A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

Influenza Clinical Trial

Official title:

A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959049
• Other study ID #: CSLCT-USF-07-36
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2009
• Last updated: July 14, 2015
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: July 2015
• Source: CSL Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1474
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 17 Years

Eligibility

Inclusion Criteria:

• Healthy male or non-pregnant female participants aged = 6 calendar months to < 18 years at the time of the first study vaccination.

• For participants aged = 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).

• Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged = 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CSL's Influenza Virus Vaccine (Afluria)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines
• Influenza Virus Vaccine (Fluzone)
0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center- Division of Infectious Disease	Cincinnati	Ohio
United States	UPMC / Community Medicine Inc	Greenville	Pennsylvania
United States	Pediatric Associates of Latrobe	Latrobe	Pennsylvania
United States	Pediatric Alliance Greentree Division	Pittsburgh	Pennsylvania
United States	South Hills Pediatrics	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
CSL Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer 30 Days After the Last Study Vaccination		30 days after the last study vaccination	No
Primary	Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination	Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.	30 days after the last study vaccination	No
Secondary	Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)		7 days after each vaccination	Yes
Secondary	Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B		7 days after each vaccination	Yes
Secondary	Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C		7 days after vaccination	Yes
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	UAE stands for Unsolicited Adverse Events	30 days after each vaccination	Yes
Secondary	New Onset of Chronic Illnesses (NOCIs)	New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).	6 months after last study vaccination	Yes
Secondary	Serious Adverse Events (SAEs)		6 months after last study vaccination	Yes
Secondary	Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)		7 days after each vaccination	Yes
Secondary	Duration of Local and Systemic Solicited Symptoms, Cohort B		7 days after each vaccination	Yes
Secondary	Duration of Local and Systemic Solicited Symptoms, Cohort C		7 days after vaccination	Yes