Home | All trials

[RDF data]
Trial NCT00000829

Resource URI: http://static.linkedct.org/resource/trials/NCT00000829
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/20236>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/8650>
linkedct:brief_title A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/4606>
linkedct:condition <http://static.linkedct.org/resource/condition/10205>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Antipyretics for rectal temperature >= 100.4 F. - Antiretroviral therapy. Patients must have: - HIV positivity. - Birth weight at least 1800 g (3.75 lb). - Consent and compliance of parent or guardian. NOTE: - Coenrollment in other therapeutic protocols (except ACTG 218, 230, and 279) is permitted. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Enrollment in HIV vaccine trials. - Major congenital anomalies that are incapacitating, result in immunologic abnormalities, or require major surgical procedures. - Congenital immunoglobulin deficiency, SS or SC hemoglobinopathy, or asplenia. - Hypogammaglobulinemia. Concurrent Medication: Excluded: - Prophylactic antipyretics. Patients with the following prior conditions are excluded: Acute moderate to severe intercurrent illness or fever within 72 hours prior to study entry. Prior Medication: Excluded: - Any prior pneumococcal vaccine. - Measles vaccine within 1 month prior to study vaccination. - Any other routine vaccine within 1 week prior to study vaccination. - Any immunosuppressant agent, including prednisone, for more than 6 weeks. Prior Treatment: Excluded: - Blood products within 56 days prior to study vaccination.
linkedct:description Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein. Infants are randomized to receive either heptavalent pneumococcal conjugate vaccine or placebo by intramuscular injection at study months 0, 2, and 4, and then at 15 months of age. Additionally, patients receive PNU-IMUNE 23 ( pneumococcal polyvalent vaccine ) at 24 months of age.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 6 Months
linkedct:eligibility_minimum_age 2 Months
linkedct:enrollment 60 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000829
linkedct:intervention <http://static.linkedct.org/resource/intervention/105062>
linkedct:intervention <http://static.linkedct.org/resource/intervention/107045>
linkedct:intervention <http://static.linkedct.org/resource/intervention/107067>
rdfs:label Trial NCT00000829
linkedct:lastchanged_date September 25, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/105306>
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/151107>
linkedct:location <http://static.linkedct.org/resource/location/151122>
linkedct:location <http://static.linkedct.org/resource/location/152674>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153259>
linkedct:location <http://static.linkedct.org/resource/location/153763>
linkedct:location <http://static.linkedct.org/resource/location/153882>
linkedct:location <http://static.linkedct.org/resource/location/153995>
linkedct:location <http://static.linkedct.org/resource/location/154169>
linkedct:location <http://static.linkedct.org/resource/location/154391>
linkedct:location <http://static.linkedct.org/resource/location/154945>
linkedct:location <http://static.linkedct.org/resource/location/155582>
linkedct:location <http://static.linkedct.org/resource/location/155960>
linkedct:location <http://static.linkedct.org/resource/location/156523>
linkedct:location <http://static.linkedct.org/resource/location/157412>
linkedct:location <http://static.linkedct.org/resource/location/160320>
linkedct:location <http://static.linkedct.org/resource/location/162802>
linkedct:location <http://static.linkedct.org/resource/location/163743>
linkedct:location <http://static.linkedct.org/resource/location/167197>
linkedct:location <http://static.linkedct.org/resource/location/170081>
linkedct:location <http://static.linkedct.org/resource/location/171716>
linkedct:location <http://static.linkedct.org/resource/location/174045>
linkedct:location <http://static.linkedct.org/resource/location/181624>
linkedct:location <http://static.linkedct.org/resource/location/186734>
linkedct:location <http://static.linkedct.org/resource/location/192654>
linkedct:location <http://static.linkedct.org/resource/location/192981>
linkedct:location <http://static.linkedct.org/resource/location/193168>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/202102>
linkedct:location <http://static.linkedct.org/resource/location/210066>
linkedct:location <http://static.linkedct.org/resource/location/213279>
linkedct:location <http://static.linkedct.org/resource/location/216005>
linkedct:location <http://static.linkedct.org/resource/location/216582>
linkedct:location <http://static.linkedct.org/resource/location/217340>
linkedct:location <http://static.linkedct.org/resource/location/220112>
linkedct:nct_id NCT00000829
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Double-Blind Placebo-Controlled Trial of the Safety and Immunogenicity of a Seven Valent Pneumococcal Conjugate Vaccine in Presumed HIV-Infected Infants
linkedct:org_study_id ACTG 292
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/25141>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/53980>
linkedct:overall_status Active, not recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/2920>
foaf:page <http://clinicaltrials.gov/show/NCT00000829>
linkedct:phase Phase 1
linkedct:primary_completion_date June 2005
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/74980>
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/74983>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/120627>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/29557>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/29832>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/67256>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:start_date November 1999
linkedct:study_design Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
linkedct:study_type Interventional
linkedct:summary To assess whether HIV-infected infants who receive a heptavalent pneumococcal conjugate vaccine have more local reactions at the site of injection and systemic reactions than placebo subjects. To assess whether this vaccine is more immunogenic than placebo following the third vaccination. Children with HIV infection are at increased risk for invasive pneumococcal infection, particularly bacteremia. A large proportion of pneumococcal disease is caused by a limited number of serotypes. The maximum number of pneumococcal serotypes that can be included in a new conjugate vaccine is felt to be limited by the amount of carrier protein. A heptavalent pneumococcal conjugate vaccine has been developed that consists of pneumococcal capsular saccharides from serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F bound to a diphtheria toxin mutant carrier protein.
rdf:type linkedct:trials
linkedct:verification_date August 2004