Consistency Lots Vaccine Study (V260-009)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092456
First received: September 22, 2004
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: June 19, 2009  
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 Infections
Interventions: Biological: rotavirus vaccine, live, oral, pentavalent
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
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
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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  
Number of Participants  
[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
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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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092456     History of Changes
Other Study ID Numbers: V260-009, 2004_078
Study First Received: September 22, 2004
Results First Received: June 19, 2009
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration