A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
This study has been completed.
Sponsor:
CSL Limited
Information provided by:
CSL Limited
ClinicalTrials.gov Identifier:
NCT00940108
First received: July 13, 2009
Last updated: May 22, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Caused by the Novel Influenza A (H1N1) Virus |
Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by CSL Limited:
Primary Outcome Measures:
- Immunogenicity [ Time Frame: 21 days after each vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Frequency,duration and intensity of solicited adverse events [ Time Frame: During the 7 days after each vaccination ] [ Designated as safety issue: Yes ]
- Frequency, duration and intensity of unsolicited adverse events [ Time Frame: During the 21 days after each vaccination ] [ Designated as safety issue: Yes ]
- Incidence of Serious Adverse Events, Adverse Events of Special Interest (AESI's) and new onset of Chronic Illnesses [ Time Frame: From the time of providing informed consent up to 180 days after the last vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 369 |
| Study Start Date: | July 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 15 mcg HA dose group
15 mcg of HA antigen per dose
|
Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
|
Experimental: 30 mcg HA dose group
30 mcg of HA antigen per dose
|
Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
|
Eligibility| Ages Eligible for Study: | 6 Months to 8 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940108
Locations
| Australia, New South Wales | |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, Queensland | |
| Brisbane, Queensland, Australia, 4006 | |
| Australia, South Australia | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Carlton, Victoria, Australia, 3010 | |
| Australia, Western Australia | |
| Subiaco, Western Australia, Australia, 6027 | |
Sponsors and Collaborators
CSL Limited
More Information
Publications:
| Responsible Party: | Dr Russell Basser, CSL Limited |
| ClinicalTrials.gov Identifier: | NCT00940108 History of Changes |
| Other Study ID Numbers: | CSLCT-CAL-09-60 |
| Study First Received: | July 13, 2009 |
| Last Updated: | May 22, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013