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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494740
• Other study ID #: SIBP-2009-1
• Status: Completed
• Phase: Phase 2
• First received: December 15, 2011
• Last updated: December 16, 2011
• Start date: December 2009
• Est. completion date: January 2010

Study information

• Verified date: October 2009
• Source: Shanghai Institute Of Biological Products
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 36 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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.
• 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.
• split-virion, non-adjuvanted vaccine of seasonal influenza
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

Locations

Country	Name	City	State
China	Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutination inhibition antibody titer		Days 35	No
Secondary	Occurrence of solicited local and systemic adverse events after vaccination		Day0-42	Yes