A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958243
• Other study ID #: CSLCT-CAL-09-62
• Status: Completed
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 473
• Est. completion date: April 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.5 mL intramuscular injection on Day 0 and Day 21
• CSL's 2009 H1N1 Influenza Vaccine (CSL425)
0.25 mL intramuscular injection on Day 0 and Day 21
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A	Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.	During the 7 days after each study vaccination
Secondary	Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A		During the 7 days after each study vaccination
Secondary	Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B	Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.	During the 7 days after each study vaccination
Secondary	Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B		During the 7 days after each study vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination	UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities.; Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.	During the 21 days after each vaccination
Secondary	Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)	A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).	Up to 180 days after the last vaccination