Phase 3
N=2,333
Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01992107 ↗Enrolled (actual)
2,333
Serious AEs
0.7%
Results posted
Dec 2015
Primary outcome: Primary: Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c — 96; 100; NA; 1090 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- QIVc (Biological); TIV1c (Biological); TIV2c (Biological)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c |
96; 100; NA; 1090; 1125; NA | — |
| PRIMARY Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c |
72; 75; NA; 47; 51; NA | — |
| SECONDARY Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years |
73; 74; NA; 47; 51; NA | — |
| SECONDARY Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years |
76; 79; NA; 99; 99; NA | — |
| SECONDARY Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years |
73; 74; NA; 47; 51; NA | — |
| SECONDARY Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years |
76; 79; NA; 99; 99; NA | — |
| SECONDARY Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age |
11; 12; NA; 3.65; 3.97; NA | — |
| SECONDARY GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain |
22; 21; 176; 45 | — |
| SECONDARY Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c |
73; 26 | — |
| SECONDARY GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain |
25; 24; 154; 59 | — |
| SECONDARY Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c |
67; 33 | — |
| SECONDARY Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata |
103; 51; 47; 52; 17; 17 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group |
279; 139; 152; 56; 34; 31 | — |
Summary
Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.
Eligibility Criteria
Inclusion Criteria
- Male or female aged 4 years to less than 18 years of age.
- Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
- If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.
Exclusion Criteria
- Individuals recently vaccinated against influenza
- Subjects with contraindications to receive influenza vaccine
Data sourced from ClinicalTrials.gov (NCT01992107). 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.