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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: split-virion, non-adjuvanted vaccine of 7.5 μg; Biological: split-virion, non-adjuvanted vaccine of seasonal influenza; Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg

• Registration Number: NCT01494740
• Lead Sponsor: Shanghai Institute Of Biological Products

Brief Summary

The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-10
• Study Start: 2009-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-16
• Last Update Submitted: 2011-12-16
• Study First Posted: 2011-12-19
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
split-virion, non-adjuvanted vaccine of 7.5 μg	split-virion, non-adjuvanted vaccine of 7.5 μg	split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.
split-virion, non-adjuvanted vaccine of seasonal influenza	split-virion, non-adjuvanted vaccine of seasonal influenza	split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.
split-virion, non-adjuvanted vaccine of 15 μg	split-virion, non-adjuvanted H1N1 vaccine of 15 μg	split-virion, non-adjuvanted H1N1 vaccine of 15 μg.

Primary Outcome Measures

Name	Time	Method
Hemagglutination inhibition antibody titer	Days 35

Secondary Outcome Measures

Name	Time	Method
Occurrence of solicited local and systemic adverse events after vaccination	Day0-42

Trial Locations

Locations (1)

Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China; 🇨🇳 Changsha, China