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

NCT02035696 | Completed Phase 1 Results DMC

• 2 other identifiers: V58P162013-002081-39
• Study Type: interventional
• Target: 671
• Locations: 4 countries
• Sites: 27

Brief Summary

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

Conditions

Influenza

Keywords

influenza; children; safety; tolerability; immunogenicity

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (9)

• 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

• 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

• 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

• 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

• 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

Study Arms (4)

TIVc-High Dose

EXPERIMENTAL

Subjects (6 to \<48 months old) received two doses of 0.75 mL of TIVc vaccine

Biological: Trivalent influenza vaccine (TIVc)

TIVc-Full Dose

EXPERIMENTAL

Subjects(6 to \<48 months old) received two doses of 0.50 mL of TIVc vaccine

Biological: Trivalent influenza vaccine (TIVc)

TIVc- Half Dose

EXPERIMENTAL

Subjects (6 to \<48 months old)received two doses of 0.25 mL of TIVc vaccine

Biological: Trivalent influenza vaccine (TIVc)

TIVe

ACTIVE COMPARATOR

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)

Biological: Trivalent influenza vaccine-licensed

Interventions

Trivalent influenza vaccine (TIVc) BIOLOGICAL

TIVc- Half Dose; TIVc-Full Dose; TIVc-High Dose

Trivalent influenza vaccine-licensed BIOLOGICAL

Licensed influenza vaccine

TIVe

Eligibility Criteria

• Age: 6 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Individuals recently vaccinated against influenza
• Subjects with contraindications to receive influenza vaccine

Sponsors & Collaborators

• Seqirus: lead
• Novartis Vaccines: collaborator

Study Sites (27)

Site 116

Phoenix, Arizona, United States

Location

Site 119

Tucson, Arizona, United States

Location

Site 109

Little Rock, Arkansas, United States

Location

Site 112

Long Beach, California, United States

Location

Site 113

Ontario, California, United States

Location

Site 117

San Diego, California, United States

Location

Site 114

West Covina, California, United States

Location

Site 107

Thornton, Colorado, United States

Location

Site 111

Miami, Florida, United States

Location

Site 108

Miami Beach, Florida, United States

Location

Site 121

Gainesville, Georgia, United States

Location

Site 101

Omaha, Nebraska, United States

Location

Site 104

Omaha, Nebraska, United States

Location

Site 105

Omaha, Nebraska, United States

Location

Site 106

Omaha, Nebraska, United States

Location

Site 103

Youngstown, Ohio, United States

Location

Site 102

Charleston, South Carolina, United States

Location

Site 115

Houston, Texas, United States

Location

Site 110

Salt Lake City, Utah, United States

Location

Site 118

St. George, Utah, United States

Location

Site 120

Spokane, Washington, United States

Location

Site 502

Kuopio, Finland

Location

Site 506

Tampere, Finland

Location

Site 302

City of Muntinlupa, Philippines

Location

Site 301

Manila, Philippines

Location

Site 201

Bangkok, Thailand

Location

Site 202

Bangkok, Thailand

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 14, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 10, 2018
• Results First Posted: June 27, 2017

Record last verified: 2018-06

Locations

US (21); FI (2); PH (2); TH (2)