Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in… (NCT01254175) | Clinical Trial Compass
CompletedPhase 1
Evaluating the Safety and Immunogenicity of a Human Parainfluenza Type 3 (HPIV3) Virus Vaccine in Infants and Children
United States28 participantsStarted 2010-12
Plain-language summary
Human parainfluenza virus type 3 (HPIV3) is a major cause of pneumonia and other respiratory diseases in infants and children. This study will evaluate the safety and immune response of an HPIV3 vaccine in infants and young children.
Who can participate
Age range6 Months – 36 Months
SexALL
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Inclusion Criteria:
* Parent/guardian(s) of participants can demonstrate their understanding of the study (by taking a multiple choice questionnaire), sign the informed consent, and agree to vaccine administration following a detailed explanation of the study
* Seronegative for HPIV3, as defined by serum antibody titer hemagglutination inhibition (HAI) less than or equal to 1:8, as determined within 30 days prior to inoculation
* Medical history has been reviewed and a physical examination indicates that participant is in good health
* In the view of the site investigator, participant has received routine immunizations appropriate for age, administered at least 2 weeks prior to study entry (inactivated and subunit vaccines and rotavirus vaccine), or at least 4 weeks prior to study entry (live vaccines except rotavirus vaccine)
* Available for the entire study period and parent/guardian can be reached by telephone for post-inoculation contacts
* For children born to HIV-infected women, the child can be considered HIV-uninfected if he/she has either two negative polymerase chain reaction (PCR) tests with one collected at greater than 1 month of age and one collected at greater than 4 months of age, or two negative antibody tests
* If there is an immunocompromised child in the household who is less than 5 years of age, his/her last CD4 count must be greater than 15%
Exclusion Criteria:
* Known or suspected impairment of immunological functions, HIV infection, or currently (wi…
What they're measuring
1
Frequency of vaccine-related reactogenicity events that occur during the acute monitoring phase of the study
Timeframe: Measured at Days 0-18 after each vaccination
2
Proportion of participants that develop 4-fold or greater rises in hemagglutination inhibition (HAI) antibody titer following 2 doses of vaccine
Timeframe: Measured through 31 days after the second vaccination
Trial details
NCT IDNCT01254175
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)