Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

NCT ID: NCT00408395

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 281 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2007-08-31

Brief Summary

This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

Detailed Description

A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1: Trivalent Seasonal Influenza Vaccine

Group Type: EXPERIMENTAL

Influenza vaccine

Intervention Type: BIOLOGICAL

Seasonal Influenza Vaccine

2: Adjuvanted Trivalent Seasonal Influenza Vaccine

Group Type: EXPERIMENTAL

Influenza vaccine

Intervention Type: BIOLOGICAL

Seasonal Influenza Vaccine

Interventions

Influenza vaccine

Seasonal Influenza Vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 6 months to < 36 months of age

Exclusion Criteria

• Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
• Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
• Known or suspected impairment/alteration of immune function
• History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines (formerly Chiron Vaccines)

Role: STUDY_CHAIR

Novartis

Locations

University of Tampere Medical School

Tampere, , Finland

Countries

Finland

References

Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394.

Reference Type: RESULT

PMID: 19561422 (View on PubMed)

Other Identifiers

2006-003181-34

Identifier Type: -

Identifier Source: secondary_id

V70P2

Identifier Type: -

Identifier Source: org_study_id