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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Punnee Pitisuttithum, Mahidol University
ClinicalTrials.gov Identifier:
NCT01666262
First received: January 11, 2010
Last updated: August 10, 2012
Last verified: August 2012

January 11, 2010
August 10, 2012
September 2009
Not Provided
Systemic reaction and local reaction (vital sign, temperature) [ Time Frame: 11/2 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01666262 on ClinicalTrials.gov Archive Site
Humoral immune response [ Time Frame: 11/2 year ] [ Designated as safety issue: No ]

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Healthy
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
363
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
Both
9 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01666262
GPO FLU VACCINE-01
Yes
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