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Consistency Lots Vaccine Study (V260-009)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092456
First Posted: September 27, 2004
Last Update Posted: October 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: June 19, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Rotavirus Infections
Interventions: Biological: rotavirus vaccine, live, oral, pentavalent
Biological: 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

The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004

(last dose given).

Last subject completed follow-up: 13-Aug-2004.

All data corrections applied (Frozen File) date: 30-Sep-2004


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded

from the trial.


Reporting Groups
  Description
RotaTeq™ Lot 1 Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
RotaTeq™ Lot 2 Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
RotaTeq™ Lot 3 Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
Placebo Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination

Participant Flow:   Overall Study
    RotaTeq™ Lot 1   RotaTeq™ Lot 2   RotaTeq™ Lot 3   Placebo
STARTED   226 [1]   225 [2]   229 [3]   113 [4] 
Vaccinated at Visit 1   226   225   229   113 
Vaccinated at Visit 2   208   217   210   104 
Vaccinated at Visit 3   202   210   200   98 
COMPLETED   201 [5]   208 [5]   200 [5]   97 [5] 
NOT COMPLETED   25   17   29   16 
Adverse Event                0                0                1                1 
Lost to Follow-up                2                2                1                2 
Protocol Violation                5                7                8                6 
Withdrawal by Subject                13                5                16                6 
Moved                1                1                0                1 
Not Specified                4                2                3                0 
[1] Subject assigned to ~8.81 X 10^7 IU/Dose of RotaTeq™ - Lot 1
[2] Subject assigned to ~8.01 X 10^7 IU/Dose of RotaTeq™ - Lot 2
[3] Subject assigned to ~6.91 X 10^7 IU/Dose of RotaTeq™ - Lot 3
[4] Subjects assigned to Placebo-matching RotaTeq™
[5] Subjects who received 3 scheduled vaccinations; with up to 42 days safety follow-up after each dose



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
RotaTeq™ Lot 1 Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
RotaTeq™ Lot 2 Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
RotaTeq™ Lot 3 Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
Placebo Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
Total Total of all reporting groups

Baseline Measures
   RotaTeq™ Lot 1   RotaTeq™ Lot 2   RotaTeq™ Lot 3   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 226   225   229   113   793 
Age, Customized 
[Units: Participants]
         
6 to 12 Weeks   225   224   228   113   790 
Over 12 Weeks   1   1   1   0   3 
Gender 
[Units: Participants]
         
Female   118   98   108   43   367 
Male   108   127   121   70   426 
Race/Ethnicity, Customized 
[Units: Participants]
         
White   139   144   147   68   498 
Hispanic American   57   49   52   28   186 
Black   13   11   6   5   35 
Multi-Racial   10   10   16   6   42 
Other   7   11   8   6   32 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]   [ Time Frame: 42 days following the 3rd vaccination ]

2.  Other Pre-specified:   Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).   [ Time Frame: 42 days following the 3rd vaccination ]

3.  Other Pre-specified:   Number of Subjects With Clinical Adverse Experiences (CAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

4.  Other Pre-specified:   Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

5.  Other Pre-specified:   Number of Subjects With Vaccine-Related Clinical AEs (CAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

6.  Other Pre-specified:   Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

7.  Other Pre-specified:   Number of Subjects Discontinued Due to Clinical Adverse Experiences   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

8.  Other Pre-specified:   Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

9.  Other Pre-specified:   Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]

10.  Other Pre-specified:   Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)   [ Time Frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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.


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092456     History of Changes
Other Study ID Numbers: V260-009
2004_078
First Submitted: September 22, 2004
First Posted: September 27, 2004
Results First Submitted: June 19, 2009
Results First Posted: April 12, 2011
Last Update Posted: October 5, 2015