Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01666262
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 16, 2012
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University

January 11, 2010
August 16, 2012
August 16, 2012
September 2009
Not Provided
Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ]
Same as current
No Changes Posted
Humoral immune response [ Time Frame: 11/2 year ]
Peak immunogenicity blood specimen and nasal washing for accessing immune response IgA. Nasal swab on D2, D3, D5, D7 after immunization. Blood for ASC assay at D0 (baseline) and D7 after each dose of vaccine.
Same as current
Not Provided
Not Provided
Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.

Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.

Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: >12-18 years, >18-49 years and >49 years.

Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
  • Biological: Vaccine A/17/CA/2009/38 (H1N1)
    Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
    Other Name: GPO Flu Vaccine-01
  • Other: Placebo:Stabilizer
    5% sucrose
  • Experimental: A/17/CA/2009/38 (H1N1)
    Intervention: Biological: Vaccine A/17/CA/2009/38 (H1N1)
  • Placebo Comparator: Stabilizer
    Intervention: Other: Placebo:Stabilizer
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2012
Not Provided

Inclusion Criteria:

  • Healthy
  • Age 9 - >49 years old
  • Having Thai ID card or equivalent
  • Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
  • Anti HIV - Negative
  • All hematology & biochemistry within normal range
  • Able to read and write and sign written informed consent

Exclusion Criteria:

  • Known history of egg allergy
  • Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
  • History of bronchial asthma
  • History of chronic lung diseases
  • History of chronic rhinitis
  • History of immunodeficiency state
  • History of immunosuppression
  • Acute infectious and noninfectious diseases (within 2 weeks)
  • Exacerbation of chronic diseases or cancer or HIV positives
  • Anamnestic leukocytosis, hepatitis B and C positives
  • The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
  • Participation in other research study
  • Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
  • Any concomitant medication with Aspirin
Sexes Eligible for Study: All
9 Years to 65 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Punnee Pitisuttithum, Mahidol University
Mahidol University
Not Provided
Principal Investigator: Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad Mahidol University
Mahidol University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP