Efficacy, Safety, Reactogenicity & Immunogenicity of the Rotarix Vaccine in Japanese Infants

This study has been completed.

Study NCT00480324 Information provided by GlaxoSmithKline

First Received on May 29, 2007. Last Updated on October 21, 2010 History of Changes

Results First Received: March 30, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Gastroenteritis Caused by Rotavirus Rotavirus Vaccines
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
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Reporting Groups

	Description
Rotarix Group	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
Placebo Group	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

Participant Flow: Overall Study

	Rotarix Group	Placebo Group
STARTED	508	257
COMPLETED	476	241
NOT COMPLETED	32	16
Adverse Event	1	1
Protocol Violation	0	1
Withdrawal by Subject	14	5
Lost to Follow-up	17	8
Subject’s mother pregnant	0	1

Baseline Characteristics

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Reporting Groups

	Description
Rotarix Group	Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
Placebo Group	Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.

Baseline Measures

	Rotarix Group	Placebo Group	Total
Number of Participants [units: participants]	508	257	765
Age [units: weeks] Mean ± Standard Deviation	7.7 ± 1.99	7.7 ± 2.05	7.7 ± 2.01
Gender [units: participants]
Female	229	134	363
Male	279	123	402

Outcome Measures

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1. Primary:

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ]

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2. Secondary:

Number of Subjects Reporting Severe Rotavirus (RV) Gastroenteritis (GE) Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ]

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3. Secondary:

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of G1 Type [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ]

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4. Secondary:

Number of Subjects Reporting Any Rotavirus (RV) Gastroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains of Non-G1 Types [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ]

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5. Secondary:

Number of Subjects Hospitalized Due to Rotavirus (RV) Gastroenteritis (GE) Caused by the Circulating Wild-type RV Strains [ Time Frame: From 2 weeks after Dose 2 up to 2 years of age ]

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6. Secondary:

Number of Subjects Reporting Any Rotavirus (RV) Gatroenteritis (GE) and Severe RV GE Leading to Medical Intervention and Caused by the Circulating Wild-type RV Strains [ Time Frame: From Dose 1 up to 2 years of age ]

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7. Secondary:

Serum Anti-rotavirus Immunoglobulin A (IgA) Antibody Concentration [ Time Frame: 2 months after Dose 2 ]

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8. Secondary:

Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A (IgA) Antibodies [ Time Frame: 2 months after Dose 2 ]

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9. Secondary:

Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 8-day follow-up period after each dose ]

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10. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period after each dose ]

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11. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Up to 2 years 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
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Results Point of Contact:

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

Publications:

Kawamura N et al. Efficacy of human rotavirus vaccine RIX4414 in Japanese infants from 2 weeks post dose 2 up to data lock point. Abstract presented at the 28th meeting of European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.

Responsible Party:	E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00480324 History of Changes
Other Study ID Numbers:	107625
Study First Received:	May 29, 2007
Results First Received:	March 30, 2010
Last Updated:	October 21, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency