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Study Results
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Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
This study has been completed.
Study NCT00241644   Information provided by GlaxoSmithKline
First Received: October 18, 2005   Last Updated: August 13, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Conditions: Prophylaxis Rotavirus
Gastroenteritis Caused by Rotavirus
Interventions: Biological: Placebo
Biological: Rotarix™

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the total of 4941 subjects enrolled in this study, 2 subjects were allocated a subject number but did not get any study vaccine administered. Hence, only 4939 subjects were considered as 'started'.

Reporting Groups
  Description
Rotarix 2-dose Group Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Placebo Group Subjects received 3 doses of placebo.

Participant Flow:   Overall Study
  Rotarix 2-dose Group Rotarix 3-dose Group Placebo Group
STARTED   1647     1651     1641  
COMPLETED   1420     1383     1392  
NOT COMPLETED   227     268     249  
      Adverse Event               46                 45                 45  
      Protocol Violation               3                 5                 4  
      Withdrawal by Subject               59                 74                 81  
      Lost to Follow-up               116                 142                 116  
      Non-compliance               2                 1                 2  
      Return dates not reliable               1                 0                 0  
      Vaccinated at regular clinic               0                 0                 1  
      Subject's parent passed away               0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Rotarix 2-dose Group Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Placebo Group Subjects received 3 doses of placebo.

Baseline Measures
  Rotarix 2-dose Group Rotarix 3-dose Group Placebo Group Total
Number of Participants  
[units: participants]
 		1647 1651 1641 4939
Age  
[units: weeks]
Mean ± Standard Deviation 		6.3 ± 0.92 6.4 ± 0.98 6.4 ± 0.97 6.4 ± 0.95
Gender  
[units: subjects]
 		       
Female 811 839 800 2450
Male 836 812 841 2489



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain   [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain, Classified by Rotavirus Type   [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects Reporting Any Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain   [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain   [ From the first vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 4

5.  Secondary:   In South Africa, Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strain   [ From 2 weeks after the third dose of vaccine or placebo up to 1 year of age ]
  Show Outcome Measure 5

6.  Secondary:   Number of Subjects Reporting Severe Gastroenteritis of Any Cause   [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out   [ From the first dose of vaccine or placebo up to 1 year of age ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ From the first dose of vaccine or placebo up to 1 year of age ]
  Show Outcome Measure 8

9.  Secondary:   Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies in Initially Seronegative Subjects   [ One month after the last vaccine dose ]
  Show Outcome Measure 9

10.  Secondary:   Number of Seroconverted Subjects   [ One month after the last vaccine or placebo dose ]
  Show Outcome Measure 10

11.  Secondary:   Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies   [ One month after the last vaccine or placebo dose ]
  Show Outcome Measure 11

12.  Secondary:   Number of Seropositive Subjects   [ One month after the last vaccine or placebo dose ]
  Show Outcome Measure 12

13.  Secondary:   Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strain   [ From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]
  Show Outcome Measure 13


  Serious Adverse Events
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Reporting Groups
  Description
Rotarix 2-dose Group Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
Rotarix 3-dose Group Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
Rotarix Pooled Group For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
Placebo Group Subjects received 3 doses of placebo.

