Trials Sponsors Conditions Drugs Pricing

Conditions

H7N9 Influenza

Keywords

H7N9

Outcome Measures

Primary Outcomes (1)

Number of Subjects Reporting Solicited and Unsolicited Adverse Events (AEs)
* For each group the incidence rate of subjects with solicited AE(s) with 95% confidence interval * For each group the incidence rate of subjects with unsolicited AE(s) with 95% confidence interval
Continuous observation for 30 days after two inoculations

Secondary Outcomes (3)

Number of participants that presented seroconversion post injection
21 days after two inoculations
Number of participants that presented seroprotection post injection
21 days after two inoculations
Geometric mean of Hemagglutination-inhibition titre post first study injection
21 days after two inoculations

Study Arms (2)

15μg H7N9 Vaccine

EXPERIMENTAL

Participants will be inoculated with 2 doses of 15μg hemagglutinin antigen of H7N9 vaccine at 21-day intervals.

Biological: 15μg H7N9 Vaccine

Aluminum hydroxide adjuvant

PLACEBO COMPARATOR

Participants will be first inoculated with one dose of seasonal influenza vaccine and followed with one dose of aluminum hydroxide adjuvant at 21-day intervals.

Biological: Aluminum Hydroxide Adjuvant

Interventions

15μg H7N9 VaccineBiological

The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.

15μg H7N9 Vaccine

Aluminum Hydroxide AdjuvantBiological

The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Over the age of 12 years, healthy population
Subjects/ (and the guardian) informed consent, voluntarily participated and signed the informed consent form, with the ability to use thermometers, scales and to fill in diary cards as required

Sponsors & Collaborators

Shanghai Institute Of Biological Products
Industrylead

Study Sites (1)

Suiping Center for Disease Control and Prevention

Zhumadian, Henan, 463100, China

Study Officials

Xia Shengli, PhD
Henan Center for Disease Control and Prevention
PRINCIPAL INVESTIGATOR

Enrollment

560 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
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

November 14, 2018

First Posted

November 28, 2018

Study Start

November 10, 2018

Actual (reported)

A Study of An Adjuvanted Inactivated H7N9 Influenza Vaccine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

15μg H7N9 Vaccine

Aluminum hydroxide adjuvant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

15μg H7N9 Vaccine

Aluminum hydroxide adjuvant

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations