Clinical trial NCT00958243: A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 473
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 gestation.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Seroconversion Rate 21 Days After First Study Vaccination
timeFrame: 21 days after the first study vaccination
measure: Seroconversion Rate 21 Days After Second Study Vaccination
timeFrame: 21 days after the second study vaccination
measure: Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
timeFrame: 21 days after the first study vaccination
measure: Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
timeFrame: 21 days after the second study vaccination
Secondary outcomes:
measure: Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
timeFrame: During the 7 days after each study vaccination
measure: Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
timeFrame: During the 7 days after each study vaccination
measure: Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
timeFrame: During the 7 days after each study vaccination
measure: Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
timeFrame: During the 7 days after each study vaccination
measure: Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
timeFrame: During the 21 days after each vaccination
measure: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)
timeFrame: Up to 180 days after the last vaccination
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Melbourne
country: United States
state: Florida
city: Bardstown
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Omaha
country: United States
state: Nebraska
city: Austintown
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Latrobe
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Murray
country: United States
state: Utah
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References: