Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00971542

First received: September 2, 2009

Last updated: October 10, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 2, 2009
Last Updated Date	October 10, 2011
Start Date ^ICMJE	September 2009
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2011)	To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents [ Time Frame: 43 days after first vaccination ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: September 2, 2009)	To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents [ Time Frame: Approximately 19 months, including 6 months follow-up period ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00971542 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2011)	To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria. [ Time Frame: 3 weeks after booster vaccination ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 2, 2009)	To evaluate: immunogenicity of 3rd dose of H1N1 sw monovalent vaccine admin 12mo after the 1st vaccination; safety & tolerability of the vaccine for 3wk after 1st & 2nd vaccination; safety & tolerability of the vaccine upto 6mo after the last vaccination [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine (Egg-Derived) in Healthy Subjects From 6 Months to 17 Years of Age
Official Title ^ICMJE	A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Egg-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age
Brief Summary	The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Pandemic Influenza
Intervention ^ICMJE	Biological: Monovalent A/H1N1 influenza vaccine This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen & adjuvant, or high dose of antigen & adjuvant, or high dose of antigen, according to the study groups.
Study Arm (s)	Experimental: low dose of antigen + low dose of adjuvant Intervention: Biological: Monovalent A/H1N1 influenza vaccine Experimental: high dose of antigen + high dose of adjuvant Intervention: Biological: Monovalent A/H1N1 influenza vaccine Experimental: high dose of antigen Intervention: Biological: Monovalent A/H1N1 influenza vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	778
Completion Date	July 2011
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males and females 6 months of age to 17 years of age on the day of enrollment; Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable; Individuals in good health; Subjects, subject's parents or legal guardians that are able to comply with all study procedures; Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response. Exclusion Criteria: Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures; Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study; Individuals with any serious chronic or progressive disease according to judgment of the investigator; History of any anaphylaxis, serious vaccine reactions to any excipients and to eggs (including ovalbumin) and chicken protein; Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1. Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study; Individuals who receive any other vaccine 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within four weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until one week prior to and after one week study vaccinations; Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks; Individuals with axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination; Known or suspected alteration of immune function; History of progressive or severe neurologic disorder; Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule; If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry; Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination; Members of research staff or their relatives.
Gender	Both
Ages	6 Months to 17 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Belgium, Chile, Dominican Republic, Germany, Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00971542
Other Study ID Numbers ^ICMJE	V111_03, 2009-013672-45
Has Data Monitoring Committee	Not Provided
Responsible Party	Novartis ( Novartis Vaccines )
Study Sponsor ^ICMJE	Novartis Vaccines
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Novartis
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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