Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-Based Subunit Influenza Vaccines in Healthy Children and Adolescents - Full Text View

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00645411

Purpose

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Condition	Intervention	Phase
Influenza	Biological: Cell culture-derived Influenza Virus subunit vaccine Biological: egg derived vaccine	Phase II Phase III

MedlinePlus related topics: Flu

Drug Information available for: Influenza Vaccines Fluvirin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Combined Phase II/III, Observer-Blind, Randomized, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents

Further study details as provided by Novartis:

Primary Outcome Measures:

non-inferiority of the cell culture-derived influenza vaccine on the egg-derived influenza vaccine for all three strains after two doses administered four weeks apart to children 3 to 8 years of age (immunogenicity subset) [ Time Frame: 6-months observation period after last vaccination for each subject ] [ Designated as safety issue: No ]
safety/tolerability of 1 dose of cell culture-derived or egg-derived flu vax in children 9-17 years of age and of 2 doses of cell culture-derived or egg-derived flu vax, administered 4 weeks apart to children 3-8 years of age [ Time Frame: 6-months observation period after last vaccination for each subject ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity after 1 dose of cell culture-derived or egg-derived flu vaccine in children 9 to 17 years of age and after 2 doses of cell culture-derived or egg-derived flu vaccine, administered four weeks apart to children 3 to 8 years of age [ Time Frame: 6-months observation period after last vaccination for each subject ] [ Designated as safety issue: No ]

Enrollment:	3900
Study Start Date:	October 2007
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental MDCK cell culture derived vaccine	Biological: Cell culture-derived Influenza Virus subunit vaccine omitted
B: Active Comparator egg derived vaccine	Biological: egg derived vaccine omitted

Eligibility

Ages Eligible for Study:	3 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy children/adolescents aged 3 to 17 years, whose parents/legal guardians have consented participation
Able and willing to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

Exclusion Criteria:

any concurrent serious disease;
history of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, any other vaccine component;
known or suspected impairment/alteration of immune function;
history of Guillain-Barré syndrome;
receipt of another investigational agent within 90 days and/or currently participating in the long-term follow-up of another clinical trial and/or unwilling to refuse participation in another clinical study through the end of the study;
receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
laboratory-confirmed influenza disease within 6 months prior to Visit 1;
for subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season; for all subjects, receipt of an influenza vaccine within 6 months prior to Visit 1;
experienced a temperature of 38.0°C and above [100.4°F and above]) and/or any acute illness within 3 days prior to Visit 1;
pregnant or nursing mothers, or females of childbearing potential and sexually active that did not use acceptable birth control measures for at least 2 months prior to study entry and/or refusing to use acceptable birth control measures during the 3 weeks following vaccination and/or refusing to have a urine pregnancy test prior to enrollment;
research staff directly involved with the clinical study or family members or household members of research staff.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645411

Show 68 Study Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis Vaccines

More Information

Responsible Party:	Novartis ( Novartis Vaccines & Diagnostics S.r.l.; Via Fiorentina 1, I-53100 Siena, Italy )
Study ID Numbers:	V58P12, Eudract Number: 2007-001534-13
Study First Received:	March 21, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00645411
Health Authority:	Hungary: National Institute of Pharmacy; Romania: National Medicines Agency; Lithuania: State Medicines Control Agency; ITALY: Agenzia Italiana del Farmaco (AIFA); Finland: National Agency for Medicines (NAM); United States: Food and Drug Administration; Croatia: Ministry of Health and Social Care

Keywords provided by Novartis:

Influenza
Flu
Cell Culture-Derived
Egg-Derived
Healthy Children
Healthy Adolescents

Safety
Immunogenicity
Trivalent
Inactivated
Vaccination

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Influenza, Human
Healthy
Orthomyxoviridae Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009