Phase 2
Completed N=374
Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Source: ClinicalTrials.gov NCT00778895 ↗Enrolled (actual)
374
Serious AEs
1.1%
Results posted
Jul 2013
Primary outcomePrimary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination — 45; 55; 1; 1 Participants
Summary
Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination |
17; 0; 13; 0; 5; 0 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination |
16; 0; 11; 22; 1; 15 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination |
24; 3; 8 | — |
| PRIMARY Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination |
14 | — |
| PRIMARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination |
0; 0 | — |
| SECONDARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies |
8.3; 8.5; 8.1; 56.3; 70.7; 120.9 | — |
| SECONDARY Number of Subjects Seroconverted to HI Antibodies |
67; 82; 29; 81; 98; 28 | — |
| SECONDARY Number of Subjects Seroprotected Against HI Antibodies |
17; 21; 5; 70; 84; 30 | — |
| SECONDARY Seroconversion Factor for HI Antibodies |
6.8; 8.3; 14.9; 9.2; 9.7; 13.3 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination |
17; 0; 13; 0; 5; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination |
16; 0; 11; 22; 1; 15 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination |
24; 3; 8 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination |
14 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female child 6 months to < 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
- Subjects must be in good health established by medical history and physical examination before entering into the study;
- Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
- Written informed consent obtained from the subject's parent/guardian.
- Parents/guardian access to a consistent means of telephone contact, land line or mobile
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 to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
- History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
- Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
- Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
- Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
- Any use of analgesics/antipyretics 12 hours before receipt of vaccine.
Data sourced from ClinicalTrials.gov (NCT00778895). 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. Informational only — not medical advice.