Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
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Purpose
The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza |
Biological: Fluarix Biological: Fluzone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children |
- Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ] [ Designated as safety issue: No ]
GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
- Number of Subjects Who Seroconverted [ Time Frame: Day 28 or Day 56 ] [ Designated as safety issue: No ]
Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
- Number of Seroprotected Subjects [ Time Frame: Day 0 (PRE), Day 28 or Day 56 (POST) ] [ Designated as safety issue: No ]
A seroprotected subject is a subject with a serum anti-HA titer
≥ 1:40
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
- Seroconversion Factor [ Time Frame: Day 28 or Day 56 ] [ Designated as safety issue: No ]
Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).
Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
- Number of Subjects Reporting Solicited Local Symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]Solicited local symptoms assessed include pain, redness and swelling.
- Number of Subjects Reporting Solicited General Symptoms [ Time Frame: During a 4-day follow-up period after vaccination ] [ Designated as safety issue: No ]Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
- Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During a 28-day follow-up period after vaccination ] [ Designated as safety issue: No ]An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
- Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) [ Time Frame: During the entire study (Day 0 until Month 6) ] [ Designated as safety issue: No ]
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
- Number of Subjects Reporting Rare Serious Events [ Time Frame: During the entire study (Day 0 until Month 6) ] [ Designated as safety issue: No ]Rare serious events have an occurrence rate of 1/300 (0.3%).
| Enrollment: | 3317 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fluarix Dose A Group
Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
Biological: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
|
|
Experimental: Fluarix Dose B Group
Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
Biological: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
|
|
Active Comparator: Fluzone Group
Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age). * Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses. |
Biological: Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
|
Eligibility| Ages Eligible for Study: | 6 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject's parent/guardian.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Receipt of an influenza vaccine outside of this study, during current (2008-09) flu season.
- Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
Contacts and Locations
Show 65 Study Locations| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00764790 History of Changes |
| Other Study ID Numbers: | 111751 |
| Study First Received: | October 1, 2008 |
| Results First Received: | February 25, 2010 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Taiwan: Department of Health Thailand: Ministry of Public Health Hong Kong: Department of Health Mexico: Ministry of Health United States: Food and Drug Administration |
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 21, 2013