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

NCT ID: NCT00970177

Last Updated: 2016-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

low dose of antigen + low dose of adjuvant

Group Type: EXPERIMENTAL

Monovalent A/H1N1 influenza vaccine

Intervention Type: 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 adjuvant

Group Type: EXPERIMENTAL

Monovalent A/H1N1 influenza vaccine

Intervention Type: 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

Group Type: EXPERIMENTAL

Monovalent A/H1N1 influenza vaccine

Intervention Type: 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.

Interventions

Monovalent A/H1N1 influenza vaccine

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Males and females 18 years of age and above on the day of enrollment;

2. Individuals in good health

3. Individuals are able to comply with all study procedures

4. 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. Individual not able to comprehend and to follow all required study procedures;

2. 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;

3. Any serious chronic or progressive disease according to judgment of the investigator

4. History of any anaphylaxis, serious vaccine reactions, to any excipients.

5. 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 participation in another clinical study through the end of this study;

7. 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.

8. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;

9. Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination;

10. Known or suspected impairment/alteration of immune function, for example resulting from a receipt of immunosuppressive therapy within 60 days prior to Visit 1;

11. History of progressive or severe neurological disorders;

12. Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;

13. Female of childbearing potential, not used any acceptable contraceptive methods for at least 2 months prior to study entry;

14. 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;

15. Members of the research staff or their relatives.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gent, Antwerpen, , Belgium

Wurzburg, Fulda, Neumunster, Balve, Leipzig, Magdeburg

München, , Germany

Zurich, , Switzerland

Countries

Netherlands; Belgium; Germany; Switzerland

References

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.

Reference Type: RESULT

PMID: 22626675 (View on PubMed)

Other Identifiers

2009-013639-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V110_03

Identifier Type: -

Identifier Source: org_study_id