Phase 3
N=3,317
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT00764790 ↗Enrolled (actual)
3,317
Serious AEs
2.9%
Results posted
Jul 2010
Primary outcome: Primary: Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains — 10.4; 10.6; 10.9; 106.1 titre
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluarix (Biological); Fluzone (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains |
10.4; 10.6; 10.9; 106.1; 131.6; 232.4 | — |
| PRIMARY Number of Subjects Who Seroconverted |
636; 699; 929; 747; 808; 988 | — |
| SECONDARY Number of Seroprotected Subjects |
185; 186; 206; 699; 754; 986 | — |
| SECONDARY Seroconversion Factor |
10.2; 12.4; 21.4; 10.4; 14.2; 24.1 | — |
| SECONDARY Number of Subjects Reporting Solicited Local Symptoms |
403; 406; 363; 259; 249; 253 | — |
| SECONDARY Number of Subjects Reporting Solicited General Symptoms |
293; 317; 298; 386; 387; 375 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events (AE) |
565; 541; 562 | — |
| SECONDARY Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD) |
35; 29; 31; 10; 8; 9 | — |
| SECONDARY Number of Subjects Reporting Rare Serious Events |
0; 0; 3; 0; 3; 3 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00764790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.