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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Vaccine A/17/CA/2009/38 (H1N1) Other: Placebo:Stabilizer Phase 1 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais
Study Start Date : September 2009
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: A/17/CA/2009/38 (H1N1) 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

Placebo Comparator: Stabilizer Other: Placebo:Stabilizer
5% sucrose

Primary Outcome Measures :
  1. Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ]

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   9 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01666262

Faculty of Tropical Medicine, Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Principal Investigator: Prof.Punnee Pitisuttithum, MBBS,DTM&HDipGrad Mahidol University

Responsible Party: Punnee Pitisuttithum, Professor, Mahidol University Identifier: NCT01666262     History of Changes
Other Study ID Numbers: GPO FLU VACCINE-01
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: August 16, 2012
Last Verified: August 2012

Keywords provided by Punnee Pitisuttithum, Mahidol University:

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs