Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

December 16, 2011 updated by: Shanghai Institute Of Biological Products
The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy infants aged between 6 and 35 months
  2. full-term birth with birth weight above 2,500 grams
  3. Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures

Exclusion Criteria:

  1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
  3. History of progressive or severe neurologic disorder
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
  6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
  7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  10. Guillain-Barre Syndrome
  11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
  13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
  14. Any conditions may influence the evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: split-virion, non-adjuvanted vaccine of 7.5 μg
split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.
Biological: split-virion, non-adjuvanted vaccine of 7.5 μg
120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
EXPERIMENTAL: split-virion, non-adjuvanted vaccine of 15 μg
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
PLACEBO_COMPARATOR: split-virion, non-adjuvanted vaccine of seasonal influenza
split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.
Biological: split-virion, non-adjuvanted vaccine of seasonal influenza
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemagglutination inhibition antibody titer
Time Frame: Days 35
Days 35

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of solicited local and systemic adverse events after vaccination
Time Frame: Day0-42
Day0-42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Institute Of Biological Products

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

December 15, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (ESTIMATE)

December 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIBP-2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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