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

• ClinicalTrials.gov Identifier: NCT00825162
• Recruitment Status: Completed
• First Posted: January 19, 2009
• Results First Posted: July 29, 2011
• Last Update Posted: May 23, 2018
• Sponsor: Seqirus
• Information provided by (Responsible Party): Seqirus

Study Description

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

Condition or disease	Intervention/treatment	Phase
Influenza	Biological: CSL Limited Influenza Virus Vaccine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1992 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: March 2009
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort A; Participants aged 6 months to less than 3 years	Biological: CSL Limited Influenza Virus Vaccine; Single or two-vaccination regimen (0.25mL)
Experimental: Cohort B; Participants aged 3 years to less than 9 years	Biological: CSL Limited Influenza Virus Vaccine; Single or two-vaccination regimen (0.5mL)
Experimental: Cohort C; Participants aged 9 years to less than 18 years	Biological: CSL Limited Influenza Virus Vaccine; Single vaccination regimen (0.5mL)

Outcome Measures

Primary Outcome Measures :

1. Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
2. Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability.
3. Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
4. Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
5. Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
6. Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) [ Time Frame: 7 days post-vaccination ]
   Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.

Secondary Outcome Measures :

1. Frequency and Intensity of Unsolicited Adverse Events (UAEs) [ Time Frame: 30 days after each study vaccination ]
   UAE stands for Unsolicited Adverse Event.
2. Frequency of Serious Adverse Events [ Time Frame: 180 days after the last study vaccination ]
3. Frequency of New Onsets of Chronic Illness [ Time Frame: 180 days after the last study vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Australia, Australian Capital Territory

The Canberra Hospital

Garran, Australian Capital Territory, Australia, 2606

Australia, New South Wales

Sydney Children's Clinical Trials Centre

Randwick, New South Wales, Australia, 2031

Children's Hospital at Westmead

Westmead, New South Wales, Australia, 2145

Australia, Queensland

Royal Children's Hospital

Herston, Queensland, Australia, 4006

Australia, South Australia

Women's & Children's Hospital Adelaide

North Adelaide, South Australia, Australia, 5006

Australia, Victoria

Murdoch Children's Research Institute

Melbourne, Victoria, Australia, 3053

Australia, Western Australia

Princess Margaret Hospital

Subiaco, Western Australia, Australia, 6008

Sponsors and Collaborators

Seqirus

Investigators

• Principal Investigator: Stephen Lambert, Dr; Royal Children's Hospital, Brisbane, Herston, QLD, Australia

More Information

Publications of Results:

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.

• Responsible Party: Seqirus
• ClinicalTrials.gov Identifier: NCT00825162
• Other Study ID Numbers: CSLCT-USF-06-29
• First Posted: January 19, 2009
• Results First Posted: July 29, 2011
• Last Update Posted: May 23, 2018
• Last Verified: April 2018

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs