Phase 4
N=402
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Influenza, Human
Bottom Line
View on ClinicalTrials.gov: NCT02212106 ↗Enrolled (actual)
402
Serious AEs
0.3%
Results posted
Oct 2015
Primary outcome: Primary: The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine. — 8.2; 4.1; 2.1; 2.1 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) (Biological); Comparator Quadrivalent Influenza Virus Vaccine (Biological)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine. |
8.2; 4.1; 2.1; 2.1 | — |
| SECONDARY The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine. |
9.2; 1.0; 4.1; 4.1 | — |
| SECONDARY The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine. |
7.5; 5.1; 4.1; 1.0; 1.7; 4.1 | — |
| SECONDARY The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. |
70.2; 68.4; 49.8; 46.9; 17.2; 15.3 | — |
| SECONDARY The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. |
40.8; 44.9; 28.4; 21.4; 8.6; 19.4 | — |
| SECONDARY The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine. |
14.0; 22.4; 8.2; 12.2; 5.8; 10.2 | — |
| SECONDARY The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine. |
1; 0 | — |
Summary
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.
Eligibility Criteria
Inclusion Criteria
- Males or females aged 5 to less than 9 years at the time of first study vaccination.
- The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
- In good health, as determined by medical history and a targeted physical examination (if warranted).
Exclusion Criteria
- Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
- Clinical signs of significant active infection or an elevated oral temperature at study entry.
- A clinically significant medical or psychiatric condition.
- A history of seizures or febrile convulsions or Guillain-Barré syndrome.
- Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
- Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
- Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
- Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
- Currently receiving treatment with warfarin or other anticoagulants.
Data sourced from ClinicalTrials.gov (NCT02212106). 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.