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:
Novartis Vaccines
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pandemic Influenza |
Biological: Monovalent A/H1N1 influenza vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Flu
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 778 |
| Study Start Date: | September 2009 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 6 Months to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971542
Locations
| Belgium | |
| Gent, Antwerpen, Belgium | |
| Chile | |
| Santigo de chile | |
| Santiago, Chile | |
| Dominican Republic | |
| Gazcue Santo Domingo | |
| Gazcue Santo Domingo, Dominican Republic | |
| Germany | |
| Wurzburg, Fulda, Neumunster, Balve, Stuttgart-Feuerbach, Leipzig, Rostock, Mainz, Detmold, Alsfeld | |
| Mainz, Germany | |
| Netherlands | |
| Rotterdam, Netherlands | |
Sponsors and Collaborators
Novartis Vaccines
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00971542 History of Changes |
| Other Study ID Numbers: | V111_03, 2009-013672-45 |
| Study First Received: | September 2, 2009 |
| Last Updated: | October 10, 2011 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Novartis:
|
Pandemic influenza Vaccine |
Additional relevant MeSH terms:
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013