A Study of the Safety and Immune Response to RotaTeq™ Vaccine in the Elderly (V260-027)

This study has been terminated.

(Strategic business decision not to pursue indication due to lack of demonstrable medical need)

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00836498

First received: February 3, 2009

Last updated: February 24, 2011

Last verified: February 2011

History of Changes

Results First Received: January 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Rotavirus
Interventions:	Biological: Comparator: RotaTeq Biological: Comparator: Placebo Biological: Comparator: RotaTeq + Placebo

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of participants occurred at 8 study sites in the United States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Part II was not conducted; no participants were recruited.

Reporting Groups

	Description
RotaTeq™	Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Placebo	Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.

Participant Flow: Overall Study

	RotaTeq™	Placebo
STARTED	44	22
COMPLETED	40 ^[1]	21
NOT COMPLETED	4	1
Adverse Event	1	0
Lost to Follow-up	1	0
Withdrawal by Subject	2	1

[1]	Participant who discontinued the study vaccination due to AE completed the 180-day safety follow-up.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
RotaTeq™	Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Placebo	Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
Total	Total of all reporting groups

Baseline Measures

	RotaTeq™	Placebo	Total
Number of Participants [units: participants]	44	22	66
Age, Customized ^[1] [units: participants]	44	22	66
Gender [units: participants]
Female	23	13	36
Male	21	9	30
Region of Enrollment [units: participants]
United States	44	22	66

[1]	Between 65 and 80 years.

Outcome Measures

Show All Outcome Measures

1. Primary:

Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) [ Time Frame: Up to 42 days following any dose of RotaTeq™ or placebo ]

Show Outcome Measure 1

2. Primary:

Part I: Number of Participants With Serious Adverse Experiences (SAEs) [ Time Frame: Up to 180 days following the third dose of RotaTeq™ or placebo ]

Show Outcome Measure 2

3. Primary:

Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 3

4. Primary:

Part II: Number of Participants With Nonserious Adverse Experiences [ Time Frame: Up to 42 days following any dose of RotaTeq™ and/or placebo ]

Show Outcome Measure 4

5. Primary:

Part II: Number of Participants With Serious Adverse Experiences [ Time Frame: Up to 180 days following the third dose of RotaTeq™ and/or placebo ]

Show Outcome Measure 5

6. Primary:

Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 ]

Show Outcome Measure 6

7. Secondary:

Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 7

8. Secondary:

Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 8

9. Secondary:

Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 9

10. Secondary:

Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 10

11. Secondary:

Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo ]

Show Outcome Measure 11

12. Secondary:

Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 ]

Show Outcome Measure 12

13. Secondary:

Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A [ Time Frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 ]

Show Outcome Measure 13

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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.

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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00836498 History of Changes
Other Study ID Numbers:	V260-027, 2007_537
Study First Received:	February 3, 2009
Results First Received:	January 12, 2011
Last Updated:	February 24, 2011
Health Authority:	United States: Food and Drug Administration

To Top