NCT04363359

Brief Summary

To evaluate the immunogenicity and safety of 2 doses of quadrivalent influenza virus split vaccine in healthy population aged 6-35 month., so as to provide a data support for phase III clinical trials.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,980

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2020

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

January 15, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2021

Completed
Last Updated

December 26, 2023

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

April 17, 2020

Last Update Submit

December 21, 2023

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

  • seroconversion rate of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroconversion rate of HI antibodies against any subtype of influenza virus in each group.

    56 days

  • seroprotection rate of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, seroprotection rate of HI antibodies against any subtype of influenza virus in each group.

    56 days

  • GMT and GMI of HI antibodies

    28 days after receiving two doses of vaccine in subjects aged 6-35 months, GMT and GMI of HI antibodies against any subtype of influenza virus in each group.

    56 days

Secondary Outcomes (1)

  • Reactogenicity Events

    30 days and 6 months

Study Arms (4)

Quadrivalent influenza vaccine HD

EXPERIMENTAL

Participants randomized to receive two injections of 0.5 mL quadrivalent influenza vaccine at Day 0 and 28.

Biological: 0.5ml Quadrivalent influenza vaccine

Quadrivalent influenza vaccine LD

EXPERIMENTAL

Participants randomized to receive two injections of 0.25 mL quadrivalent influenza vaccine at Day 0 and 28.

Biological: 0.25ml Quadrivalent influenza vaccine

Trivalent influenza vaccine Victoria

ACTIVE COMPARATOR

Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Victoria strain at Day 0 and 28.

Biological: 0.25ml Trivalent influenza vaccine(B/V)

Trivalent influenza vaccine Yamagata

ACTIVE COMPARATOR

Participants randomized to receive two injections of 0.25 mL trivalent influenza vaccine containing B/Yamagata strain at Day 0 and 28.

Biological: 0.25ml Trivalent influenza vaccine(B/Y)

Interventions

0.5ml Quadrivalent influenza vaccineBIOLOGICAL

The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

Quadrivalent influenza vaccine HD
0.25ml Quadrivalent influenza vaccineBIOLOGICAL

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains

Quadrivalent influenza vaccine LD
0.25ml Trivalent influenza vaccine(B/V)BIOLOGICAL

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains

Trivalent influenza vaccine Victoria
0.25ml Trivalent influenza vaccine(B/Y)BIOLOGICAL

The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains

Trivalent influenza vaccine Yamagata

Eligibility Criteria

Age6 Months - 35 Months
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy infants aged 6-35 months.
  • Volunteer legal guardian or client informed consent, voluntarily participate in and sign informed consent.
  • The volunteer legal guardian or client has the ability (non-illiterate) to understand the study procedures, to use a thermometer, scale, and fill in a diary card as required, and be able to complete the clinical study in compliance with the clinical trial protocol.

You may not qualify if:

  • The underarm body temperature on the day of enrollment was \> 37.0℃.
  • Have been suffering from influenza within the previous 3 months (confirmed by either clinical, serological or microbiological methods).
  • Any previous influenza vaccination (registered or experimental) within 6 months or any planned influenza vaccination during the study period.
  • Allergic to any component of the vaccine, a history of allergic reactions to eggs or gentamicin sulfate.
  • A history of severe allergy to any vaccine or drug.
  • Preterm birth (delivered before 37 weeks of gestation), low birth weight baby (birth weight \< 2300g for girls, \<2500g for boys).
  • Dystocia, asphyxia rescue, nervous system damage history;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Acute illness, severe chronic illness or acute attack of chronic disease on the day of vaccination;
  • A history of live attenuated vaccination within 14 days prior to vaccination and a history of other vaccinations within 7 days prior to vaccination;
  • Patients who received immunoenhancement or inhibitor therapy within 3 months (continued oral or intravenous administration for more than 14 days);
  • Congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
  • History of asthma, past two years of instability requiring emergency treatment, hospitalization, intubation, oral or intravenous administration of corticosteroids;
  • Have received blood or blood-related products;
  • A history of convulsion, epilepsy, encephalopathy, guillain-barre syndrome, a history of mental illness or a family history;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henan Provincial Center for Disease Control and Prevention

Shangqiu, Henan, 450016, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Shilei Wang, PhD

    Shanghai Institute Of Biological Products

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 27, 2020

Study Start

January 15, 2020

Primary Completion

September 14, 2021

Study Completion

September 14, 2021

Last Updated

December 26, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)