Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions:	Prophylaxis Rotavirus Gastroenteritis Caused by Rotavirus
Interventions:	Biological: Placebo Biological: Rotarix™

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the total of 4941 subjects enrolled in this study, 2 subjects were allocated a subject number but did not get any study vaccine administered. Hence, only 4939 subjects were considered as 'started'.

Reporting Groups

	Description
Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Placebo Group	Subjects received 3 doses of placebo.

Participant Flow: Overall Study

	Rotarix 2-dose Group	Rotarix 3-dose Group	Placebo Group
STARTED	1647	1651	1641
COMPLETED	1420	1383	1392
NOT COMPLETED	227	268	249
Adverse Event	46	45	45
Protocol Violation	3	5	4
Withdrawal by Subject	59	74	81
Lost to Follow-up	116	142	116
Non-compliance	2	1	2
Return dates not reliable	1	0	0
Vaccinated at regular clinic	0	0	1
Subject's parent passed away	0	1	0

Baseline Characteristics

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Reporting Groups

	Description
Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Placebo Group	Subjects received 3 doses of placebo.

Baseline Measures

	Rotarix 2-dose Group	Rotarix 3-dose Group	Placebo Group	Total
Number of Participants [units: participants]	1647	1651	1641	4939
Age [units: weeks] Mean ± Standard Deviation	6.3 ± 0.92	6.4 ± 0.98	6.4 ± 0.97	6.4 ± 0.95
Gender [units: subjects]
Female	811	839	800	2450
Male	836	812	841	2489

Outcome Measures

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1. Primary:

Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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2. Secondary:

Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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3. Secondary:

Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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4. Secondary:

Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From the first vaccine or placebo dose up to 1 year of age ]

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5. Secondary:

In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the third dose of vaccine or placebo up to 1 year of age ]

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6. Secondary:

Number of Subjects Reporting Severe Gastroenteritis of Any Cause [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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7. Secondary:

Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out [ From the first dose of vaccine or placebo up to 1 year of age ]

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Measure Type	Secondary
Measure Title	Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out
Measure Description	An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Time Frame	From the first dose of vaccine or placebo up to 1 year of age
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Rotarix 2-dose Group	Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group	Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Rotarix Pooled Group	For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
Placebo Group	Subjects received 3 doses of placebo.

Measured Values

	Rotarix 2-dose Group	Rotarix 3-dose Group	Rotarix Pooled Group	Placebo Group
Number of Participants Analyzed [units: participants]	1647	1651	3298	1641
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out [units: subjects]	46	45	91	44

No statistical analysis provided for Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out

8. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ From the first dose of vaccine or placebo up to 1 year of age ]

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9. Secondary:

Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects [ One month after the last vaccine dose ]

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10. Secondary:

Number of Seroconverted Subjects [ One month after the last vaccine or placebo dose ]

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11. Secondary:

Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies [ One month after the last vaccine or placebo dose ]

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12. Secondary:

Number of Seropositive Subjects [ One month after the last vaccine or placebo dose ]

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13. Secondary:

Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	102248, 111274
Study First Received:	October 18, 2005
Results First Received:	June 18, 2009
Last Updated:	August 13, 2009
ClinicalTrials.gov Identifier:	NCT00241644 History of Changes
Health Authority:	South Africa: Medicines Control Council