Serious Adverse Events
  Rotarix 2-dose Group Rotarix 3-dose Group Rotarix Pooled Group Placebo Group
Total, serious adverse events        
# participants affected 170   149   319   189  
Blood and lymphatic system disorders        
Anemia   *
      # participants affected / at risk
2/1647 (0.12%)  
4/1651 (0.24%)  
6/3298 (0.18%)  
2/1641 (0.12%)  
Lymphadenitis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Pancytopenia   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Haemorrhagic disorder   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Cardiac disorders        
Cardiac failure congestive   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Hypovolaemic shock   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Tachycardia   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Congenital, familial and genetic disorders        
Heart disease congenital   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Patent ductus arteriosus   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Eye disorders        
Blindness   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Gastrointestinal disorders        
Gastrointestinal disorder   *
      # participants affected / at risk
2/1647 (0.12%)  
2/1651 (0.12%)  
4/3298 (0.12%)  
2/1641 (0.12%)  
Ileus paralytic   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Inguinal hernia   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Ileus   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Intussusception   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Abdominal distension   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Intestinal obstruction   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Vomiting   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
General disorders        
Death   *
      # participants affected / at risk
2/1647 (0.12%)  
2/1651 (0.12%)  
4/3298 (0.12%)  
0/1641 (0.00%)  
Pyrexia   *
      # participants affected / at risk
0/1647 (0.00%)  
2/1651 (0.12%)  
2/3298 (0.06%)  
2/1641 (0.12%)  
Sudden infant death syndrome   *
      # participants affected / at risk
0/1647 (0.00%)  
2/1651 (0.12%)  
2/3298 (0.06%)  
2/1641 (0.12%)  
Cyst   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Irritability   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Sudden death   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Immune system disorders        
Immunosuppression   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Infections and infestations        
Gastroenteritis   *
      # participants affected / at risk
76/1647 (4.61%)  
49/1651 (2.97%)  
125/3298 (3.79%)  
79/1641 (4.81%)  
Pneumonia   *
      # participants affected / at risk
40/1647 (2.43%)  
36/1651 (2.18%)  
76/3298 (2.30%)  
46/1641 (2.80%)  
Bronchopneumonia   *
      # participants affected / at risk
25/1647 (1.52%)  
21/1651 (1.27%)  
46/3298 (1.39%)  
23/1641 (1.40%)  
Sepsis   *
      # participants affected / at risk
25/1647 (1.52%)  
22/1651 (1.33%)  
47/3298 (1.43%)  
19/1641 (1.16%)  
Bronchiolitis   *
      # participants affected / at risk
18/1647 (1.09%)  
15/1651 (0.91%)  
33/3298 (1.00%)  
16/1641 (0.98%)  
Malaria   *
      # participants affected / at risk
12/1647 (0.73%)  
9/1651 (0.55%)  
21/3298 (0.64%)  
19/1641 (1.16%)  
Upper respiratory tract infection   *
      # participants affected / at risk
6/1647 (0.36%)  
6/1651 (0.36%)  
12/3298 (0.36%)  
1/1641 (0.06%)  
Meningitis   *
      # participants affected / at risk
7/1647 (0.43%)  
3/1651 (0.18%)  
10/3298 (0.30%)  
2/1641 (0.12%)  
Pneumocystis jiroveci pneumonia   *
      # participants affected / at risk
4/1647 (0.24%)  
4/1651 (0.24%)  
8/3298 (0.24%)  
4/1641 (0.24%)  
Pulmonary tuberculosis   *
      # participants affected / at risk
3/1647 (0.18%)  
3/1651 (0.18%)  
6/3298 (0.18%)  
2/1641 (0.12%)  
Lower respiratory tract infection   *
      # participants affected / at risk
0/1647 (0.00%)  
2/1651 (0.12%)  
2/3298 (0.06%)  
3/1641 (0.18%)  
Oral candidiasis   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
3/1641 (0.18%)  
Bronchitis   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
2/1641 (0.12%)  
Pneumonia viral   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
2/1641 (0.12%)  
Croup infectious   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
1/1641 (0.06%)  
Otitis media   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
1/1641 (0.06%)  
Arthritis bacterial   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Meningitis pneumococcal   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
2/1641 (0.12%)  
Otitis media acute   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Subcutaneous abscess   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
2/1641 (0.12%)  
Tonsillitis   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Urinary tract infection   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
2/1641 (0.12%)  
Acquired immunodeficiency syndrome   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Respiratory tract infection   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Staphylococcal skin infection   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Abscess   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Abscess neck   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Cerebral malaria   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Eczema infected   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Febrile infection   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Herpes simplex   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Klebsiella bacteremia   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Meningitis bacterial   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Nosocomial infection   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Parotid abscess   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Pharyngotonsillitis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Pneumonia bacterial   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Postoperative wound infection   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Respiratory tract infection viral   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Sepsis neonatal   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Septic shock   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Tuberculosis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Varicella   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Viral tonsillitis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Viral upper respiratory tract infection   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Cellulitis   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Disseminated tuberculosis   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Empyema   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Escherichia urinary tract infection   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Infection   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Meningitis tuberculous   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Perianal abscess   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Injury, poisoning and procedural complications        
Thermal burn   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Brachial plexus injury   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Fractured skull depressed   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Head injury   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Femur fracture   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Injury   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Pneumonitis chemical   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Soft tissue injury   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Therapeutic agent toxicity   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Metabolism and nutrition disorders        
Dehydration   *
      # participants affected / at risk
3/1647 (0.18%)  
2/1651 (0.12%)  
5/3298 (0.15%)  
2/1641 (0.12%)  
Kwashiorkor   *
      # participants affected / at risk
3/1647 (0.18%)  
1/1651 (0.06%)  
4/3298 (0.12%)  
4/1641 (0.24%)  
Malnutrition   *
      # participants affected / at risk
5/1647 (0.30%)  
0/1651 (0.00%)  
5/3298 (0.15%)  
0/1641 (0.00%)  
Marasmus   *
      # participants affected / at risk
0/1647 (0.00%)  
2/1651 (0.12%)  
2/3298 (0.06%)  
1/1641 (0.06%)  
Metabolic acidosis   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
3/1641 (0.18%)  
Hypernatraemia   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
2/1641 (0.12%)  
Hypokalaemia   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Hyponatraemic syndrome   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Cachexia   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Electrolyte imbalance   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Hypoglycaemic seizure   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Neuroblastoma   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Nervous system disorders        
Febrile convulsion   *
      # participants affected / at risk
1/1647 (0.06%)  
5/1651 (0.30%)  
6/3298 (0.18%)  
5/1641 (0.30%)  
Encephalitis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
2/1641 (0.12%)  
Status epilepticus   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Convulsion   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Fontanelle bulging   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
1/1641 (0.06%)  
Hydrocephalus   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
2/1641 (0.12%)  
Renal and urinary disorders        
Renal failure   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Respiratory, thoracic and mediastinal disorders        
Asthma   *
      # participants affected / at risk
1/1647 (0.06%)  
1/1651 (0.06%)  
2/3298 (0.06%)  
2/1641 (0.12%)  
Pneumonia aspiration   *
      # participants affected / at risk
2/1647 (0.12%)  
0/1651 (0.00%)  
2/3298 (0.06%)  
0/1641 (0.00%)  
Asphyxia   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Aspiration   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Bronchospasm   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Epistaxis   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Respiratory arrest   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Respiratory failure   *
      # participants affected / at risk
0/1647 (0.00%)  
1/1651 (0.06%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
Atelectasis   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Dyspnea   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Grunting   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Pneumothorax   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Respiratory distress   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Skin and subcutaneous tissue disorders        
Eczema   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Urticaria   *
      # participants affected / at risk
0/1647 (0.00%)  
0/1651 (0.00%)  
0/3298 (0.00%)  
1/1641 (0.06%)  
Surgical and medical procedures        
Adenoidectomy   *
      # participants affected / at risk
1/1647 (0.06%)  
0/1651 (0.00%)  
1/3298 (0.03%)  
0/1641 (0.00%)  
* Indicates events were collected by non-systematic assessment.


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


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: GSK ( Study Director )
Study ID Numbers: 102248, 111274
Study First Received: October 18, 2005
Results First Received: June 18, 2009
Last Updated: August 13, 2009
ClinicalTrials.gov Identifier: NCT00241644     History of Changes
Health Authority: South Africa: Medicines Control Council





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