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

Influenza Clinical Trial

Official title:

A Phase I/II, Randomized, Observer-Blind, Multicenter Study to Evaluate Immunogenicity and Safety of Four Influenza Vaccines in Healthy Pediatric Subjects 6 to < 48 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02035696
• Other study ID #: V58P16
• Secondary ID: 2013-002081-39
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: June 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 671
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 48 Months

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent influenza vaccine (TIVc)

• Trivalent influenza vaccine-licensed
Licensed influenza vaccine

Locations

Country	Name	City	State
Finland	Site 502	Kuopio
Finland	Site 506	Tampere
Philippines	Site 301	Manila
Philippines	Site 302	Muntinlupa
Thailand	Site 201	Bangkok
Thailand	Site 202	Bangkok
United States	Site 102	Charleston	South Carolina
United States	Site 121	Gainesville	Georgia
United States	Site 115	Houston	Texas
United States	Site 109	Little Rock	Arkansas
United States	Site 112	Long Beach	California
United States	Site 111	Miami	Florida
United States	Site 108	Miami Beach	Florida
United States	Site 101	Omaha	Nebraska
United States	Site 104	Omaha	Nebraska
United States	Site 105	Omaha	Nebraska
United States	Site 106	Omaha	Nebraska
United States	Site 113	Ontario	California
United States	Site 116	Phoenix	Arizona
United States	Site 118	Saint George	Utah
United States	Site 110	Salt Lake City	Utah
United States	Site 117	San Diego	California
United States	Site 120	Spokane	Washington
United States	Site 107	Thornton	Colorado
United States	Site 119	Tucson	Arizona
United States	Site 114	West Covina	California
United States	Site 103	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Seqirus	Novartis Vaccines

Countries where clinical trial is conducted

United States,  Finland,  Philippines,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 50/Day 1
Primary	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	Day 50 post vaccination
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	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.	Day 1 to Day 3
Secondary	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%	Day 50 post vaccination
Secondary	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%	Day 1, Day 50 post vaccination
Secondary	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	Day 50 post vaccination over day 1
Secondary	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	Day 50 post vaccination over day 1
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	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	Day 1 and Day 50 post vaccination
Secondary	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	Day 1 and Day 50 post vaccination
Secondary	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	Day 1 and Day 50 post vaccination
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	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)	Day 1 to Day 7
Secondary	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)	Unsolicited AEs after Each/any Vaccination from Day 1 to Day 29 and Day 29 to Day 50 , Day 1 to Day 209