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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

Rotarix (primary vaccination study)

Placebo (primary vaccination study)

About this trial

This is an interventional prevention trial for Infections, Rotavirus focused on measuring Intussusception, Gastroenteritis, Finland

Eligibility Criteria

32 Months - 3 Years (Child)All SexesAccepts Healthy Volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rotarix Group

Placebo Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Secondary Outcome Measures

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Number of Subjects With Severe Gastroenteritis (GE)

Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.

Number of Subjects Reporting Serious Adverse Events (SAEs)

An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Number of Subjects Reporting Intussusception (IS)

Intussusception is defined as the telescoping of the intestine.

Full Information

NCT ID

NCT00420316

First Posted

January 10, 2007

Last Updated

July 23, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00420316

Brief Title

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

Official Title

To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 12, 2007 (Actual)

Primary Completion Date

August 8, 2007 (Actual)

Study Completion Date

August 8, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infections, Rotavirus

Keywords

Intussusception, Gastroenteritis, Finland

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1613 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rotarix Group

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Biological

Intervention Name(s)

Rotarix (primary vaccination study)

Intervention Description

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

Intervention Type

Biological

Intervention Name(s)

Placebo (primary vaccination study)

Intervention Description

Two liquid oral doses of placebo

Primary Outcome Measure Information:

Title

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)

Description

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Secondary Outcome Measure Information:

Title

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)

Description

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype

Description

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype

Description

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

Description

Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

Description

Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects With Severe Gastroenteritis (GE)

Description

Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects Reporting Serious Adverse Events (SAEs)

Description

An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

Time Frame

During the study period for the long-term follow-up (i.e. 6 months)

Title

Number of Subjects Reporting Intussusception (IS)

Description

Intussusception is defined as the telescoping of the intestine.

Time Frame

During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

32 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Espoo

ZIP/Postal Code

02100

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

GSK Investigational Site

City

Helsinki

ZIP/Postal Code

00930

Country

Finland

Facility Name

GSK Investigational Site

City

Jarvenpaa

ZIP/Postal Code

04400

Country

Finland

Facility Name

GSK Investigational Site

City

Kotka

ZIP/Postal Code

48600

Country

Finland

Facility Name

GSK Investigational Site

City

Kuopio

ZIP/Postal Code

70100

Country

Finland

Facility Name

GSK Investigational Site

City

Lahti

ZIP/Postal Code

15140

Country

Finland

Facility Name

GSK Investigational Site

City

Oulu

ZIP/Postal Code

90100

Country

Finland

Facility Name

GSK Investigational Site

City

Pori

ZIP/Postal Code

28120

Country

Finland

Facility Name

GSK Investigational Site

City

Seinajoki

ZIP/Postal Code

60100

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33100

Country

Finland

Facility Name

GSK Investigational Site

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

GSK Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

GSK Investigational Site

City

Vantaa

ZIP/Postal Code

01300

Country

Finland

Facility Name

GSK Investigational Site

City

Vantaa

ZIP/Postal Code

01600

Country

Finland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

109810

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Infections, Rotavirus

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial