A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population
1 other identifier
interventional
473
1 country
13
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2009
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 12, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
August 9, 2011
CompletedMay 23, 2018
April 1, 2018
3 months
August 12, 2009
July 13, 2011
April 25, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Seroconversion Rate 21 Days After First Study Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the first study vaccination
Seroconversion Rate 21 Days After Second Study Vaccination
Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.
21 days after the second study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
21 days after the first study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
21 days after the second study vaccination
Secondary Outcomes (6)
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
During the 7 days after each study vaccination
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
During the 7 days after each study vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
During the 21 days after each vaccination
- +1 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
CSL425 (7.5 mcg)
EXPERIMENTAL7.5 mcg of hemagglutinin antigen per dose
CSL425 (15 mcg)
EXPERIMENTAL15 mcg of hemagglutinin antigen per dose
Interventions
0.5 mL intramuscular injection on Day 0 and Day 21
Eligibility Criteria
You may qualify if:
- 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 gestation.
You may not qualify if:
- Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (13)
Unknown Facility
Chandler, Arizona, 85224, United States
Unknown Facility
Melbourne, Florida, 32935, United States
Unknown Facility
Bardstown, Kentucky, 40004, United States
Unknown Facility
Metairie, Louisiana, 70006, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Austintown, Ohio, 44515, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Latrobe, Pennsylvania, 15650, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15227, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Fort Worth, Texas, 76135, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Murray, Utah, 84107, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Disclosure Manager
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Director Vaccines
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2009
First Posted
August 13, 2009
Study Start
August 1, 2009
Primary Completion
November 1, 2009
Study Completion
April 1, 2010
Last Updated
May 23, 2018
Results First Posted
August 9, 2011
Record last verified: 2018-04