passages: 3062
passages: document
passages: Safety and preliminary immunogenicity of Cuban pneumococcal conjugate vaccine candidate in healthy children : a randomized phase I clinical trial . A new heptavalent conjugate vaccine ( PCV7-TT ) is under development in Cuba . PCV7-TT contains 2 μg of serotypes 1 , 5 , 14 , 18C , 19F , 23F and 4 μg of 6B , each one conjugated to tetanus toxoid ( TT ) . This vaccine was designed with the serotypes that cause most invasive pneumococcal diseases ( IPD ) worldwide . In the present study , we investigated the safety and explored the immunogenicity of PCV7-TT during a controlled , randomized and double blind clinical trial phase I in 4-5-year-old children . PCV7-TT was well tolerated and as safe as Synflorix used as control vaccine . Following a single-dose vaccination , all individual serotypes included in PCV7-TT induced statistically significant increase of IgG GMC and OPA GMT . These are the first clinical results of PCV7-TT in children and they pave the way toward next clinical trials in children and infants . This clinical trial was published in the Cuban Public Register of Clinical Trials with code RPCEC00000173 .
entities: 3063
entities: Intervention_Pharmacological
entities: Cuban pneumococcal conjugate vaccine
entities: 3064
entities: Intervention_Pharmacological
entities: heptavalent conjugate vaccine ( PCV7-TT )
entities: 3065
entities: Intervention_Pharmacological
entities: PCV7-TT
entities: 3066
entities: Intervention_Pharmacological
entities: PCV7-TT
entities: 3067
entities: Intervention_Pharmacological
entities: PCV7-TT
entities: 3068
entities: Intervention_Control
entities: Synflorix
entities: 3069
entities: Intervention_Pharmacological
entities: PCV7-TT
entities: 3070
entities: Intervention_Pharmacological
entities: PCV7-TT
entities: 3071
entities: Outcome_Other
entities: Safety
entities: 3072
entities: Outcome_Physical
entities: preliminary immunogenicity
entities: 3073
entities: Outcome_Other
entities: safety
entities: 3074
entities: Outcome_Physical
entities: immunogenicity
entities: 3075
entities: Outcome_Physical
entities: IgG GMC
entities: 3076
entities: Outcome_Physical
entities: OPA GMT
entities: 3077
entities: Participant_Condition
entities: healthy children
entities: 3078
entities: Participant_Age
entities: 4-5-year-old children