Phase 4
Completed N=224
Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Source: ClinicalTrials.gov NCT00372255 ↗Enrolled (actual)
224
Serious AEs
1.3%
Results posted
May 2019
Primary outcomePrimary: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years — 290.4; 719.2; 381.2; 393.9 Titer
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years |
290.4; 719.2; 381.2; 393.9; 97.7; 301.8 | — |
| PRIMARY Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years |
16.7; 40.7; 14.9; 15.4; 8.5; 26.1 | — |
| PRIMARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years |
63; 93; 79; 80; 66; 92 | — |
| SECONDARY Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years |
1326.6; 300.6; 218.9 | — |
| SECONDARY SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years |
50.2; 10.3; 12.6 | — |
| SECONDARY Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years |
90; 83; 90 | — |
| SECONDARY Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years |
33; 52; 62 | — |
| SECONDARY Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years |
91; 101; 93 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
62; 54; 0; 1; 28; 24 | — |
| SECONDARY Number of Subjects With Solicited General Symptoms |
10; 6; 0; 1; 9; 6 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events. |
52; 30; 3; 1; 1; 4 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
3; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
- All subjects must not have received a prior influenza vaccination.
- All subjects must not have had a prior influenza disease.
Exclusion Criteria
- Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
- Acute illness at the start of the study.
- Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
- Known allergic reactions which might be caused by the ingredients of the vaccine.
- Girls post-menarche: pregnancy or positive pregnancy-test
- Multiple sclerosis or congenital or acquired immunodeficiencies.
Data sourced from ClinicalTrials.gov (NCT00372255). 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.