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A Clinical Trial With Influenza A/H1N1 Vaccines

NCT00956111 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1614

Last updated 2021-07-29

No results posted yet for this study

Summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Conditions

Interventions

BIOLOGICAL

split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.

BIOLOGICAL

split-virion, adjuvanted H1N1 vaccine of 15 μg per dose

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart.

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.

BIOLOGICAL

split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.

BIOLOGICAL

whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose

100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart.

BIOLOGICAL

whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose

100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine

BIOLOGICAL

placebo control

100 adults were assigned to receive 2 doses of placebo 21 days apart.

Sponsors & Collaborators

  • Sinovac Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-09-30
Completion
2009-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956111 on ClinicalTrials.gov