Safety of an aerosol attenuated measles vaccine in healthy subjects with Omron's nebuliser, Aerogen's clinical nebuliser and Trudell's nebuliser

Completed

• Conditions: Measles infection; Infections and Infestations

• Registration Number: ISRCTN03256458
• Lead Sponsor: World Health Organization (WHO) (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male subject, 18 to 35 years old for first group
2. Male or female at the age of 1 to 17 years for second and third group
3. Residence in the study area
4. Measles immune, as determined by Plaque Reduction Neutralisation (PRN) titre greater than 120 mIU/ml
5. Healthy on the day of the visit as supported by physical examination and laboratory evaluation on preset parameters
6. Signed informed consent (subject and/or parent/guardian/legal representative)
7. Expressed interest and availability to fulfil the study requirements
8. Non pregnant as certified by pregnancy test and agreement to avoid pregnancy for at least 30 days after vaccination (women of childbearing age)
9. Willing not to receive any experimental drug or vaccine within 90 days after study vaccination

Exclusion Criteria

1. Human Immunodeficiency Virus (HIV) positive (serology test)
2. Pregnant (based on positive pregnancy test)
3. Immunodeficiency or suppression (disease or iatrogenic induced), seizure disorder and progressive neurological disorder
4. Enrolled in any experimental drug or vaccine study within 30 days prior to vaccination
5. Known hypersensitivity to any component of the study vaccine
6. History of thrombocytopenia or immune thrombocytopenia purpura
7. Significant psychiatric or medical illness, including pulmonary disease (such as asthma requiring medication)
8. Severe malnutrition, as indicated by current guidelines by Indian Academic of Paediatrics
9. Axillary temperature greater than 38.3°C or other acute illness on the day of scheduled vaccination
10. Household contact who has a medical history suggestive of disease or drug induced immunodeficiency or suppression (e.g. ongoing treatment with an immunosuppressive agent, chronic diarrhoea for greater than one month, fever for greater than one month, chronic cough for greater than one month, generalised dermatitis or lymphadenopathy, gastrointestinal candidiasis)
11. Receipt of any licensed vaccine within 30 days prior to vaccination

Study & Design

• Study Type: Interventional
• Study Design: Not specified