A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Australia

Study Type

Interventional

Intervention

CSL425

About this trial

This is an interventional prevention trial for Influenza Caused by the Novel Influenza A (H1N1) Virus

Eligibility Criteria

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

Inclusion Criteria:

Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

Exclusion Criteria:

Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

Sites / Locations

Study Site
Study Site
Study Site
Study Site
Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CSL425 (15 mcg)

CSL425 (30 mcg)

Arm Description

15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Outcomes

Primary Outcome Measures

Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination

HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

HI Antibody Titre Seroconversion Rate After the Second Vaccination

HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination

GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

GMFI in the HI Antibody Titre After the Second Vaccination

GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination

Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination

Secondary Outcome Measures

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination

Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.

Duration of Solicited AEs After the First Vaccination

Solicited AEs included AEs that were specifically sought for.

Duration of Solicited AEs After the Second Vaccination

Solicited AEs included AEs that were specifically sought for.

Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)

An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).

Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination

Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.

Full Information

NCT ID

NCT00940108

First Posted

July 13, 2009

Last Updated

April 25, 2018

Sponsor

Seqirus

1. Study Identification

Unique Protocol Identification Number

NCT00940108

Brief Title

A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

Official Title

A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seqirus

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy children.

6. Conditions and Keywords

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

Influenza Caused by the Novel Influenza A (H1N1) Virus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

370 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CSL425 (15 mcg)

Arm Type

Experimental

Arm Description

15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Arm Title

CSL425 (30 mcg)

Arm Type

Experimental

Arm Description

30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21

Intervention Type

Biological

Intervention Name(s)

CSL425

Intervention Description

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Intervention Type

Biological

Intervention Name(s)

CSL425

Intervention Description

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Primary Outcome Measure Information:

Title

Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination

Description

HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

Time Frame

Before and 21 days after the first vaccination

Title

HI Antibody Titre Seroconversion Rate After the Second Vaccination

Description

HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.

Time Frame

Before and 21 days after the second vaccination

Title

Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination

Description

GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

Time Frame

Before and 21 days after the first vaccination

Title

GMFI in the HI Antibody Titre After the Second Vaccination

Description

GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.

Time Frame

Before and 21 days after the second vaccination

Title

Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination

Time Frame

21 days after the first vaccination

Title

Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination

Time Frame

21 days after the second vaccination

Secondary Outcome Measure Information:

Title

Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination

Description

Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.

Time Frame

During the 7 days after each vaccination

Title

Duration of Solicited AEs After the First Vaccination

Description

Solicited AEs included AEs that were specifically sought for.

Time Frame

During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.

Title

Duration of Solicited AEs After the Second Vaccination

Description

Solicited AEs included AEs that were specifically sought for.

Time Frame

During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.

Title

Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)

Description

An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).

Time Frame

Up to 180 days after the last vaccination

Title

Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination

Description

Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.

Time Frame

During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

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: Male or female aged >= 6 months to < 9 years at the time of the first study vaccination. For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation. Exclusion Criteria: Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, neomycin, polymyxin, or any components of the Study Vaccine.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Director Vaccines

Organizational Affiliation

Seqirus

Official's Role

Study Director

Facility Information:

Facility Name

Study Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Study Site

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4006

Country

Australia

Facility Name

Study Site

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Study Site

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3010

Country

Australia

Facility Name

Study Site

City

Subiaco

State/Province

Western Australia

ZIP/Postal Code

6027

Country

Australia

12. IPD Sharing Statement

Citations:

PubMed Identifier

20026597

Citation

Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.

Results Reference

result

Influenza Caused by the Novel Influenza A (H1N1) Virus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial