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

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

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.

Study Overview

• Status: Completed
• Conditions: Pandemic Influenza
• Intervention / Treatment: Biological: Monovalent A/H1N1 influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 778
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Gent, Antwerpen, Belgium
• Chile
  • Santiago, Chile
    • Santigo de chile
• Dominican Republic
  • Gazcue Santo Domingo, Dominican Republic
    • Gazcue Santo Domingo
• Germany
  • Mainz, Germany
    • Wurzburg, Fulda, Neumunster, Balve, Stuttgart-Feuerbach, Leipzig, Rostock, Mainz, Detmold, Alsfeld
• Netherlands
  • Rotterdam, Netherlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and females 6 months of age to 17 years of age on the day of enrollment;
2. Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable;
3. Individuals in good health;
4. Subjects, subject's parents or legal guardians that are able to comply with all study procedures;
5. 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:

1. Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures;
2. 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;
3. Individuals with any serious chronic or progressive disease according to judgment of the investigator;
4. History of any anaphylaxis, serious vaccine reactions to any excipients and to eggs (including ovalbumin) and chicken protein;
5. Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1.
6. 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;
7. 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;
8. Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
9. Individuals with axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination;
10. Known or suspected alteration of immune function;
11. History of progressive or severe neurologic disorder;
12. Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
13. If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry;
14. 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;
15. Members of research staff or their relatives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low dose of antigen + low dose of adjuvant	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.
Experimental: high dose of antigen + high dose of adjuvant	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.
Experimental: high dose of antigen	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents	43 days after first vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	3 weeks after booster vaccination

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• Knuf M, Leroux-Roels G, Rumke HC, Abarca K, Rivera L, Lattanzi M, Pedotti P, Arora A, Kieninger-Baum D, Della Cioppa G. Safety and immunogenicity of an MF59-adjuvanted A/H1N1 pandemic influenza vaccine in children from three to seventeen years of age. Vaccine. 2015 Jan 1;33(1):174-81. doi: 10.1016/j.vaccine.2014.10.085. Epub 2014 Nov 11.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 2, 2009
• First Submitted That Met QC Criteria: September 2, 2009
• First Posted (Estimate): September 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 12, 2011
• Last Update Submitted That Met QC Criteria: October 10, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Vaccine; Pandemic influenza
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V111_03; 2009-013672-45 (EudraCT Number)