Rotavirus Efficacy and Safety Trial (REST)(V260-006)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090233
First received: August 25, 2004
Last updated: April 6, 2011
Last verified: April 2011
Results First Received: June 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Rotavirus Infections
Interventions: Biological: Rotateq™
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
Participants were recruited at 356 sites in Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Puerto Rico, Sweden, Taiwan, and the United States from 12 Jan 2001 first patient in (FPI) to 06 Oct 2004 last patient in (LPI).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive were excluded from the trial before assignment to groups.

Reporting Groups
  Description
RotaTeq™ Three oral doses (~6.5x10^7 to ~1.2x10^8 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.

Participant Flow:   Overall Study
    RotaTeq™     Placebo  
STARTED     34644 [1]   34630 [2]
Vaccinated at Visit 1     34035 [3]   34003 [4]
Vaccinated at Visit 2     31052     31066  
Vaccinated at Visit 3     29667     29598  
COMPLETED     29645 [5]   29565 [5]
NOT COMPLETED     4999     5065  
Randomized Not Vaccinated (Visit 1)                 609                 627  
Adverse Event                 214                 198  
Lost to Follow-up                 68                 95  
Protocol Violation                 960                 1022  
Withdrawal by Subject                 182                 211  
Moved                 203                 189  
Not Specified                 1211                 1160  
Data not available at data cut-off point                 1552                 1563  
[1] Evaluated by data safety monitoring board (DSMB) when they recommended stopping enrollment
[2] Evaluated by data safety monitoring board when they recommended stopping enrollment
[3] Randomized Not vaccinated 609
[4] Randomized Not vaccinated 627
[5] Does not include participants who discontinued prior to the 42 day safety follow-up



  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™ Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Total Total of all reporting groups

Baseline Measures
    RotaTeq™     Placebo     Total  
Number of Participants  
[units: participants]
  34644     34630     69274  
Age, Customized [1]
[units: Participants]
     
5 Weeks of Age and Under     1     4     5  
6 to 12 Weeks of Age     34551     34527     69078  
Over 12 Weeks of Age     92     99     191  
Gender  
[units: participants]
     
Female     17058     17101     34159  
Male     17586     17529     35115  
Race/Ethnicity  
[units: participants]
     
White     23772     23788     47560  
Hispanic American     4963     4911     9874  
Black     2908     2941     5849  
Multi Racial     1815     1817     3632  
Asian     536     552     1088  
Native American     531     514     1045  
Other     119     107     226  
[1] The eligibility for this study was to enroll infants 6-12 weeks of age; however infants that were 5 weeks and under, and infants who were 12 weeks and over were inadvertently enrolled outside these ranges. Those infants who received at least 1 dose of study vaccine, were followed for safety.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo   [ Time Frame: Within 42 days following any dose of RotaTeq™/placebo ]

2.  Primary:   Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination   [ Time Frame: At least 14 days following the 3rd vaccination through the first full rotavirus season ]

3.  Secondary:   G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus   [ Time Frame: 14 days following the 3rd vaccination ]

4.  Secondary:   Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4   [ Time Frame: At least 14 days following the 3rd vaccination ]

5.  Secondary:   Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.   [ Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season ]

6.  Secondary:   Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose   [ Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season ]

7.  Secondary:   Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo   [ Time Frame: 42 days following third dose ]

8.  Secondary:   Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin   [ Time Frame: 42 days following third dose ]

9.  Secondary:   Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F   [ Time Frame: 42 days following third dose ]


  Serious Adverse Events
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Time Frame Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination
Additional Description Participants listed in SAE tables (34904–RotaTeq; 34862-Placebo) are those who received study treatment. Other AEs were reported for a pre-defined subset who received ≥1 dose (4808-RotaTeq; 4796–Placebo). Although a participant may have had ≥ 2 AEs they are counted only once in a category. The same participant may appear in different categories.

Reporting Groups
  Description
RotaTeq™

Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.

Placebo

Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.


