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A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

Primary Purpose

Influenza

Status

Completed

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Influenza Virus Vaccine

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Months - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months
Parent(s) or Guardian(s) to provide written informed consent to participate in the study;
Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and
Be born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine;
Previous influenza vaccination;
Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator;
Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV);
Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows:
•Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable).
Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period;
Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period;
Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine;
Have a known history of Guillain-Barré Syndrome;
Have a major congenital defect or serious illness and
Have a history of neurologic disorders or seizures

Sites / Locations

Murdoch Childrens Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Group A

Group B

Arm Description

Equal to or greater 6 months to less than 3 years old

Equal to or greater 3 years to less than 9 years old

Outcomes

Primary Outcome Measures

Safety of CSL Influenza Virus Vaccine in a Paediatric population through the assessment of the frequency of Local and general solicited symptoms, Unsolicited Adverse Events (UAE),Serious Adverse Events (SAEs)

Secondary Outcome Measures

Evaluate immunogenicity response to CSL Influenza Virus Vaccine in Paediatric population according to the criteria of the CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines

Full Information

NCT ID

NCT00700193

First Posted

June 17, 2008

Last Updated

July 17, 2016

Sponsor

Seqirus

1. Study Identification

Unique Protocol Identification Number

NCT00700193

Brief Title

A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

Official Title

An Open-Label, Multi-Centre Study to Evaluate the Safety, Tolerability and Immunogenicity of CSL's Influenza Vaccine in a Paediatric Population (= or >6 Months to < 9 Years of Age).

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Seqirus

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month booster vaccination, in a paediatric population equal to or greater than 6 months to less than 9 years old.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

298 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Other

Arm Description

Equal to or greater 6 months to less than 3 years old

Arm Title

Group B

Arm Type

Other

Arm Description

Equal to or greater 3 years to less than 9 years old

Intervention Type

Biological

Intervention Name(s)

Influenza Virus Vaccine

Intervention Description

2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose

Intervention Type

Biological

Intervention Name(s)

Influenza Virus Vaccine

Intervention Description

2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose

Primary Outcome Measure Information:

Title

Time Frame

Local & general solicited symptoms for 7 days post each vaccination, UAEs for 30 days post each vaccination, SAEs for 6 months after the last primary vaccination and 6 months after the booster vaccination

Secondary Outcome Measure Information:

Title

Time Frame

30 days after each vaccine dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be healthy male or female children, aged = or > 6 months to < 9 years at the time of first study vaccination; Note: = or > 6 refers to 6 calendar months Parent(s) or Guardian(s) to provide written informed consent to participate in the study; Be able to provide a pre-vaccination sample of up to 5mL of venous blood without undue distress/discomfort and Be born after a normal gestation period (between 36 and 42 weeks). Exclusion Criteria: Known allergy to eggs, chicken feathers, neomycin, polymyxin, or any components of the vaccine; Previous influenza vaccination; Clinical signs of active infection and/or an axillary temperature of = or >37.5 degrees Celsius or oral temperature of = or >38 degrees Celsius at study entry. Study entry may be deferred for such individuals, at the discretion of the Principal Investigator; Confirmed or suspected immunosuppressive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder (including HIV); Current (or within the 90 days prior to receiving the Study Vaccine) treatment with immunosuppressive or immunomodulative medication, including systemic corticosteroids, as follows: •Chronic or long term corticosteroids: >0.5mg/kg/day of oral prednisolone or equivalent (Note: Use of topical or inhalant corticosteroids prior to administration of the Study Vaccine or throughout the Study is acceptable). Administration of immunoglobulins and/or any blood products since birth or planned administration of such blood products during the study period; Participation in a clinical study or use of an investigational compound (ie a new chemical or biological entity not registered for clinical use), within the 90 days prior to receiving the Study Vaccine or be planning to enter such a study during the study period; Current treatment with cytotoxic drugs or treatment within the 6 months prior to administration of the Study Vaccine; Have a known history of Guillain-Barré Syndrome; Have a major congenital defect or serious illness and Have a history of neurologic disorders or seizures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Terry M Nolan, Prof

Organizational Affiliation

Murdoch Childrens Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Murdoch Childrens Research Institute

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

12. IPD Sharing Statement

Learn more about this trial

A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population

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