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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090233
First received: August 25, 2004
Last updated: September 18, 2015
Last verified: September 2015
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 
Overall Participants Analyzed 
[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 
[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.
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 


  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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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: September 18, 2015
Health Authority: United States: Food and Drug Administration