A Study to Explore the Existence of Horizontal Transmission of the RIX4414 Vaccine Strain Between Twins Within a Family

This study has been completed.

Study NCT00396630 Information provided by GlaxoSmithKline

First Received on November 6, 2006. Last Updated on April 1, 2009 History of Changes

Results First Received: February 13, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Pharmacokinetics/Dynamics Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Rotavirus Gastroenteritis
Interventions:	Biological: Rotarix Biological: Placebo

Participant Flow

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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
Within each pair of twins enrolled in the study, one subject was assigned to the Rotarix Group and one to the Placebo Group.

Reporting Groups

	Description
Rotarix Group	All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
Placebo Group	All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Description

Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Participant Flow: Overall Study

	Rotarix Group	Placebo Group
STARTED	100	100
COMPLETED	95 ^[1]	95 ^[1]
NOT COMPLETED	5	5
Lost to Follow-up	1	1
Withdrawal by Subject	1	1
Not vaccinated at Visit 3	3	3

[1]	Completed Visit 4 (Week 17).

Baseline Characteristics

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Reporting Groups

	Description
Rotarix Group	All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).
Placebo Group	All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2). Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Description

Rotarix Group

All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Placebo Group

All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).

Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3).

Baseline Measures

	Rotarix Group	Placebo Group	Total
Number of Participants [units: participants]	100	100	200
Age [units: Weeks] Mean ± Standard Deviation	8.2 ± 1.80	8.2 ± 1.80	8.2 ± 1.80
Gender [units: participants]
Female	56	49	105
Male	44	51	95

Outcome Measures

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1. Primary:

Presence of Rotavirus Vaccine Strain in Any Stool Sample From Twin Receiving Placebo. [ Time Frame: On the day of each vaccine/placebo dose, then three times weekly for 6 consecutive weeks starting after each vaccine/placebo dose and on the day of Visit 3. ]

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2. Secondary:

Duration of Human Rotavirus (HRV) Shedding Per Study Group. [ Time Frame: From Day 0 up to Week 13 ]

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3. Secondary:

Anti-rotavirus Immunoglobulin A (IgA) Antibody Seroconversion. [ Time Frame: At Visit 3 (Week 13). ]

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4. Secondary:

Anti-rotavirus IgA Antibody Concentration. [ Time Frame: At Visit 3 (Week 13). ]

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5. Secondary:

Number of Subjects With Gastroenteritis (GE) and Rotavirus Gastroenteritis (RV GE) Episodes. [ Time Frame: Until Visit 4 (Week 17) for GE and until Visit 3 (Week 13) for RV GE. ]

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6. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs). [ Time Frame: Within 31 days after any doses. ]

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7. Secondary:

Number of Subjects Reporting Any Serious Adverse Events (SAEs). [ Time Frame: Up to Visit 4. ]

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8. Secondary:

Analysis by Sequencing of Genomic Mutations in the HRV Vaccine Strain After Transmission. [ Time Frame: During the entire study period. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

9. Secondary:

Live Viral Vaccine Load in the Stool of the Twin Receiving Placebo in Case of Transmission. [ Time Frame: During the entire study period. ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

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 by GlaxoSmithKline

Publications automatically indexed to this study:

Rivera L, Peña LM, Stainier I, Gillard P, Cheuvart B, Smolenov I, Ortega-Barria E, Han HH. Horizontal transmission of a human rotavirus vaccine strain--a randomized, placebo-controlled study in twins. Vaccine. 2011 Nov 28;29(51):9508-13. Epub 2011 Oct 18.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00396630 History of Changes
Other Study ID Numbers:	106260
Study First Received:	November 6, 2006
Results First Received:	February 13, 2009
Last Updated:	April 1, 2009
Health Authority:	Dominican Republic: Secretaria de Estado de Salud Pública y Asistencia Social (SESPAS) United States: Food and Drug Administration