NCT01551823

Brief Summary

The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2012

Shorter than P25 for phase_3

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

March 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

March 9, 2012

Last Update Submit

October 8, 2023

Conditions

Influenza

Keywords

Influenza Virus Vaccine (Split Virion, Inactivated)Influenza

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

    six months

Study Arms (2)

Team 1

EXPERIMENTAL

Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections

Biological: Influenza Virus Vaccine(no Preservative )

Team 2

EXPERIMENTAL

Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections

Biological: Influenza Virus Vaccine(contains Preservative)

Interventions

Influenza Virus Vaccine(no Preservative )BIOLOGICAL

Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections

Team 1
Influenza Virus Vaccine(contains Preservative)BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections

Also known as: Vaxigrip
Team 2

Eligibility Criteria

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

You may qualify if:

  • Males and females, age from 6 months to 35 months ;
  • Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
  • Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
  • Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
  • Axillary temperature ≤37℃.

You may not qualify if:

  • Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
  • Low platelet or bleeding disorder do not allow vaccination into the muscle;
  • Have damaged or lower immunological function;
  • Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
  • Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
  • Have serious anaphylaxis or high fever, convulsion during first dose;
  • Have serious adverse event which related to previous vaccination;
  • Withdrawal and Discontinuance Criteria;
  • Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
  • Vaccinated with any other vaccine（except DTP）;
  • Stop observation determined by investigator owing to occurring serious adverse event.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dingxing Center for Disease Prevention and Control

Shijiazhuang, Hebei, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Guoyang Liao, Ph. D

    Institute of Medical Biology, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Yuliang Zhao, MD

    Hubei Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2012

First Posted

March 13, 2012

Study Start

March 1, 2012

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

October 11, 2023

Record last verified: 2023-10

Locations

CN(1)