NCT02985320

Brief Summary

The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
708

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 26, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

December 5, 2016

Last Update Submit

July 25, 2017

Conditions

Poliomyelitis

Keywords

Sabin strainInactivated poliovirus vaccinepoliomyelitissafetyimmunogenicityinfant

Outcome Measures

Primary Outcomes (3)

  • The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen

    Subjects whose pre-immune antibody level \< 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.

    90 days

  • The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen

    GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.

    90 days

  • The geometric mean fold increase (GMI) of each group after three-dose regimen

    The GMI is the increase of post-immune GMT from pre-immune GMT.

    90 days

Secondary Outcomes (3)

  • The incidences of solicited adverse events (AEs) of each group in both phase I and II trials

    7 days

  • The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials

    30 days

  • The incidences of serious adverse events (SAEs) of each group in both phase I and II trials

    30 days

Study Arms (12)

Phase I Adult Group - High dosage

EXPERIMENTAL

* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV

Biological: Single-dose regimen of high dosage investigational sIPV

Phase I Adult Group - Medium dosage

EXPERIMENTAL

* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV

Biological: Single-dose regimen of medium dosage investigational sIPV

Phase I Child Group - High dosage

EXPERIMENTAL

* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV

Biological: Single-dose regimen of high dosage investigational sIPV

Phase I Child Group - Medium dosage

EXPERIMENTAL

* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV

Biological: Single-dose regimen of medium dosage investigational sIPV

Phase I Infant Group - High dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV

Biological: Three-dose regimen of high dosage investigational sIPV

Phase I Infant Group - Medium dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV

Biological: Three-dose regimen of medium dosage investigational sIPV

Phase I Infant Group - Low dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV

Biological: Three-dose regimen of low dosage investigational sIPV

PhaseⅡExperimental Group - High dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV

Biological: Three-dose regimen of high dosage investigational sIPV

PhaseⅡExperimental Group - Medium dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV

Biological: Three-dose regimen of medium dosage investigational sIPV

PhaseⅡExperimental Group - Low dosage

EXPERIMENTAL

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV

Biological: Three-dose regimen of low dosage investigational sIPV

PhaseⅡControl Group -commercialized sIPV

ACTIVE COMPARATOR

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention:Three-dose regimen of commercialized sIPV

Biological: Three-dose regimen of commercialized sIPV

PhaseⅡ Control Group -commercialized IPV

ACTIVE COMPARATOR

* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of commercialized IPV

Biological: Three-dose regimen of commercialized IPV

Interventions

Single-dose regimen of high dosage investigational sIPVBIOLOGICAL

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

Phase I Adult Group - High dosagePhase I Child Group - High dosage
Single-dose regimen of medium dosage investigational sIPVBIOLOGICAL

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

Phase I Adult Group - Medium dosagePhase I Child Group - Medium dosage
Three-dose regimen of high dosage investigational sIPVBIOLOGICAL

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

Phase I Infant Group - High dosagePhaseⅡExperimental Group - High dosage
Three-dose regimen of medium dosage investigational sIPVBIOLOGICAL

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

Phase I Infant Group - Medium dosagePhaseⅡExperimental Group - Medium dosage
Three-dose regimen of low dosage investigational sIPVBIOLOGICAL

The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..

Phase I Infant Group - Low dosagePhaseⅡExperimental Group - Low dosage
Three-dose regimen of commercialized sIPVBIOLOGICAL

The control vaccine was manufactured by Chinese Academy of Medical Sciences.

PhaseⅡControl Group -commercialized sIPV
Three-dose regimen of commercialized IPVBIOLOGICAL

The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).

PhaseⅡ Control Group -commercialized IPV

Eligibility Criteria

Age2 Months - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
  • Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
  • Proven legal identity;
  • Participants (≥ 18 years old), or guardians of the participants (\< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
  • Complying with the requirement of the study protocol;
  • Axillary temperature ≤ 37.0 °C;

You may not qualify if:

  • Breast feeding, pregnant, or expected to conceive in the next 60 days;
  • History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
  • Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
  • Autoimmune disease or immunodeficiency/immunosuppressive;
  • serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
  • severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
  • History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
  • Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
  • Long term history of alcoholism or drug abuse;
  • Receipt of any of the following products:
  • Any subunit or inactivated vaccine within the past 7 day;
  • Any live attenuated vaccine within the past 14 days;
  • Any other investigational medicine(s) within the past 30 days;
  • Any blood product within the past 3 months;
  • Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pizhou City Center for Disease Control and Prevention

Xuzhou, Jiangsu, 221300, China

Location

Related Publications (1)

  • Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.

    PMID: 30249424DERIVED

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Study Officials

  • Yuemei Hu

    Jiangsu Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2016

First Posted

December 7, 2016

Study Start

October 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 26, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)