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CompletedNCT01494740Updated Dec 19, 2011

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

A Phase 2 interventional study of split-virion, non-adjuvanted vaccine of 7.5 μg and split-virion, non-adjuvanted H1N1 vaccine of 15 μg in Influenza, sponsored by Shanghai Institute Of Biological Products. Completed at 1 site in China. Open to participants aged 6 Months to 36 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-12-19.

Sponsored by Shanghai Institute Of Biological Products · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
6 Months to 36 Months
Sex
All
01

Study summary

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

02

Conditions studied

  • Influenza

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Keywords

  • H1N1
  • Vaccine
  • Immunogenicity
  • Safety
  • infants
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 312 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Shanghai Institute Of Biological Products is the lead sponsor of 34 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 36 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
312 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Biologicalsplit-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.

  • Biologicalsplit-virion, non-adjuvanted H1N1 vaccine of 15 μg

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

  • Biologicalsplit-virion, non-adjuvanted vaccine of seasonal influenza

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

06

What researchers measure

Primary outcomes

  1. Hemagglutination inhibition antibody titer

    Time frame: Days 35

Secondary outcomes

  1. Occurrence of solicited local and systemic adverse events after vaccination

    Time frame: Day0-42

07

Study locations

1 site
  • Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China
    Changsha, China
08

References and documents

Publications

  • 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. PubMed 25110632 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01494740
Lead sponsor
Shanghai Institute Of Biological Products
Responsible party
Sponsor
First posted
Dec 19, 2011
Start date
Dec 2009
Primary completion
Jan 2010
Completion
Jan 2010
Last update
Dec 19, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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