Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine i… (NCT01021397) | Clinical Trial Compass
CompletedPhase 1
Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children
United States12 participantsStarted 2009-11
Plain-language summary
Human parainfluenza viruses (HPIVs) are a major health concern in infants and young children under 5 years of age, causing serious respiratory tract disease. The primary purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children.
Who can participate
Age range6 Months – 36 Months
SexALL
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Inclusion Criteria:
* Good general health
* HPIV3-uninfected
* Has received age-appropriate inactivated or subunit routine immunizations at least 2 weeks prior to study entry
* Has received age-appropriate live routine immunizations at least 4 weeks prior to study entry and at least 2 weeks for rotavirus and inactivated vaccines
* Available for the duration of the trial
* Parent or guardian reachable by telephone for post-immunization contact
* Parent or guardian willing to provide informed consent
Exclusion Criteria:
* Known or suspected impairment of immunologic functions. Infants who are HIV-infected, who are bone marrow or solid organ transplant recipients, or who have received immunosuppressive therapy, including systemic corticosteroids within 30 days prior to study entry. Infants who are using topical steroids, topical antibiotic ointments and topical antifungal agents are not excluded.
* Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
* Previously received HPIV3 vaccine
* Previous serious vaccine-associated adverse event or anaphylactic reaction
* Known hypersensitivity to any vaccine component
* Lung or heart disease, including reactive airway disease. Infants with clinically insignificant cardiac abnormalities are not excluded. Infants or children who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bron…
What they're measuring
1
Frequency of vaccine-related reactogenicity events and other adverse events
Timeframe: Throughout study
2
Amount of serum antibody induced by vaccine in each recipient
Timeframe: Throughout study
Trial details
NCT IDNCT01021397
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)