Phase IIIb, Double Blind, Randomised, Placebo-Controlled, Multi-Country/Centre, Study to Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Pre-Term Infants

GlaxoSmithKline

Description

This study is planned to evaluate the safety (in terms of occurrence of any serious adverse events), reactogenicity (any side effects) and immunogenicity (ability of the vaccine to develop antibodies that fight infection) of the HRV vaccine when used in pre-term infants aged between 6 and 14 weeks at the time of the first dose in Portugal, France and Poland and in pre-term infants aged between 6 and 12 weeks at the time of first dose in Spain. The study will be performed in four European countries (France, Poland, Spain, and Portugal). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Citations (0)

Mentions (0)

Metrics

Dataset Index

0.2

FAIR Score

31%

Citations

0

Mentions

0

Metrics Over Time

Publication Details

DOI

Publisher

Vivli

License

Study data may be accessed by completing a request form at https://vivli.org. It will then be reviewed according to the data contributor’s governance policy, see https://vivli.org/members/ourmembers/ for Vivli member’s review process. If approved, use of the data is governed by the data use agreement at https://vivli.org/resources/vivli-data-use-agreement/

Assigned Domain

Subfield

Pharmacology

Field

Medicine

Domain

Health Sciences

Confidence Score

45%

Source

Scholar Data Model

Keywords

Conditions: Infections, RotavirusInterventions: Rotarix™Interventions: Placebo

Normalization Factors

FT

44.23

CTw

1.00

MTw

1.00