Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00362648
First received: August 8, 2006
Last updated: November 4, 2013
Last verified: November 2013
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


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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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™ - 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
  Show All Outcome Measures

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days post any vaccination. Kenya Safety Cohort subjects were followed for all nonserious and serious adverse experiences for 42 days post any vaccination.
Additional Description For SAFETY displays (SAEs and Other Adverse Events); SAE information is reported by treatment received and not reported by Region or subset. Other Adverse Events were only recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
RotaTeq™

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.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).

Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.

Placebo

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.

SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).

Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination.

RotaTeq™, Placebo, RotaTeq™

Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.

Placebo, Placebo, RotaTeq™

Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.

Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination.

RotaTeq™ - Kenya Safety Cohort A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
Placebo - Kenya Safety Cohort A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.

Other Adverse Events
    RotaTeq™     Placebo     RotaTeq™, Placebo, RotaTeq™     Placebo, Placebo, RotaTeq™     RotaTeq™ - Kenya Safety Cohort     Placebo - Kenya Safety Cohort  
Total, other (not including serious) adverse events              
# participants affected / at risk     0/0     0/0     0/0     0/0     137/149     147/152  
Blood and lymphatic system disorders              
Anaemia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     4/152 (2.63%)  
Congenital, familial and genetic disorders              
Phimosis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Ear and labyrinth disorders              
Otorrhoea † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Eye disorders              
Conjunctivitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     10/149 (6.71%)     13/152 (8.55%)  
Eye discharge † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     3/152 (1.97%)  
Eye swelling † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Gastrointestinal disorders              
Abdominal pain † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     4/149 (2.68%)     1/152 (0.66%)  
Abdominal pain upper † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     1/152 (0.66%)  
Constipation † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     5/149 (3.36%)     0/152 (0.00%)  
Diarrhoea † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     71/149 (47.65%)     67/152 (44.08%)  
Diarrhoea haemorrhagic † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     0/152 (0.00%)  
Dyspepsia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Enteritis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     2/152 (1.32%)  
Faeces hard † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Glossodynia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Vomiting † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     35/149 (23.49%)     31/152 (20.39%)  
General disorders              
Feeling hot † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     2/152 (1.32%)  
Oedema peripheral † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Pyrexia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     96/149 (64.43%)     98/152 (64.47%)  
Infections and infestations              
Abscess † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Abscess of eyelid † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Bronchiolitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     5/149 (3.36%)     2/152 (1.32%)  
Bronchitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     0/152 (0.00%)  
Bronchopneumonia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     10/149 (6.71%)     8/152 (5.26%)  
Cellulitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Dysentery † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     2/152 (1.32%)  
Fungal infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     1/152 (0.66%)  
Fungal skin infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     0/152 (0.00%)  
Gastroenteritis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     39/149 (26.17%)     45/152 (29.61%)  
Impetigo † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Laryngitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     2/152 (1.32%)  
Lower respiratory tract infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     1/152 (0.66%)  
Malaria † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     23/149 (15.44%)     34/152 (22.37%)  
Nasopharyngitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     3/149 (2.01%)     3/152 (1.97%)  
Oral candidiasis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     15/149 (10.07%)     14/152 (9.21%)  
Oropharyngeal candidiasis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Otitis externa † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Otitis media † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     3/149 (2.01%)     1/152 (0.66%)  
Pharyngitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     2/152 (1.32%)  
Pneumonia † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     16/149 (10.74%)     19/152 (12.50%)  
Respiratory tract infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     4/149 (2.68%)     4/152 (2.63%)  
Rhinitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     54/149 (36.24%)     62/152 (40.79%)  
Septic rash † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     3/149 (2.01%)     3/152 (1.97%)  
Sinusitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     2/152 (1.32%)  
Tinea capitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     4/152 (2.63%)  
Tinea infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Tinea versicolour † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Tuberculosis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Umbilical sepsis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Upper respiratory tract infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     5/149 (3.36%)     6/152 (3.95%)  
Urinary tract infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     2/152 (1.32%)  
Viral infection † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Injury, poisoning and procedural complications              
Soft tissue injury † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Tongue injury † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Metabolism and nutrition disorders              
Feeding disorder of infancy or early childhood † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     1/152 (0.66%)  
Fontanelle bulging † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Nervous system disorders              
Convulsion † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Crying † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     2/152 (1.32%)  
Reproductive system and breast disorders              
Vaginal discharge † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Respiratory, thoracic and mediastinal disorders              
Allergic cough † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     3/152 (1.97%)  
Bronchospasm † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     7/149 (4.70%)     6/152 (3.95%)  
Cough † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     89/149 (59.73%)     90/152 (59.21%)  
Dyspnoea † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     22/149 (14.77%)     23/152 (15.13%)  
Hiccups † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Nasal congestion † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     1/152 (0.66%)  
Rhinorrhoea † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     30/149 (20.13%)     18/152 (11.84%)  
Skin and subcutaneous tissue disorders              
Dermatitis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     2/149 (1.34%)     2/152 (1.32%)  
Dermatitis allergic † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     5/149 (3.36%)     8/152 (5.26%)  
Dermatitis diaper † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     2/152 (1.32%)  
Heat rash † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     3/152 (1.97%)  
Hyperhidrosis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Pemphigus † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Pityriasis † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Pruritus generalized † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Rash † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     57/149 (38.26%)     56/152 (36.84%)  
Rash generalized † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/149 (0.00%)     1/152 (0.66%)  
Urticaria † 1            
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)     1/149 (0.67%)     0/152 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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.


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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00362648     History of Changes
Other Study ID Numbers: V260-015, 2006_027
Study First Received: August 8, 2006
Results First Received: March 11, 2010
Last Updated: November 4, 2013
Health Authority: Ghana: Ministry of Health