Safety and Immunogenicity of a Four Influenza Vaccines in Children Ages 6 Months Old to Less Than 48 Months Old

Phase 1

Completed

• Conditions: Influenza
• Interventions: Biological: Trivalent influenza vaccine-licensed; Biological: Trivalent influenza vaccine (TIVc)

• Registration Number: NCT02035696
• Lead Sponsor: Seqirus

Brief Summary

To evaluate the safety and immunogenicity of four influenza vaccines in children 6 months to \< 48 months of age

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-14
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Disposition First Submitted: 2015-02-06
• Disposition First Submitted QC: 2015-03-27
• Disposition First Posted: 2015-04-16
• Results First Submitted: 2015-08-19
• Results First Submitted QC: 2017-05-22
• Results First Posted: 2017-06-27
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVe	Trivalent influenza vaccine-licensed	Subjects (6 to \<48 months old) received two doses of TIVe vaccine(IM/0.25mL -for ages 6 to \<36 months and IM/ 0.5 mL -for ages 36 to \<48 months)
TIVc- Half Dose	Trivalent influenza vaccine (TIVc)	Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine
TIVc-High Dose	Trivalent influenza vaccine (TIVc)	Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine
TIVc-Full Dose	Trivalent influenza vaccine (TIVc)	Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine

Primary Outcome Measures

Name	Time	Method
Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 50/Day 1	Immunogenicity was assessed in terms of ratios of GMTs in subjects (6 to \<48 months old), measured by hemagglutination inhibition (HI) assay, day 1 to day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 50 post vaccination	Immunogenicity was assessed in terms number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI antibody titer, day 50 after vaccination with two doses of either TIVc or TIVe vaccine Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer
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	Day 1 to Day 3	Differences in percentages of subjects (6 to \<48 months old) with severe local solicited AEs and severe solicited systemic AEs, 3 days after vaccination with either TIVc or TIVe vaccine was assessed in terms of an individual desirability index score (High dose, Full dose, Half dose TIVc vs. TIVe vaccine). An individual desirability index score was assigned to each (non-transformed) safety value based on predefined functions. Each desirability index score is assigned a value between 0 and 1, wherein 0 is an undesirable response and 1 is a highly desirable response.

Secondary Outcome Measures

Name	Time	Method
Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 50 post vaccination	Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving seroconversion as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine; Seroconversion was defined as subjects with either a pre-vaccination (baseline) HI titer \< 1:10 and post-vaccination HI titer ≥ 1:40 or with a pre-vaccination HI titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination HI antibody titer; The Center for Biologics Evaluation, Research, and Review (CBER) criterion for pediatric population is that the lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%; The Committee for Medicinal Products for Human Use (CHMP) criterion for pediatric population is that the percentage of subjects achieving seroconversion or significant increase in HI antibody titers \>40%
Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 1, Day 50 post vaccination	Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving HI titer ≥1:40 as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine; The CBER criterion for pediatric population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%; The CHMP criterion for pediatric population is that the percentage of subjects achieving HI antibody titers ≥1:40 should be \>70%
Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 50 post vaccination over day 1	Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
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	Day 1 and Day 50 post vaccination	Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving post vaccination HI titers (i.e. HI titers ≥1:110, ≥1:150, ≥1:330 and ≥1:629) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 1 and Day 50 post vaccination	Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:20 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine; Post-vaccination MN titer ≥1:20 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 2-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine	Day 1 and Day 50 post vaccination	Immunogenicity was assessed in terms of number (%) of subjects (6 to \<48 months old) achieving MN titer ≥1:40 as measured by MN assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine; Post-vaccination MN titer ≥1:40 was defined as for subjects with baseline (day 1) MN titer \<1:10, or a minimum 4-fold increase in titer on day 50 for subjects with baseline titer ≥1:10 and corresponding 95% CI
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	Day 1 to Day 7	Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting solicited local and systemic reactions, day 1 to day 7 after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)
Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine	Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209	Safety was assessed in terms of number of subjects (6 to \<48 months old) reporting unsolicited reactions after Each /any Vaccination from Day 1 \[Post Vaccination\] to Day 29 \[Pre Clinic Visit\] and Day 29 \[Post Vaccination\] to Day 50 \[Pre Clinic Visit\] , Serious Adverse Events (SAEs), AEs leading to New Onset of Chronic Diseases (NOCD), AEs leading to withdrawal from the study and concomitant medications (day 1 to day 209) after vaccination with two doses of either TIVc or TIVe vaccine (By Any Vaccination)

Trial Locations

Locations (27)

Site 116; 🇺🇸 Phoenix, Arizona, United States

Site 119; 🇺🇸 Tucson, Arizona, United States

Site 109; 🇺🇸 Little Rock, Arkansas, United States

Site 112; 🇺🇸 Long Beach, California, United States

Site 113; 🇺🇸 Ontario, California, United States

Site 117; 🇺🇸 San Diego, California, United States

Site 114; 🇺🇸 West Covina, California, United States

Site 107; 🇺🇸 Thornton, Colorado, United States

Site 108; 🇺🇸 Miami Beach, Florida, United States

Site 111; 🇺🇸 Miami, Florida, United States

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