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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
CSLCT-USF-06-29
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CSL Limited Influenza Virus Vaccine
Treatment: Other - CSL Limited Influenza Virus Vaccine
Treatment: Other - 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


Treatment: Other: CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.25mL)

Treatment: Other: CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.5mL)

Treatment: Other: CSL Limited Influenza Virus Vaccine
Single vaccination regimen (0.5mL)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Timepoint [1] 0 0
7 days post-vaccination
Primary outcome [2] 0 0
Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)
Timepoint [2] 0 0
7 days post-vaccination
Primary outcome [3] 0 0
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Timepoint [3] 0 0
7 days post-vaccination
Primary outcome [4] 0 0
Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)
Timepoint [4] 0 0
7 days post-vaccination
Primary outcome [5] 0 0
Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Timepoint [5] 0 0
7 days post-vaccination
Primary outcome [6] 0 0
Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)
Timepoint [6] 0 0
7 days post-vaccination
Secondary outcome [1] 0 0
Frequency and Intensity of Unsolicited Adverse Events (UAEs)
Timepoint [1] 0 0
30 days after each study vaccination
Secondary outcome [2] 0 0
Frequency of Serious Adverse Events
Timepoint [2] 0 0
180 days after the last study vaccination
Secondary outcome [3] 0 0
Frequency of New Onsets of Chronic Illness
Timepoint [3] 0 0
180 days after the last study vaccination

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.
Minimum age
6 Months
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
1992
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Sydney Children's Clinical Trials Centre - Randwick
Recruitment hospital [3] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 0 0
Royal Children's Hospital - Herston
Recruitment hospital [5] 0 0
Women's & Children's Hospital Adelaide - North Adelaide
Recruitment hospital [6] 0 0
Murdoch Children's Research Institute - Melbourne
Recruitment hospital [7] 0 0
Princess Margaret Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4006 - Herston
Recruitment postcode(s) [5] 0 0
5006 - North Adelaide
Recruitment postcode(s) [6] 0 0
3053 - Melbourne
Recruitment postcode(s) [7] 0 0
6008 - Subiaco

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seqirus
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT00825162
Trial related presentations / publications
Lambert SB, Chuk LM, Nissen MD, Nolan TM, McVernon J, Booy R, Heron L, Richmond PC, Walls T, Marshall HS, Reynolds GJ, Hartel GF, Hu W, Lai MH. Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents. Influenza Other Respir Viruses. 2013 Sep;7(5):676-85. doi: 10.1111/irv.12107. Epub 2013 Apr 2.
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Lambert, Dr
Address 0 0
Royal Children's Hospital, Brisbane, Herston, QLD, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00825162