Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects 18 or More Years of Age

NCT00970177 | Completed Phase 3

• 2 other identifiers: V110_032009-013639-39
• Study Type: interventional
• Target: 812
• Locations: 3 countries
• Sites: 3

Brief Summary

This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.

Conditions

Pandemic Influenza

Keywords

Pandemic influenza vaccine

Outcome Measures

Primary Outcomes (1)

• To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults.

  43 days after first vaccination

Secondary Outcomes (1)

• 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

Study Arms (3)

low dose of antigen + low dose of adjuvant

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

high dose of antigen + high dose of adjuvant

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

high dose of antigen

EXPERIMENTAL

Biological: Monovalent A/H1N1 influenza vaccine

Interventions

Monovalent A/H1N1 influenza vaccine BIOLOGICAL

This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.

high dose of antigen; high dose of antigen + high dose of adjuvant; low dose of antigen + low dose of adjuvant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years of age and above on the day of enrollment;
• Individuals in good health
• Individuals 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.

You may not qualify if:

• Individual not able to comprehend and to follow all required study procedures;
• History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
• Any serious chronic or progressive disease according to judgment of the investigator
• History of any anaphylaxis, serious vaccine reactions, to any excipients.
• 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 participation in another clinical study through the end of this study;
• Any other vaccines within 4 weeks prior to enrollment or who are planning to receive any vaccine within 4 weeks from the study vaccines; only exception being plain seasonal influenza vaccines which are allowed until 1 week prior to and after 1 week study vaccinations.
• Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
• Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;
• Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;
• History of progressive or severe neurological disorders;
• Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
• Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;
• Female 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 the research staff or their relatives.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (3)

Unknown Facility

Gent, Antwerpen, Belgium

Location

Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg

München, Germany

Location

Unknown Facility

Zurich, Switzerland

Location

Related Publications (1)

• Hatz C, Cramer JP, Vertruyen A, Schwarz TF, von Sonnenburg F, Borkowski A, Lattanzi M, Hilbert AK, Cioppa GD, Leroux-Roels G. A randomised, single-blind, dose-range study to assess the immunogenicity and safety of a cell-culture-derived A/H1N1 influenza vaccine in adult and elderly populations. Vaccine. 2012 Jul 6;30(32):4820-7. doi: 10.1016/j.vaccine.2012.05.013. Epub 2012 May 22.

  PMID: 22626675 RESULT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: August 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: March 1, 2011
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

CH (1); DE (1); BE (1)