Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) [clinicaltrials:NCT01480258]

Bio2RDF uri

Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008) [clinicaltrials:NCT01480258]

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

http://bio2rdf.org/clinicaltrials:NCT01480258

Bio2RDF identifier

NCT01480258

http://www.w3.org/2001/XMLSchema#string

Bio2RDF namespace

clinicaltrials

http://www.w3.org/2001/XMLSchema#string

Bio2RDF uri

http://bio2rdf.org/clinicaltrials:NCT01480258

http://www.w3.org/2001/XMLSchema#string

identifiers.org URI

NCT01480258

actual enrollment [clinicaltrials_vocabulary:actual-enrollment]

1.315

http://www.w3.org/2001/XMLSchema#integer

arm group [clinicaltrials_vocabulary:arm-group]

NCT01480258 arm group 2b31a017bb4b83f715f3387ea7f085d1 [clinicaltrials_resource:NCT01480258/arm-group/2b31a017bb4b83f715f3387ea7f085d1]

NCT01480258 arm group ddc30b3f49348ac330781f07568c71d8 [clinicaltrials_resource:NCT01480258/arm-group/ddc30b3f49348ac330781f07568c71d8]

authority [clinicaltrials_vocabulary:authority]

clinicaltrials_resource:1f4519c359a0eb81921eaa47b114391a

brief summary [clinicaltrials_vocabulary:brief-summary]

This study will determi ...... censed vaccine control.

http://www.w3.org/2001/XMLSchema#string

brief title [clinicaltrials_vocabulary:brief-title]

Safety, Tolerability, and Immu ...... and 11 to 12 Months (V419-008)

http://www.w3.org/2001/XMLSchema#string

clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:2ff0284da6f42f0e4f2570a7cdd03979]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:369b08ef6f2db3984c0cb1d043686614]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:6c7f0ce55e68c6c2efd173e54e0ff651]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:928e07d5ff18f906127cfca9f40d3914]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:9d2592ca97f47009bfb0b354efb36022]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:cd447c84129278a20c9f59229b1120ce]

clinicaltrials_vocabulary:secondary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:secondary-outcome]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:2fd3ff57be28bddbe7d32dc9ea59a420]

Number of responders to polyribosylribitol phosphate (PRP) antigen Post-dose 3 (12 to 13 Months) [clinicaltrials_resource:b4510138dc4f084c33bc57253ed2108a]

collaborator [clinicaltrials_vocabulary:collaborator]

Sanofi Pasteur MSD [clinicaltrials_resource:39bb1dd2158d7d827c1596e512a03d82]

completion date [clinicaltrials_vocabulary:completion-date]

2013-10-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

download date [clinicaltrials_vocabulary:download-date]

ClinicalTrials.gov processed this data on August 10, 2015

http://www.w3.org/2001/XMLSchema#string

eligibility [clinicaltrials_vocabulary:eligibility]

eligibility for clinicaltrials:NCT01480258 [clinicaltrials_resource:d893eb315360bcebb04ad5b642c63d45]

firstreceived date [clinicaltrials_vocabulary:firstreceived-date]

2011-11-23T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

has expanded access [clinicaltrials_vocabulary:has-expanded-access]

http://www.w3.org/2001/XMLSchema#string

intervention [clinicaltrials_vocabulary:intervention]

INFANRIX hexa [clinicaltrials_resource:97b3ad6beee27a1b3786be1e35fae0f3]

Rotavirus vaccine [clinicaltrials_resource:9bb9332a6605f0cd8264f28b7d58c614]

Prevenar 13 [clinicaltrials_resource:cf9bac273e29fe9776eb0f23ca41dc33]

V419 [clinicaltrials_resource:d4a4e62c8c67e688db1b5d4e2a5dd890]

is fda regulated [clinicaltrials_vocabulary:is-fda-regulated]

http://www.w3.org/2001/XMLSchema#string

keyword [clinicaltrials_vocabulary:keyword]

