion, the participant should not take part in the
clinical study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2010
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Sample size
Target
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Accrual to date
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Final
1992
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment hospital [2]
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Sydney Children's Clinical Trials Centre - Randwick
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Recruitment hospital [3]
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Children's Hospital at Westmead - Westmead
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Recruitment hospital [4]
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Royal Children's Hospital - Herston
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Recruitment hospital [5]
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Women's & Children's Hospital Adelaide - North Adelaide
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Recruitment hospital [6]
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Murdoch Children's Research Institute - Melbourne
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Recruitment hospital [7]
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Princess Margaret Hospital - Subiaco
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Recruitment postcode(s) [1]
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2606 - Garran
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Recruitment postcode(s) [2]
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2031 - Randwick
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment postcode(s) [4]
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4006 - Herston
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Recruitment postcode(s) [5]
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5006 - North Adelaide
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Recruitment postcode(s) [6]
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3053 - Melbourne
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Recruitment postcode(s) [7]
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6008 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Seqirus
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of
CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18
Years
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00825162
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Lambert, Dr
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Address
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Royal Children's Hospital, Brisbane, Herston, QLD, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00825162
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