Serious Adverse Events
    RotaTeq™     Placebo  
Total, serious adverse events      
# participants affected / at risk     863/34904 (2.47%)     955/34862 (2.74%)  
Blood and lymphatic system disorders      
Anaemia † 1    
# participants affected / at risk     7/34904 (0.02%)     3/34862 (0.01%)  
Idiopathic thrombocytopenic purpura † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Lymphadenitis † 1    
# participants affected / at risk     2/34904 (0.01%)     4/34862 (0.01%)  
Lymphadenopathy † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Neutropenia † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Thrombocytopenia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Cardiac disorders      
Bradycardia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Cardiac failure congestive † 1    
# participants affected / at risk     2/34904 (0.01%)     1/34862 (0.00%)  
Cardio-respiratory arrest † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Cardiopulmonary failure † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cyanosis † 1    
# participants affected / at risk     3/34904 (0.01%)     1/34862 (0.00%)  
Congenital, familial and genetic disorders      
Atrial septal defect † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Cerebral palsy † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Coarctation of the aorta † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Congenital cystic kidney disease † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Congenital intestinal malformation † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Cryptorchism † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cystic fibrosis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Developmental glaucoma † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Glycogen storage disease type ib † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hip dysplasia † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Hydrocele † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Kidney malformation † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Polycystic liver disease † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pulmonary artery stenosis congenital † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Pyloric stenosis † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Retinoblastoma † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Ventricular septal defect † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Eye disorders      
Chalazion † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Conjunctivitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Gastrointestinal disorders      
Abdominal distension † 1    
# participants affected / at risk     2/34904 (0.01%)     3/34862 (0.01%)  
Abdominal pain † 1    
# participants affected / at risk     5/34904 (0.01%)     3/34862 (0.01%)  
Anal fissure † 1    
# participants affected / at risk     3/34904 (0.01%)     1/34862 (0.00%)  
Anal fistula † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Anal haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Anal skin tags † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Aphthous stomatitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cheilitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Colitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Constipation † 1    
# participants affected / at risk     7/34904 (0.02%)     6/34862 (0.02%)  
Diarrhoea † 1    
# participants affected / at risk     9/34904 (0.03%)     21/34862 (0.06%)  
Diarrhoea haemorrhagic † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Duodenitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Dysphagia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Enteritis † 1    
# participants affected / at risk     2/34904 (0.01%)     4/34862 (0.01%)  
Faecaloma † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Flatulence † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Gastric ulcer † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Gastritis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Gastrointestinal inflammation † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Gastrointestinal pain † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Gastrooesophageal reflux disease † 1    
# participants affected / at risk     29/34904 (0.08%)     17/34862 (0.05%)  
Haematemesis † 1    
# participants affected / at risk     3/34904 (0.01%)     0/34862 (0.00%)  
Haematochezia † 1    
# participants affected / at risk     1/34904 (0.00%)     3/34862 (0.01%)  
Infantile colic † 1    
# participants affected / at risk     2/34904 (0.01%)     2/34862 (0.01%)  
Inguinal hernia † 1    
# participants affected / at risk     11/34904 (0.03%)     8/34862 (0.02%)  
Inguinal hernia, obstructive † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Intussusception † 1    
# participants affected / at risk     13/34904 (0.04%)     22/34862 (0.06%)  
Nausea † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Oesophageal obstruction † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Oesophagitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Rectal prolapse † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Reflux oesophagitis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Regurgitation of food † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Retching † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Stomatitis † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Umbilical hernia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Varices oesophageal † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Volvulus of bowel † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Vomiting † 1    
# participants affected / at risk     23/34904 (0.07%)     20/34862 (0.06%)  
General disorders      
Brain death † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Chills † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cyst † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Death † 1    
# participants affected / at risk     1/34904 (0.00%)     4/34862 (0.01%)  
Drowning † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Fever neonatal † 1    
# participants affected / at risk     2/34904 (0.01%)     1/34862 (0.00%)  
Hernia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Injection site inflammation † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Irritability † 1    
# participants affected / at risk     9/34904 (0.03%)     4/34862 (0.01%)  
Near sudden infant death syndrome † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Oedema peripheral † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Pyrexia † 1    
# participants affected / at risk     43/34904 (0.12%)     49/34862 (0.14%)  
Sudden death † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Sudden infant death syndrome † 1    
# participants affected / at risk     7/34904 (0.02%)     9/34862 (0.03%)  
Hepatobiliary disorders      
Hepatic steatosis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hepatomegaly † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Immune system disorders      
Anaphylactic reaction † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Food allergy † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hypersensitivity † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Milk allergy † 1    
# participants affected / at risk     4/34904 (0.01%)     1/34862 (0.00%)  
Infections and infestations      
Abscess † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Abscess neck † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Acute tonsillitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Adenovirus infection † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Amoebic dysentery † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Anal abscess † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Arthritis bacterial † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Bacteraemia † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Botulism † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Bronchiolitis † 1    
# participants affected / at risk     215/34904 (0.62%)     253/34862 (0.73%)  
Bronchitis † 1    
# participants affected / at risk     25/34904 (0.07%)     20/34862 (0.06%)  
Bronchitis acute † 1    
# participants affected / at risk     3/34904 (0.01%)     3/34862 (0.01%)  
Bronchitis acute viral † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Bronchitis chronic † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Bronchitis viral † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Bronchopneumonia † 1    
# participants affected / at risk     11/34904 (0.03%)     6/34862 (0.02%)  
Campylobacter intestinal infection † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Catheter site infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cellulitis † 1    
# participants affected / at risk     1/34904 (0.00%)     6/34862 (0.02%)  
Cellulitis staphylococcal † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Chest wall abscess † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Clostridium colitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Coxsackie viral infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Croup infectious † 1    
# participants affected / at risk     8/34904 (0.02%)     5/34862 (0.01%)  
Cystitis † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Dysentery † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Ear infection † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Eczema infected † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Enterocolitis infectious † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Enterovirus infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Escherichia sepsis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Escherichia urinary tract infection † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Exanthema subitum † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Febrile infection † 1    
# participants affected / at risk     2/34904 (0.01%)     3/34862 (0.01%)  
Gastroenteritis † 1    
# participants affected / at risk     73/34904 (0.21%)     127/34862 (0.36%)  
Gastroenteritis adenovirus † 1    
# participants affected / at risk     4/34904 (0.01%)     1/34862 (0.00%)  
Gastroenteritis rotavirus † 1    
# participants affected / at risk     3/34904 (0.01%)     18/34862 (0.05%)  
Gastroenteritis salmonella † 1    
# participants affected / at risk     2/34904 (0.01%)     4/34862 (0.01%)  
Gastroenteritis viral † 1    
# participants affected / at risk     8/34904 (0.02%)     6/34862 (0.02%)  
Gastrointestinal infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Groin abscess † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Haemophilus sepsis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Herpes simplex † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Impetigo † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Influenza † 1    
# participants affected / at risk     5/34904 (0.01%)     6/34862 (0.02%)  
Kawasaki's disease † 1    
# participants affected / at risk     5/34904 (0.01%)     0/34862 (0.00%)  
Laryngitis † 1    
# participants affected / at risk     12/34904 (0.03%)     6/34862 (0.02%)  
Laryngotracheitis † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Laryngotracheo bronchitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Lobar pneumonia † 1    
# participants affected / at risk     7/34904 (0.02%)     4/34862 (0.01%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     0/34904 (0.00%)     3/34862 (0.01%)  
Meningitis † 1    
# participants affected / at risk     4/34904 (0.01%)     2/34862 (0.01%)  
Meningitis aseptic † 1    
# participants affected / at risk     2/34904 (0.01%)     2/34862 (0.01%)  
Meningitis bacterial † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Meningitis enteroviral † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Meningitis haemophilus † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Meningitis streptococcal † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Meningitis viral † 1    
# participants affected / at risk     3/34904 (0.01%)     4/34862 (0.01%)  
Nasopharyngitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Oral candidiasis † 1    
# participants affected / at risk     4/34904 (0.01%)     1/34862 (0.00%)  
Otitis externa † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Otitis media † 1    
# participants affected / at risk     28/34904 (0.08%)     24/34862 (0.07%)  
Otitis media acute † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Parainfluenzae virus infection † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Parotitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Perianal abscess † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Perineal abscess † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Periorbital cellulitis † 1    
# participants affected / at risk     2/34904 (0.01%)     2/34862 (0.01%)  
Pertussis † 1    
# participants affected / at risk     6/34904 (0.02%)     7/34862 (0.02%)  
Pharyngitis † 1    
# participants affected / at risk     2/34904 (0.01%)     3/34862 (0.01%)  
Pneumococcal bacteraemia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Pneumococcal infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pneumococcal sepsis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pneumocystis jiroveci pneumonia † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pneumonia † 1    
# participants affected / at risk     55/34904 (0.16%)     58/34862 (0.17%)  
Pneumonia bacterial † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pneumonia primary atypical † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Pneumonia respiratory syncytial viral † 1    
# participants affected / at risk     5/34904 (0.01%)     2/34862 (0.01%)  
Pneumonia viral † 1    
# participants affected / at risk     1/34904 (0.00%)     3/34862 (0.01%)  
Pseudocroup † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Pyelocystitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Pyelonephritis † 1    
