Completed
A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
What is being tested
Pandemic influenza A/H1N1 vaccine
+ Seasonal trivalent vaccine
Biological
Who is being recruted
Infections+4
+ Influenza, Human
+ Orthomyxoviridae Infections
From 6 to 35 Months
+22 Eligibility Criteria
How is the trial designed
Prevention Study
Placebo-ControlledPhase 4
Interventional
Study Start: December 2009
Summary
Principal SponsorSinovac Biotech Co., Ltd
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2009
Actual date on which the first participant was enrolled.A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).
Official TitleA Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants
Principal SponsorSinovac Biotech Co., Ltd
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
310 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 35 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
InfectionsInfluenza, HumanOrthomyxoviridae InfectionsRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus Diseases
Criteria
3 inclusion criteria required to participate
Healthy male or female aged between 6 and 35 months
Full-term birth, birth weight 2,500 grams or more
provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent
19 exclusion criteria prevent from participating
Cases, cured cases and close contact of influenza A (H1N1) virus
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Symptoms of acute infection within a week
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Experimental120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart
Group II
Experimental120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart
Group III
Sham60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
GuangXi Center for Diseases Control and Prevention
Guilin, ChinaOpen GuangXi Center for Diseases Control and Prevention in Google MapsCompletedOne Study Center