Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1613 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-12

Study Completion Date

2007-08-08

Brief Summary

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To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.

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Detailed Description

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Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Rotarix Group

Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

Group Type EXPERIMENTAL

Rotarix (primary vaccination study)

Intervention Type BIOLOGICAL

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

Placebo Group

Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study.

Group Type PLACEBO_COMPARATOR

Placebo (primary vaccination study)

Intervention Type BIOLOGICAL

Two liquid oral doses of placebo

Interventions

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Rotarix (primary vaccination study)

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

Intervention Type BIOLOGICAL

Placebo (primary vaccination study)

Two liquid oral doses of placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
* Written informed consent obtained from the parent or guardian of the subject.

Minimum Eligible Age

32 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Espoo, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Järvenpää, , Finland

Site Status

GSK Investigational Site

Kotka, , Finland

Site Status

GSK Investigational Site

Kuopio, , Finland

Site Status

GSK Investigational Site

Lahti, , Finland

Site Status

GSK Investigational Site

Oulu, , Finland

Site Status

GSK Investigational Site

Pori, , Finland

Site Status

GSK Investigational Site

Seinäjoki, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

Site Status

Countries

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Finland

Study Documents

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