Long-term Efficacy and Safety of Subjects Approximately 3... | NCT00420316

NCT00420316

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rotarix Group	Experimental	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.	Biological: Rotarix (primary vaccination study)
Placebo Group	Placebo Comparator	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.	Biological: Placebo (primary vaccination study)

Name	Type	Description	Arm Group Labels	Other Names
Rotarix (primary vaccination study)	Biological	GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.	Rotarix Group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Espoo		02100	Finland
GSK Investigational Site

References Module

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

ID	Type	URL	Comment
109810	Individual Participant Data Set	View IPD

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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No data is available for this block.

Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Months

Title

Denominators

Categories

Title	Measurements
	OG0004 OG0013

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Vaccine efficacy with respect to any rotavirus gastroenteritis (RV GE) caused by the circulating wild-type rotavirus strain. Vaccine efficacy (VE) was defined as the percent reduction in the frequency of the relevant outcome variable in vaccinated subjects compared with those subjects who received placebo.	Fisher Exact		0.691		Percent reduction	34.3			2-Sided	95	-348.7	88.9					Superiority or Other

Secondary

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.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

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.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Secondary

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.

The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Subjects Reporting Intussusception (IS)

Intussusception is defined as the telescoping of the intestine.

The analysis was performed on the Total Cohort, which included all subjects who participated in this follow up study with at least one vaccine administration documented in the primary study.

Posted

Number

Subjects

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

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.			4	1,082	0	1,082
EG001	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.			7	531	0	531

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,082 at risk EG0011 affected531 at risk
Febrile convulsion	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,082 at risk EG0011 affected531 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,082 at risk EG0011 affected531 at risk
Pneumonia	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,082 at risk EG0012 affected531 at risk
Laryngitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,082 at risk EG0010 affected531 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,082 at risk EG0011 affected531 at risk
Tonsillitis	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,082 at risk EG0010 affected531 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,082 at risk EG0011 affected531 at risk

ID	Term
D012400	Rotavirus Infections
D007443	Intussusception
D005759	Gastroenteritis

Ancestor Terms

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections
D007415	Intestinal Obstruction
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
C492457	RIX4414 vaccine

Units	Counts
Participants	OG0001082 OG001531