NCT01942265

Brief Summary

This Phase II randomized, double-blinded, controlled study in up to 1000 males and non-pregnant females, 19 to 64 years old, inclusive, who are in good health and meet all eligibility criteria is designed to provide data on an A/H7N9 vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
980

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

5 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

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 6, 2017

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

September 4, 2013

Last Update Submit

July 3, 2017

Conditions

Influenza

Keywords

Influenza, Immunogenicity, Monovalent, A/H7N9, Vaccine, AS03, Adjuvant

Outcome Measures

Primary Outcomes (5)

  • Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer).

    Day 42 (21 days post second study vaccination)

  • Occurrence of solicited injection site and systemic reactogenicity on the day of each study vaccination through 7 days after each study vaccination.

    Day 0 though Day 29

  • Occurrence of study vaccine-related serious adverse events from the time of the first study vaccination through approximately 13 months after the first study vaccination.

    Day 0 through Day 386

  • Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the A/H7N9 antigen contained in the study vaccine at approximately 21 days after the second study vaccination.

    Day 42 (21 days post second study vaccination)

  • Occurrence of clinical safety laboratory adverse events from the time of each study vaccination through approximately 8 days after each study vaccination.

    Day 0 through Day 29

Secondary Outcomes (9)

  • Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer)

    Day 0, 8 and 21

  • Percentage of subjects achieving seroconversion (defined as either a pre-vaccination Neut titer <1:10 and a post-vaccination Neut titer >/= 1:40 or a pre-vaccination Neut titer >/=1:10 and a minimum four-fold rise in post-vaccination Neut antibody titer)

    Day 0, 8, 21, 29, and 42

  • Percentage of subjects achieving seroconversion (defined as either a pre-vaccination HAI titer <1:10 and a post-vaccination HAI titer >/=1:40 or a pre-vaccination HAI titer >/=1:10 and a minimum four-fold rise in post-vaccination HAI antibody titer).

    Day 29 (8 days after the second study vaccination)

  • Occurrence of unsolicited adverse events from the time of the first study vaccination through approximately 21 days after the last study vaccination.

    Day 42 (21 days post last study vaccination

  • Geometric Mean Titers of serum HAI and Neut antibody at baseline and at approximately 8 and 21 days after each study vaccination.

    Days 0, 8, 21, 29, and 42

  • +4 more secondary outcomes

Study Arms (10)

Group 4

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen on Day 21

Drug: AS03Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 3

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21

Drug: AS03Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 1

EXPERIMENTAL

100 subjects receive 3.75mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21

Drug: AS03Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 2

EXPERIMENTAL

100 subjects receive 7.5mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 21

Drug: AS03Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 5

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen on Day 0 and 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 21

Drug: AS03Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 9

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen on Day 0 and 21

Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 8

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 0 and 21

Drug: MF59Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 7

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 21

Drug: AS03Drug: MF59Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 6

EXPERIMENTAL

100 subjects receive 15mcg sanofi A/H7N9 antigen plus GSK AS03 adjuvant on Day 0 and 15mcg sanofi A/H7N9 antigen plus NVD MF59 adjuvant on Day 21

Drug: AS03Drug: MF59Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Group 10

EXPERIMENTAL

100 subjects receive 45 mcg sanofi A/H7N9 antigen on Day 0 and 21

Biological: Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Interventions

AS03DRUG

Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.

Group 1Group 2Group 3Group 4Group 5Group 6Group 7
MF59DRUG

Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.

Group 6Group 7Group 8
Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013BIOLOGICAL

Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.

Group 1Group 10Group 2Group 3Group 4Group 5Group 6Group 7Group 8Group 9

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Provide written informed consent prior to initiation of any study procedures.
  • Are able to understand and comply with planned study procedures and be available for all study visits.
  • Are males or non-pregnant females, 19 to 64 years old, inclusive.

You may not qualify if:

  • Oral temperature is less than 100.4 degrees F.
  • Pulse is 50 to 115 bpm, inclusive.
  • Systolic blood pressure is 85 to 150 mm Hg, inclusive.
  • Diastolic blood pressure is 55 to 95 mmHg, inclusive.
  • Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour.
  • Alanine aminotransferase (ALT) is less than 44 IU/L for females or is less than 61 IU/L for males.
  • Creatinine is less than 1.11 mg/dL for females or is less than 1.38 mg/dL for males.
  • White blood cells (WBC) are greater than 3.9 x10\^3/UL and less than 10.6 x10\^3/UL.
  • Hemoglobin is greater than 11.4 g/dL for females or is greater than 12.4 g/dL for males.
  • Platelets are greater than 139 x10\^3/UL and less than 416 x10\^3/UL.
  • Total bilirubin is less than 1.3 mg/dL.
  • Female subjects of childbearing potential who are not surgically sterile via tubal sterilization, bilateral oophorectomy, or hysterectomy or who are not postmenopausal for \>/= 1 year must agree to practice highly effective contraception that may include, but is not limited to, abstinence from intercourse with a male partner, monogamous relationship with a vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods with use of a highly effective method of contraception for a minimum of 30 days prior to study product exposure and agree to practice highly effective contraception for the duration of study product exposure, including 2 months (defined as 60 days) after the last study vaccination. A highly effective method of contraception is defined as one which results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. Method of contraception will be captured on the appropriate data collection form.
  • Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination.
  • Have an acute illness within 72 hours prior to study vaccination.
  • Have any condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or confound the interpretation of the results.
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Baltimore, Maryland, 21201-1509, United States

Location

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104-1015, United States

Location

Vanderbilt University Medical Center - Infectious Diseases

Nashville, Tennessee, 37232-0011, United States

Location

Baylor College of Medicine - Molecular Virology and Microbiology

Houston, Texas, 77030-3411, United States

Location

Group Health Research Institute - Seattle - Vaccines and Infectious Diseases

Seattle, Washington, 98101-1466, United States

Location

Related Publications (1)

  • Jackson LA, Campbell JD, Frey SE, Edwards KM, Keitel WA, Kotloff KL, Berry AA, Graham I, Atmar RL, Creech CB, Thomsen IP, Patel SM, Gutierrez AF, Anderson EL, El Sahly HM, Hill H, Noah DL, Bellamy AR. Effect of Varying Doses of a Monovalent H7N9 Influenza Vaccine With and Without AS03 and MF59 Adjuvants on Immune Response: A Randomized Clinical Trial. JAMA. 2015 Jul 21;314(3):237-46. doi: 10.1001/jama.2015.7916.

    PMID: 26197184RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

MF59 oil emulsionInfluenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

September 13, 2013

Study Start

September 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 6, 2017

Record last verified: 2014-09

Locations

US(5)