Safety Study of CSL Limited's Influenza Virus Vaccine in the Paediatric Population Aged >= 6 Months to < 18 Years

Influenza Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825162
• Other study ID #: CSLCT-USF-06-29
• Status: Completed
• Phase: Phase 4
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1992
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.25mL)
• CSL Limited Influenza Virus Vaccine
Single or two-vaccination regimen (0.5mL)
• CSL Limited Influenza Virus Vaccine
Single vaccination regimen (0.5mL)

Locations

Country	Name	City	State
Australia	The Canberra Hospital	Garran	Australian Capital Territory
Australia	Royal Children's Hospital	Herston	Queensland
Australia	Murdoch Children's Research Institute	Melbourne	Victoria
Australia	Women's & Children's Hospital Adelaide	North Adelaide	South Australia
Australia	Sydney Children's Clinical Trials Centre	Randwick	New South Wales
Australia	Princess Margaret Hospital	Subiaco	Western Australia
Australia	Children's Hospital at Westmead	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.	7 days post-vaccination
Primary	Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.	7 days post-vaccination
Primary	Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.	7 days post-vaccination
Primary	Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.	7 days post-vaccination
Primary	Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.	7 days post-vaccination
Primary	Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years)	Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.	7 days post-vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	UAE stands for Unsolicited Adverse Event.	30 days after each study vaccination
Secondary	Frequency of Serious Adverse Events		180 days after the last study vaccination
Secondary	Frequency of New Onsets of Chronic Illness		180 days after the last study vaccination