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

Phase 2CompletedNCT02035696

Seqirus671 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

671

Conditions

Influenza

Interventions

Trivalent influenza vaccine (TIVc)BIOLOGICAL

Trivalent influenza vaccine-licensedBIOLOGICAL

Licensed influenza vaccine

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 48 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (27)

Site 116

Phoenix, Arizona, United States

Site 119

Outcomes

Primary Outcomes

Ratios of Geometric Mean Titer (GMT) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine

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

Time frame: Day 50/Day 1

Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine

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

Time frame: Day 50 post vaccination

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

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.

Time frame: Day 1 to Day 3

Secondary Outcomes

Percentages of Subjects (6 to <48 Months Old) Achieving Seroconversion or Significant Increase After Receiving Two Doses of Either TIVc or TIVe Vaccine

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%

Data from ClinicalTrials.gov

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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 111

Miami, Florida, United States

Site 108

Miami Beach, Florida, United States

...and 17 more locations

Time frame: Day 50 post vaccination

Percentages of Subjects (6 to <48 Months Old) Achieving HI Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine

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%

Time frame: Day 1, Day 50 post vaccination

Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine

Immunogenicity was assessed in terms of GMR in subjects (6 to \<48 months old) as measured by HI assay, day 50 after vaccination with two doses of either TIVc or TIVe vaccine The CHMP criterion is mean geometric ratio (GMR) \>2.5

Time frame: Day 50 post vaccination over day 1

Geometric Mean Ratios (GMR) in Subjects (6 to <48 Months Old) After Receiving Two Doses of Either TIVc or TIVe Vaccine

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

Time frame: Day 50 post vaccination over day 1

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

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

Time frame: Day 1 and Day 50 post vaccination

Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:20 After Receiving Two Doses of Either TIVc or TIVe Vaccine

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

Time frame: Day 1 and Day 50 post vaccination

Percentages of Subjects (6 to <48 Months Old) Achieving MN Titer ≥1:40 After Receiving Two Doses of Either TIVc or TIVe Vaccine

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

Time frame: Day 1 and Day 50 post vaccination

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

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)

Time frame: Day 1 to Day 7

Number of Subjects (6 to <48 Months Old) Reporting Unsolicited Adverse Events (AEs) After Two Doses of Either TIVc or TIVe Vaccine

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)

Time frame: Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209