Haemophilus influenzae b

http://www.w3.org/2001/XMLSchema#string

Hep B

http://www.w3.org/2001/XMLSchema#string

Hib

http://www.w3.org/2001/XMLSchema#string

combination vaccine

http://www.w3.org/2001/XMLSchema#string

diphtheria

http://www.w3.org/2001/XMLSchema#string

hepatitis B

http://www.w3.org/2001/XMLSchema#string

pertussis

http://www.w3.org/2001/XMLSchema#string

polio

http://www.w3.org/2001/XMLSchema#string

poliovirus

http://www.w3.org/2001/XMLSchema#string

tetanus

http://www.w3.org/2001/XMLSchema#string

lastchanged date [clinicaltrials_vocabulary:lastchanged-date]

2013-10-14T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

lead sponsor [clinicaltrials_vocabulary:lead-sponsor]

Sanofi Pasteur MSD [clinicaltrials_resource:39bb1dd2158d7d827c1596e512a03d82]

location [clinicaltrials_vocabulary:location]

SPMSD Investigational Site 0080019 [clinicaltrials_resource:27209ca4ff2e38a4d1ca3d5515302e74]

nct id [clinicaltrials_vocabulary:nct-id]

NCT01480258

http://www.w3.org/2001/XMLSchema#string

number of arms [clinicaltrials_vocabulary:number-of-arms]

http://www.w3.org/2001/XMLSchema#integer

official title [clinicaltrials_vocabulary:official-title]

A Phase III Randomized, Double ...... n at 2, 4, and 11 to 12 Months

http://www.w3.org/2001/XMLSchema#string

org study id [clinicaltrials_vocabulary:org-study-id]

V419-008

http://www.w3.org/2001/XMLSchema#string

overall status [clinicaltrials_vocabulary:overall-status]

Completed [clinicaltrials_resource:07ca5050e697392c9ed47e6453f1453f]

oversight [clinicaltrials_vocabulary:oversight]

Italy: Ethics Committee [clinicaltrials_resource:db2021ab881d827c9d1cd97d45171617]

phase [clinicaltrials_vocabulary:phase]

Phase 3 [clinicaltrials_resource:8357418e2694434468870b487644532d]

primary completion date [clinicaltrials_vocabulary:primary-completion-date]

2013-10-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

responsible party [clinicaltrials_vocabulary:responsible-party]

[clinicaltrials_resource:dbd41868ee618d3e64daa1adf8c3a8a0]

secondary id [clinicaltrials_vocabulary:secondary-id]

2010-021491-28

http://www.w3.org/2001/XMLSchema#string

source [clinicaltrials_vocabulary:source]

Sanofi Pasteur MSD [clinicaltrials_resource:39bb1dd2158d7d827c1596e512a03d82]

start date [clinicaltrials_vocabulary:start-date]

2011-11-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

study design [clinicaltrials_vocabulary:study-design]

clinicaltrials:NCT01480258 study design [clinicaltrials_resource:b8b141916a824f4500ac954276a738e6]

study type [clinicaltrials_vocabulary:study-type]

Interventional [clinicaltrials_resource:843ac00ae5d0b7c7defb84fb42c2ce31]

url [clinicaltrials_vocabulary:url]

NCT01480258

verification date [clinicaltrials_vocabulary:verification-date]

2013-10-01T00:00:00Z

http://www.w3.org/2001/XMLSchema#dateTime

identifier

clinicaltrials:NCT01480258

http://www.w3.org/2001/XMLSchema#string

title

Safety, Tolerability, and Immu ...... and 11 to 12 Months (V419-008)

@en

inDataset

clinicaltrials_resource:bio2rdf.dataset.clinicaltrials.R3

type

Clinical Study [clinicaltrials_vocabulary:Clinical-Study]

clinicaltrials resource [clinicaltrials_vocabulary:Resource]

label

Safety, Tolerability, and Immu ...... ) [clinicaltrials:NCT01480258]

@en