Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00408395

First received: December 5, 2006

Last updated: November 30, 2016

Last verified: December 2011

History of Changes

Purpose

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

Condition	Intervention	Phase
Influenza	Biological: Influenza vaccine	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Flu Flu Shot

Drug Information available for: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Novartis ( Novartis Vaccines ):

Primary Outcome Measures:

To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test

Secondary Outcome Measures:

To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart


Enrollment:	281
Study Start Date:	November 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1: Trivalent Seasonal Influenza Vaccine	Biological: Influenza vaccine Seasonal Influenza Vaccine
Experimental: 2: Adjuvanted Trivalent Seasonal Influenza Vaccine	Biological: Influenza vaccine Seasonal Influenza Vaccine

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

Eligibility


Ages Eligible for Study:	6 Months to 35 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408395

Locations


Finland
University of Tampere Medical School
Tampere, Finland, 33014

Sponsors and Collaborators

Novartis Vaccines

Investigators


Study Chair:	Novartis Vaccines (formerly Chiron Vaccines)	Novartis

More Information

Publications:

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.


Responsible Party:	Novartis Vaccines
ClinicalTrials.gov Identifier:	NCT00408395 History of Changes
Other Study ID Numbers:	V70P2 2006-003181-34
Study First Received:	December 5, 2006
Last Updated:	November 30, 2016

Keywords provided by Novartis ( Novartis Vaccines ):


influenza children vaccine influenza disease

Additional relevant MeSH terms:


Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections	Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 18, 2017

To Top