Developing World Study for RotaTeq™

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00362648

First received: August 8, 2006

Last updated: April 26, 2010

Last verified: April 2010

History of Changes

Results First Received: March 11, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Conditions:	Vomiting Diarrhea Fever
Interventions:	Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: 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
The study was conducted at 5 international sites – Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given). Last subject completed follow-up: 31 March 2009 All data corrections applied (Frozen File): 20 July 2009

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

The study was conducted at 5 international sites – Ghana, Kenya, Mali, Bangladesh, and Vietnam from 29 March 2007 (first patient in) to 13 October 2008 (last dose given).

Last subject completed follow-up: 31 March 2009

All data corrections applied (Frozen File): 20 July 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Excluded from the trial before assignment to groups were subjects: with history of active gastrointestinal illness (vomiting, diarrhea, elevated temperature); who were participating in (or expected to participate in) other investigational-product studies; who could not be followed adequately for safety.

Reporting Groups

	Description
RotaTeq™ - Africa	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo - Africa	Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
RotaTeq™ - Asia	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo - Asia	Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Participant Flow: Overall Study

	RotaTeq™ - Africa	Placebo - Africa	RotaTeq™ - Asia	Placebo - Asia
STARTED	2733 ^[1]	2735 ^[1]	1018 ^[1]	1018 ^[1]
Vaccinated at Visit 1	2733	2735	1018	1018
Vaccinated at Visit 2	2657	2666	1013	1009
Vaccinated at Visit 3	2613	2612	1009	1007
COMPLETED	2607 ^[2]	2601 ^[2]	1009 ^[2]	1007 ^[2]
NOT COMPLETED	126	134	9	11
Adverse Event	12	21	1	0
Lost to Follow-up	62	69	4	3
Protocol Violation	4	2	2	2
Withdrawal by Subject	48	42	2	6

[1]	Subjects who passed all entry criteria and who were randomized in to the study
[2]	Subjects vaccinated and followed up to 14 days after each dose

Baseline Characteristics

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Reporting Groups

	Description
RotaTeq™ - Africa	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo - Africa	Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
RotaTeq™ - Asia	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo - Asia	Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Total	Total of all reporting groups

Baseline Measures

	RotaTeq™ - Africa	Placebo - Africa	RotaTeq™ - Asia	Placebo - Asia	Total
Number of Participants [units: participants]	2733	2735	1018	1018	7504
Age, Customized [units: participants]
<27 Days	0	1	0	0	1
27 to 41 Days	536	569	3	7	1115
42 to 84 Days	2197	2165	1015	1011	6388
Gender [units: participants]
Female	1359	1370	464	492	3685
Male	1374	1365	554	526	3819
Race/Ethnicity, Customized [units: participants]
Black	2733	2735	0	0	5468
Asian	0	0	1017	1016	2033
Multi-Racial	0	0	1	2	3

Outcome Measures

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1. Primary:

Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose [ Time Frame: At least 14 days following the third vaccination ]

Show Outcome Measure 1

2. Secondary:

Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 14 days following the 3rd vaccination ]

Show Outcome Measure 2

3. Secondary:

Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 14 days following the 3rd vaccination ]

Hide Outcome Measure 3

Measure Type	Secondary
Measure Title	Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Measure Description	Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Time Frame	14 days following the 3rd vaccination
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.
Per Protocol Population

Reporting Groups

	Description
RotaTeq™ - Asia	Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
Placebo - Asia	Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.

Measured Values

	RotaTeq™ - Asia	Placebo - Asia
Number of Participants Analyzed [units: participants]	131	132
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [units: Subjects]
≥ 3 fold rise in anti-rotavirus IgA	115	24
≥ 3 fold rise in antibody titer: Serotype G1	42	3
≥ 3 fold rise in antibody titer: Serotype G2	13	1
≥ 3 fold rise in antibody titer: Serotype G3	37	4
≥ 3 fold rise in antibody titer: Serotype G4	24	0
≥ 3 fold rise in antibody titer: Serotype P1A[8]	36	7

Statistical Analysis 1 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	87.8
95% Confidence Interval	( 80.9 to 92.9 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Anti-rotavirus IgA
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 2 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	32.1
95% Confidence Interval	( 24.2 to 40.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G1
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	9.9
95% Confidence Interval	( 5.4 to 16.4 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G2
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 4 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	28.2
95% Confidence Interval	( 20.7 to 36.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G3
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 5 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	18.3
95% Confidence Interval	( 12.1 to 26.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G4
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 6 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	RotaTeq™ - Asia
Percentage ^[2]	27.5
95% Confidence Interval	( 20.0 to 36.0 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype P1A[8]
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 7 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	18.2
95% Confidence Interval	( 12.0 to 25.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Anti-rotavirus IgA
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 8 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	2.3
95% Confidence Interval	( 0.5 to 6.5 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G1
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 9 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	0.8
95% Confidence Interval	( 0.0 to 4.1 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G2
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 10 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	3.0
95% Confidence Interval	( 0.8 to 7.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G3
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 11 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	0.0
95% Confidence Interval	( 0.0 to 2.8 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype G4
[2]	Other relevant estimation information:
	No text entered.

Statistical Analysis 12 for Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]

Groups ^[1]	Placebo - Asia
Percentage ^[2]	5.3
95% Confidence Interval	( 2.2 to 10.6 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Serotype P1A[8]
[2]	Other relevant estimation information:
	No text entered.

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: Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372

No publications provided by Merck

Publications automatically indexed to this study:

Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schödel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. Epub 2010 Aug 6.

Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schödel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. Epub 2010 Aug 6.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00362648 History of Changes
Other Study ID Numbers:	2006_027, V260-015
Study First Received:	August 8, 2006
Results First Received:	March 11, 2010
Last Updated:	April 26, 2010
Health Authority:	Ghana: Ministry of Health

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