# participants affected / at risk     22/34904 (0.06%)     27/34862 (0.08%)  
Pyelonephritis acute † 1    
# participants affected / at risk     16/34904 (0.05%)     12/34862 (0.03%)  
Respiratory syncytial virus infection † 1    
# participants affected / at risk     10/34904 (0.03%)     6/34862 (0.02%)  
Respiratory tract infection † 1    
# participants affected / at risk     13/34904 (0.04%)     14/34862 (0.04%)  
Respiratory tract infection viral † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Rhinitis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Roseola † 1    
# participants affected / at risk     2/34904 (0.01%)     1/34862 (0.00%)  
Salmonellosis † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Scrotal infection † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Sepsis † 1    
# participants affected / at risk     7/34904 (0.02%)     4/34862 (0.01%)  
Septic shock † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Sinusitis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Skin infection † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Staphylococcal sepsis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Subcutaneous abscess † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Tonsillitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Tonsillitis streptococcal † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Tuberculosis † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Tuberculosis of peripheral lymph nodes † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     27/34904 (0.08%)     15/34862 (0.04%)  
Urinary tract infection † 1    
# participants affected / at risk     38/34904 (0.11%)     29/34862 (0.08%)  
Urosepsis † 1    
# participants affected / at risk     0/34904 (0.00%)     6/34862 (0.02%)  
Varicella † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Viral infection † 1    
# participants affected / at risk     14/34904 (0.04%)     17/34862 (0.05%)  
Viral pharyngitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Viral rash † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Viral upper respiratory tract infection † 1    
# participants affected / at risk     2/34904 (0.01%)     4/34862 (0.01%)  
Injury, poisoning and procedural complications      
Accidental overdose † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Burns second degree † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Concussion † 1    
# participants affected / at risk     3/34904 (0.01%)     6/34862 (0.02%)  
Contusion † 1    
# participants affected / at risk     2/34904 (0.01%)     1/34862 (0.00%)  
Extradural haematoma † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Fall † 1    
# participants affected / at risk     3/34904 (0.01%)     5/34862 (0.01%)  
Femur fracture † 1    
# participants affected / at risk     1/34904 (0.00%)     5/34862 (0.01%)  
Fractured skull depressed † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Head injury † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Heat exhaustion † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Humerus fracture † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Injury asphyxiation † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Limb injury † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Multiple fractures † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Overdose † 1    
# participants affected / at risk     3/34904 (0.01%)     2/34862 (0.01%)  
Post procedural haematoma † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Road traffic accident † 1    
# participants affected / at risk     4/34904 (0.01%)     2/34862 (0.01%)  
Skull fracture † 1    
# participants affected / at risk     7/34904 (0.02%)     7/34862 (0.02%)  
Subdural haematoma † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Subdural haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Thermal burn † 1    
# participants affected / at risk     1/34904 (0.00%)     4/34862 (0.01%)  
Tibia fracture † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Upper limb fracture † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Investigations      
Body temperature increased † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Occult blood positive † 1    
# participants affected / at risk     6/34904 (0.02%)     3/34862 (0.01%)  
Transaminases increased † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Weight decreased † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Metabolism and nutrition disorders      
Acidosis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Anorexia † 1    
# participants affected / at risk     3/34904 (0.01%)     4/34862 (0.01%)  
Cow's milk intolerance † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Decreased appetite † 1    
# participants affected / at risk     3/34904 (0.01%)     1/34862 (0.00%)  
Dehydration † 1    
# participants affected / at risk     19/34904 (0.05%)     23/34862 (0.07%)  
Diet refusal † 1    
# participants affected / at risk     5/34904 (0.01%)     4/34862 (0.01%)  
Failure to thrive † 1    
# participants affected / at risk     2/34904 (0.01%)     4/34862 (0.01%)  
Feeding disorder † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Feeding disorder neonatal † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Food intolerance † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Hyperinsulinaemia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hypernatraemia † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Hyponatraemia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Lactose intolerance † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Metabolic acidosis † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Weight gain poor † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Musculoskeletal and connective tissue disorders      
Chondromalacia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Growth retardation † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Brain neoplasm † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Haemangioma † 1    
# participants affected / at risk     4/34904 (0.01%)     2/34862 (0.01%)  
Neoplasm malignant † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Neuroblastoma † 1    
# participants affected / at risk     0/34904 (0.00%)     3/34862 (0.01%)  
Pineal parenchymal neoplasm malignant † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Nervous system disorders      
Anoxic encephalopathy † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Brain oedema † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Cerebral haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Convulsion † 1    
# participants affected / at risk     17/34904 (0.05%)     9/34862 (0.03%)  
Depressed level of consciousness † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Encephalopathy † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Epilepsy † 1    
# participants affected / at risk     4/34904 (0.01%)     2/34862 (0.01%)  
Febrile convulsion † 1    
