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Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00241644
First received: October 18, 2005
Last updated: April 11, 2013
Last verified: November 2012
Results First Received: June 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Rotavirus Vaccines
Interventions: Biological: Rotarix™
Biological: 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
Only subjects from Malawi and from Cohort 2 South Africa were asked to continue the study for a second follow-up period (Year 2).

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'.

For the second follow-up period, as mentioned in the protocol the results are presented for Rotarix Pooled and Placebo Groups only.


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.
Rotarix Pooled Group Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).

Participant Flow for 2 periods

Period 1:   First Efficacy Period (Year 1)
    Rotarix 2-dose Group     Rotarix 3-dose Group     Placebo Group     Rotarix Pooled Group  
STARTED     1647     1651     1641     3298  
COMPLETED     1420     1383     1392     2803  
NOT COMPLETED     227     268     249     495  
Adverse Event                 46                 45                 45                 91  
Protocol Violation                 3                 5                 4                 8  
Withdrawal by Subject                 59                 74                 81                 133  
Lost to Follow-up                 116                 142                 116                 258  
Non-compliance                 2                 1                 2                 3  
Return dates not reliable                 1                 0                 0                 1  
Vaccinated at regular clinic                 0                 0                 1                 0  
Subject's parent passed away                 0                 1                 0                 1  

Period 2:   Second Efficacy Period (Year 2)
    Rotarix 2-dose Group     Rotarix 3-dose Group     Placebo Group     Rotarix Pooled Group  
STARTED     771     754     746     1525  
COMPLETED     710     697     682     1407  
NOT COMPLETED     61     57     64     118  
Adverse Event                 11                 9                 12                 20  
Protocol Violation                 2                 1                 2                 3  
Withdrawal by Subject                 4                 3                 2                 7  
Lost to Follow-up                 43                 43                 46                 86  
Consenting parent passed away                 1                 1                 2                 2  



  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
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.
Rotarix Pooled Group Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
Total Total of all reporting groups

Baseline Measures
    Rotarix 2-dose Group     Rotarix 3-dose Group     Placebo Group     Rotarix Pooled Group     Total  
Number of Participants  
[units: participants]
  1647     1651     1641     3298     8237  
Age  
[units: weeks]
Mean ± Standard Deviation
  6.3  ± 0.92     6.4  ± 0.98     6.4  ± 0.97     6.4  ± 0.95     6.4  ± 0.95  
Gender  
[units: subjects]
         
Female     811     839     800     1650     4100  
Male     836     812     841     1648     4137  



  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   [ Time Frame: From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

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

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

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

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

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

7.  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   [ Time Frame: From 2 weeks after the last vaccine or placebo dose up to 1 year of age ]

8.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains   [ Time Frame: During the period from 2 weeks after the last dose of vaccine or placebo until study end ]

9.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis (RV GE) Caused by the Circulating Wild-type Rotavirus Strains   [ Time Frame: During the period from 1 year of age to study end ]

10.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains   [ Time Frame: During the period from 2 weeks after the last dose of vaccine or placebo until study end ]

11.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects Hospitalized and/or With Supervised Re-hydration Therapy Due to Rotavirus Gastroenteritis (RV GE) Episode Caused by the Circulating Wild-type RV Strains   [ Time Frame: During the period from 1 year of age to study end ]

12.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type   [ Time Frame: During the period from 2 weeks after the last dose of vaccine or placebo until study end ]

13.  Secondary:   For Subjects in Cohort 2 South Africa and the Cohort in Malawi: Number of Subjects With Severe Rotavirus Gastroenteritis Caused by the Circulating Wild-type Rotavirus Strains, Classified by Rotavirus Type   [ Time Frame: During the period from 1 year of age to study end ]

14.  Secondary:   Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) Leading to Drop Out   [ Time Frame: From the first dose of vaccine or placebo up to end of the study ]

15.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: From the first dose of vaccine or placebo up to end of the study ]

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

17.  Secondary:   Number of Seroconverted Subjects   [ Time Frame: One month after the last vaccine or placebo dose ]

18.  Secondary:   Geometric Mean Concentration of Anti-rotavirus Immunoglobulin A (IgA) Antibodies   [ Time Frame: One month after the last vaccine or placebo dose ]

19.  Secondary:   Number of Seropositive Subjects   [ Time Frame: One month after the last vaccine or placebo dose ]


  Serious Adverse Events


  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
No text entered.


  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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Cunliffe NA et al. (2012) Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: A randomized, double-blind, placebo controlled trial. Vaccine. 30(1)36-43.
Steele D et al. Diverse circulating rotavirus strains during the first year of life in African infants. Abstract presented at 10th International symposium on dsRNA Viruses, Hamilton Island, QLD, Australia, 21-25 June 2009.
Steele AD et al. Efficacy of human rotavirus vaccine, Rotarix™ against severe gastroenteritis caused by diverse circulating rotavirus strains in African infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). Melbourne, Australia, 16-19 November 2011.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00241644     History of Changes
Obsolete Identifiers: NCT00598468
Other Study ID Numbers: 102248
Study First Received: October 18, 2005
Results First Received: June 18, 2009
Last Updated: April 11, 2013
Health Authority: South Africa: Medicines Control Council