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

NCT01494740 | Completed Phase 2 DMC

• 1 other identifier: SIBP-2009-1
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

H1N1; Vaccine; Immunogenicity; Safety; infants

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibition antibody titer

  Days 35

Secondary Outcomes (1)

• Occurrence of solicited local and systemic adverse events after vaccination

  Day0-42

Study Arms (3)

split-virion, non-adjuvanted vaccine of 7.5 μg

EXPERIMENTAL

split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.

Biological: split-virion, non-adjuvanted vaccine of 7.5 μg

split-virion, non-adjuvanted vaccine of 15 μg

EXPERIMENTAL

split-virion, non-adjuvanted H1N1 vaccine of 15 μg.

Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg

split-virion, non-adjuvanted vaccine of seasonal influenza

PLACEBO COMPARATOR

split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.

Biological: split-virion, non-adjuvanted vaccine of seasonal influenza

Interventions

split-virion, non-adjuvanted vaccine of 7.5 μg BIOLOGICAL

120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.

split-virion, non-adjuvanted vaccine of 7.5 μg

split-virion, non-adjuvanted H1N1 vaccine of 15 μg BIOLOGICAL

120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

split-virion, non-adjuvanted vaccine of 15 μg

split-virion, non-adjuvanted vaccine of seasonal influenza BIOLOGICAL

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

split-virion, non-adjuvanted vaccine of seasonal influenza

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
• Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
• History of progressive or severe neurologic disorder
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• 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
• 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
• 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
• History of thyroidectomy or thyroid disease that required medication within the past 12 months
• Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
• Guillain-Barre Syndrome
• Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
• Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
• Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
• Any conditions may influence the evaluation

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

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

Changsha, China

Location

Related Publications (1)

• Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014.

  PMID: 25110632 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: December 19, 2011
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 19, 2011

Record last verified: 2009-10

Locations

CN (1)