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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: October 8, 2015
Last verified: October 2015
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
  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 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 
Overall Participants Analyzed 
[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 (91.95%)   147/152 (96.71%) 
Blood and lymphatic system disorders             
Anaemia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   4/152 (2.63%) 
Congenital, familial and genetic disorders             
Phimosis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Ear and labyrinth disorders             
Otorrhoea † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Eye disorders             
Conjunctivitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   10/149 (6.71%)   13/152 (8.55%) 
Eye discharge † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   3/152 (1.97%) 
Eye swelling † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Gastrointestinal disorders             
Abdominal pain † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   4/149 (2.68%)   1/152 (0.66%) 
Abdominal pain upper † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   1/152 (0.66%) 
Constipation † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   5/149 (3.36%)   0/152 (0.00%) 
Diarrhoea † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   71/149 (47.65%)   67/152 (44.08%) 
Diarrhoea haemorrhagic † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   0/152 (0.00%) 
Dyspepsia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Enteritis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   2/152 (1.32%) 
Faeces hard † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Glossodynia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Vomiting † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   35/149 (23.49%)   31/152 (20.39%) 
General disorders             
Feeling hot † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   2/152 (1.32%) 
Oedema peripheral † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Pyrexia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   96/149 (64.43%)   98/152 (64.47%) 
Infections and infestations             
Abscess † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Abscess of eyelid † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Bronchiolitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   5/149 (3.36%)   2/152 (1.32%) 
Bronchitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   0/152 (0.00%) 
Bronchopneumonia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   10/149 (6.71%)   8/152 (5.26%) 
Cellulitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Dysentery † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   2/152 (1.32%) 
Fungal infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   1/152 (0.66%) 
Fungal skin infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   0/152 (0.00%) 
Gastroenteritis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   39/149 (26.17%)   45/152 (29.61%) 
Impetigo † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Laryngitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   2/152 (1.32%) 
Lower respiratory tract infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   1/152 (0.66%) 
Malaria † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   23/149 (15.44%)   34/152 (22.37%) 
Nasopharyngitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   3/149 (2.01%)   3/152 (1.97%) 
Oral candidiasis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   15/149 (10.07%)   14/152 (9.21%) 
Oropharyngeal candidiasis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Otitis externa † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Otitis media † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   3/149 (2.01%)   1/152 (0.66%) 
Pharyngitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   2/152 (1.32%) 
Pneumonia † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   16/149 (10.74%)   19/152 (12.50%) 
Respiratory tract infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   4/149 (2.68%)   4/152 (2.63%) 
Rhinitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   54/149 (36.24%)   62/152 (40.79%) 
Septic rash † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   3/149 (2.01%)   3/152 (1.97%) 
Sinusitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   2/152 (1.32%) 
Tinea capitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   4/152 (2.63%) 
Tinea infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Tinea versicolour † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Tuberculosis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Umbilical sepsis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Upper respiratory tract infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   5/149 (3.36%)   6/152 (3.95%) 
Urinary tract infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   2/152 (1.32%) 
Viral infection † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Injury, poisoning and procedural complications             
Soft tissue injury † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Tongue injury † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   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   0/0   0/0   0/0   1/149 (0.67%)   1/152 (0.66%) 
Fontanelle bulging † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Nervous system disorders             
Convulsion † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Crying † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   2/152 (1.32%) 
Reproductive system and breast disorders             
Vaginal discharge † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Allergic cough † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   3/152 (1.97%) 
Bronchospasm † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   7/149 (4.70%)   6/152 (3.95%) 
Cough † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   89/149 (59.73%)   90/152 (59.21%) 
Dyspnoea † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   22/149 (14.77%)   23/152 (15.13%) 
Hiccups † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Nasal congestion † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   1/152 (0.66%) 
Rhinorrhoea † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   30/149 (20.13%)   18/152 (11.84%) 
Skin and subcutaneous tissue disorders             
Dermatitis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   2/149 (1.34%)   2/152 (1.32%) 
Dermatitis allergic † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   5/149 (3.36%)   8/152 (5.26%) 
Dermatitis diaper † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   2/152 (1.32%) 
Heat rash † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   3/152 (1.97%) 
Hyperhidrosis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Pemphigus † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Pityriasis † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Pruritus generalized † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Rash † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   57/149 (38.26%)   56/152 (36.84%) 
Rash generalized † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   0/149 (0.00%)   1/152 (0.66%) 
Urticaria † 1             
# participants affected / at risk   0/0   0/0   0/0   0/0   1/149 (0.67%)   0/152 (0.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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
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