Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00703651
First received: June 19, 2008
Last updated: June 20, 2008
Last verified: June 2008
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Purpose
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Orthomyxoviridae Infection Myxovirus Infection |
Biological: Inactivated, split-virion influenza vaccine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults |
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 Sanofi:
Primary Outcome Measures:
- To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. [ Time Frame: 21days post-vaccination ] [ Designated as safety issue: No ]
- To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine [ Time Frame: 21 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
| Enrollment: | 1150 |
| Study Start Date: | September 2003 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years
|
| Experimental: 2 |
Biological: Inactivated, split-virion influenza vaccine
0.1 mL, ID. 1 injection/year for 3 years.
|
| Active Comparator: 3 |
Biological: Inactivated, split-virion influenza vaccine
0.5 mL, IM. 1 injection/year for 3 years
Other Name: Vaxigrip®
|
Detailed Description:
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
Eligibility| Ages Eligible for Study: | 18 Years to 57 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria :
- Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
- For woman of child-bearing potential, negative urine pregnancy test at V#01
- Use of effective contraception prior to and during the trial
- Subject available during the trial period
- Subject able to read and understand the informed consent form
- Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).
Exclusion Criteria :
- Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
- Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
- Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
- Vaccination against influenza within the 6 months preceding V#01
- Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
- Breast-feeding
- Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing
- Immunoglobulin injection within the 3 months preceding V#01
- Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
- Subject having received extracted pituitary hormones
- Subjects who participated in the GID01 study (Lithuanian centers)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703651
Locations
| Belgium | |
| Gribomont, Belgium | |
| Kraainem, Belgium | |
| Linkebeek, Belgium | |
| Molenbeek, Belgium | |
| Thuin, Belgium | |
| Czech Republic | |
| Hradec Kralove, Czech Republic | |
| Lithuania | |
| Kaunas, Lithuania | |
| Vilnius, Lithuania | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Monitor | Sanofi Pasterur Inc |
More Information
Additional Information:
No publications provided by Sanofi
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00703651 History of Changes |
| Other Study ID Numbers: | GID02 |
| Study First Received: | June 19, 2008 |
| Last Updated: | June 20, 2008 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Czech Republic: State Institute for Drug Control Lithuania: State Medicine Control Agency - Ministry of Health |
Keywords provided by Sanofi:
|
Influenza Orthomyxoviridae Infection Inactivated, Split-virion influenza vaccine Intradermal injection Adults. |
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