Phase 2
N=671
Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02035696 ↗Enrolled (actual)
671
Serious AEs
4.2%
Results posted
Jun 2017
Primary outcome: Primary: Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine — 7.82; 5.5; 5.93; 3.69 Ratios
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Trivalent influenza vaccine (TIVc) (Biological); Trivalent influenza vaccine-licensed (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Seqirus
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
7.82; 5.5; 5.93; 3.69; 10.53; 10.84 | — |
| PRIMARY Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine |
84; 80; 82; 73; 94; 91 | — |
| PRIMARY Desirability Index Score of Subjects (6 to <48 Months Old) Reporting Severe Solicited Local and Systemic Reactions After Vaccination With Either TIVc or TIVe Vaccine |
0.000; 0.000; 0.000; 0.040; 0.000; 0.000 | — |
| SECONDARY Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine |
84; 80; 82; 73; 94; 91 | — |
| SECONDARY Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
26; 32; 29; 26; 86; 85 | — |
| SECONDARY Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
7.84; 5.81; 5.98; 17.82; 8.4; 8.97 | — |
| SECONDARY Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
7.84; 5.81; 5.98; 17.82; 8.4; 8.97 | — |
| SECONDARY Percentages of Subjects (6 to <48 Months Old) With High Post Vaccination HI Titers (i.e. HI Titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) After Receiving Two Doses of Either TIVc or TIVe Vaccine |
26; 31; 26; 26; 78; 80 | — |
| SECONDARY Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
94; 93; 91; 97; 95; 94 | — |
| SECONDARY Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine |
87; 89; 84; 95; 85; 85 | — |
| SECONDARY Number of Subjects (6 to <48 Months Old) Reporting Solicited Local (Grading Type I) and Systemic Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine |
64; 56; 60; 54; 50; 43 | — |
| SECONDARY Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine |
102; 107; 91; 94; 38; 43 | — |
Summary
To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to < 48 months of age
Eligibility Criteria
Inclusion Criteria
- Healthy subject, male or female, 6 through < 48 months of age at the time of enrollment, who has never previously received an influenza vaccine
- Individual who has a parent or guardian that can give written informed consent after understanding the nature of the study and are available for follow-up
Exclusion Criteria
- Individuals recently vaccinated against influenza
- Subjects with contraindications to receive influenza vaccine
Data sourced from ClinicalTrials.gov (NCT02035696). 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.