# participants affected / at risk     6/34904 (0.02%)     4/34862 (0.01%)  
Hemiplegia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hydrocephalus † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Hypotonia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Hypoxic encephalopathy † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Infantile spasms † 1    
# participants affected / at risk     1/34904 (0.00%)     3/34862 (0.01%)  
Intraneural cyst † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Lethargy † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Loss of consciousness † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Myoclonus † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Nystagmus † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Somnolence † 1    
# participants affected / at risk     0/34904 (0.00%)     3/34862 (0.01%)  
Spinal cord haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Status epilepticus † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Subarachnoid haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Syncope † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Syncope vasovagal † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Thalamus haemorrhage † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Tremor † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Vocal cord paralysis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Psychiatric disorders      
Agitation † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Apathy † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Breath holding † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Crying † 1    
# participants affected / at risk     5/34904 (0.01%)     5/34862 (0.01%)  
Eating disorder † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Restlessness † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Sleep disorder † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Staring † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Renal and urinary disorders      
Hydronephrosis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Vesicoureteric reflux † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Reproductive system and breast disorders      
Balanitis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Epididymitis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Phimosis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Testicular torsion † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory distress syndrome † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Apnoea † 1    
# participants affected / at risk     7/34904 (0.02%)     5/34862 (0.01%)  
Apnoeic attack † 1    
# participants affected / at risk     2/34904 (0.01%)     3/34862 (0.01%)  
Aspiration † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Asthma † 1    
# participants affected / at risk     10/34904 (0.03%)     11/34862 (0.03%)  
Atelectasis † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Bronchial hyperactivity † 1    
# participants affected / at risk     7/34904 (0.02%)     5/34862 (0.01%)  
Bronchospasm † 1    
# participants affected / at risk     3/34904 (0.01%)     0/34862 (0.00%)  
Choking † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Chronic respiratory disease † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Cough † 1    
# participants affected / at risk     3/34904 (0.01%)     3/34862 (0.01%)  
Dyspnoea † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Hypoxia † 1    
# participants affected / at risk     5/34904 (0.01%)     5/34862 (0.01%)  
Interstitial lung disease † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Laryngospasm † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Nasal congestion † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Neonatal apnoeic attack † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Neonatal respiratory distress syndrome † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Obstructive airways disorder † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Pulmonary congestion † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pulmonary haemorrhage † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Respiratory acidosis † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Respiratory disorder † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Respiratory distress † 1    
# participants affected / at risk     7/34904 (0.02%)     7/34862 (0.02%)  
Respiratory failure † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Rhinitis allergic † 1    
# participants affected / at risk     1/34904 (0.00%)     2/34862 (0.01%)  
Sleep apnoea syndrome † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Status asthmaticus † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Tachypnoea † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Tracheomalacia † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Skin and subcutaneous tissue disorders      
Dermatitis † 1    
# participants affected / at risk     2/34904 (0.01%)     0/34862 (0.00%)  
Dermatitis allergic † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Dermatitis atopic † 1    
# participants affected / at risk     4/34904 (0.01%)     5/34862 (0.01%)  
Eczema † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Eczema infantile † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Lichen sclerosus † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Psoriasis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Purpura † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Rash † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Seborrhoea † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Urticaria † 1    
# participants affected / at risk     2/34904 (0.01%)     2/34862 (0.01%)  
Urticaria pigmentosa † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Social circumstances      
Child abuse † 1    
# participants affected / at risk     1/34904 (0.00%)     1/34862 (0.00%)  
Child neglect † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Overfeeding of infant † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Vascular disorders      
Circulatory collapse † 1    
# participants affected / at risk     1/34904 (0.00%)     0/34862 (0.00%)  
Haematoma † 1    
# participants affected / at risk     0/34904 (0.00%)     2/34862 (0.01%)  
Haemorrhage † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Pallor † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Vasculitis † 1    
# participants affected / at risk     0/34904 (0.00%)     1/34862 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (8.1)




  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
70,301 participants randomized, 69,274 evaluated, when DSMB first recommended ending enrollment.


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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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00090233     History of Changes
Other Study ID Numbers: V260-006, 2004_012
Study First Received: August 25, 2004
Results First Received: June 29, 2009
Last Updated: April 6, 2011
Health Authority: United States: Food and Drug Administration