NCT03460743

Brief Summary

Multicentric study, Phase III; this study is a randomized, participant- and observer-blind, parallel group evaluation to evaluate the immunogenicity, relative efficacy, safety and reactogenicity of a recombinant quadrivalent hemagglutinin influenza vaccine versus an inactivated quadrivalent influenza vaccine in pediatric subjects and adolescents of 3-17 years of age. Investigational vaccine is indicated for active immunization against influenza A and B for strains contained in the vaccine marketed in the United States for persons 18 years of age or older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,556

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

March 22, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2019

Completed
Last Updated

November 13, 2019

Status Verified

November 1, 2019

Enrollment Period

1.6 years

First QC Date

March 4, 2018

Last Update Submit

November 12, 2019

Conditions

Influenza, Human

Keywords

hemagglutinin influenza vaccinerecombinant influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • Seroconversion

    Proportion of subjects with seroconversion defined as (a) a \>4-fold rise in HAI antibody titer in subjects seropositive (titer \>10) at baseline or (b) an HAI titer of \>40 in those seronegative at baseline.

    To be evaluated against each of the 4 vaccine antigens, on Day 28 (or Day 56 for 2-dose subjects), by category aged

Study Arms (2)

Study group

EXPERIMENTAL

single or two doses of quadrivalent recombinant 180 ugm hemagglutinin influenza vaccine

Biological: Study group - quadrivalent recombinant hemagglutinin influenza vaccine

Control group

ACTIVE COMPARATOR

single or two doses of quadrivalent inactivated influenza vaccine.

Biological: Control group - quadrivalent inactivated influenza vaccine

Interventions

Study group - quadrivalent recombinant hemagglutinin influenza vaccineBIOLOGICAL

Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.

Study group
Control group - quadrivalent inactivated influenza vaccineBIOLOGICAL

Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.

Control group

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female age 3 to 17 years.
  • History of two previous influenza immunizations at any time, or influenza infection during the previous year.
  • Female subjects of child-bearing potential (as defined by the onset of menses) must agree to prevent pregnancy and usage of an effective contraception, or having practiced sexual abstinence for at least 28 day prior to the first study vaccine administration. Female subjects of child-bearing potential must be tested for pregnancy within 24 hours prior to vaccine administration.
  • In good general health, healthy or medically stable, as determined by the medical history, physical examination and the Investigator's judgment.
  • Parent(s) or legal representative of each potential subject must comprehend the study requirements, sign the informed consent before any procedure, and agree to comply with planned study procedures and visits. Provide written consent prior to enrollment and initiation of any study procedure.
  • Pediatric consent will be attained as per the Research Ethics Committee's determination when subject is aged 8 or older.

You may not qualify if:

  • Known allergy to eggs (anaphylaxis, angioedema, respiratory distress), severe allergy (e.g. anaphylaxis) to other components of the vaccine or contraindications to receive the comparator IIV4.
  • Use of systemic steroids at doses of 2mg/kg/day for more than 10 days of prednisone or its equivalent.
  • (The use of nasal or topical steroids will be allowed).
  • Active neoplastic disease or a history of any malignancy.
  • History of receiving the influenza vaccine within the previous 6 months.
  • Plan to receive another influenza vaccine, during the study term.
  • History of receiving immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
  • Acute or chronic medical condition that, in the opinion of the Investigator, would render immunization unsafe or would interfere with the evaluation of efficacy or the immune response to the vaccine.
  • An acute illness, including a body temperature greater than 37.7°C, within 3 days prior to immunization.
  • Receive an experimental vaccine or medication within 1 month prior to enrollment in this study, or the expectation to receive an experimental vaccine, medication, or blood product during the study period.
  • History of Guillain-Barré syndrome within 6 weeks after the application a previous influenza vaccine.
  • Concurrent participation in another clinical trial (active or follow-up phase).
  • Any other condition or situation that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinical Research Institute Saltillo

Saltillo, Coahuila, 25020, Mexico

Location

Centro de Investigacion Clinica del Pacifico

Acapulco de Juárez, Guerrero, 39670, Mexico

Location

AMIC Pachuca

Pachuca, Hidalgo, 42070, Mexico

Location

Instituto Jalisciencie de Metabolismo

Guadalajara, Jalisco, 44670, Mexico

Location

AINPAD Morelia

Morelia, Michoacán, 58070, Mexico

Location

JM Research

Cuernavaca, Morelos, 62290, Mexico

Location

Instituto Nacional de Pediatria

Mexico City, 04530, Mexico

Location

CEMDEC

Mexico City, 06100, Mexico

Location

Clinical Research Institute Darwin

Mexico City, 11590, Mexico

Location

UDEP Puebla

Puebla City, 72160, Mexico

Location

Centro Especializado en Investigación Clínica CEIC

Veracruz, 94290, Mexico

Location

Related Publications (2)

  • King JC Jr, Cox MM, Reisinger K, Hedrick J, Graham I, Patriarca P. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy children aged 6-59 months. Vaccine. 2009 Nov 5;27(47):6589-94. doi: 10.1016/j.vaccine.2009.08.032. Epub 2009 Aug 27.

    PMID: 19716456BACKGROUND

  • Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immunogenicity of FluBlok(R) trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine. 2011 Mar 9;29(12):2272-8. doi: 10.1016/j.vaccine.2011.01.039. Epub 2011 Jan 28.

    PMID: 21277410BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Mercedes Macias, MD

    National Institute of Pediatrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participant- and observer-blind, the vaccine will be administered by a non-blinded vaccinator that will not participate in the clinical evaluation.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Visit 1: screening visit, baseline blood sampling and administration of the study vaccine that can be performed on Day 0. Visit 1A and 2: Remote follow up contacts on day 2 and 7 post-vaccination. Visit 3: i. Follow up and blood sampling (for the 1-dose group); ii. Visit 3A, follow-up and application of the second dose of the vaccine (for the corresponding group); iii. Visit 3B, follow-up and blood sampling for the 2-dose group. The visits occur on Day 28. Months 3, 4, 5: Remote Contacts for safety tracking Visit 4: Remote contact for study closure and safety tracking at Month 6
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2018

First Posted

March 9, 2018

Study Start

March 22, 2018

Primary Completion

October 22, 2019

Study Completion

October 22, 2019

Last Updated

November 13, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

ME(11)