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To Assess Safety, Reactogenicity & Immunogenicity of 2 Doses of GSK's Oral Human Rotavirus Vaccine in Pre-Term Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00420745
First received: January 9, 2007
Last updated: June 12, 2014
Last verified: March 2011
Results First Received: March 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rotarix Group All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
Placebo Group All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.

Participant Flow:   Overall Study
    Rotarix Group     Placebo Group  
STARTED     670     339  
COMPLETED     655     333  
NOT COMPLETED     15     6  
Adverse Event                 2                 2  
Lost to Follow-up                 10                 2  
Protocol Violation                 1                 0  
Physician Decision                 1                 1  
Recurrent pneumonia & bronchitis                 0                 1  
Age limit exceeded for Dose 2                 1                 0  



  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 Group All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
Placebo Group All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
Total Total of all reporting groups

Baseline Measures
    Rotarix Group     Placebo Group     Total  
Number of Participants  
[units: participants]
  670     339     1009  
Age  
[units: weeks]
Mean ± Standard Deviation
  8.5  ± 1.77     8.5  ± 1.78     8.5  ± 1.77  
Gender  
[units: participants]
     
Female     327     167     494  
Male     343     172     515  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Any Serious Adverse Events (SAEs).   [ Time Frame: From Day 0 up to 1 month after Dose 2 of Rotarix vaccine/Placebo ]

2.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs), According to Medical Dictionary for Regulatory Activities (MedDRA) Classification.   [ Time Frame: Within 31 days after any Rotarix vaccine/Placebo dose. ]

3.  Secondary:   Number of Subjects for Whom Each Type of Solicited Symptom Was Reported.   [ Time Frame: Within 15 days after each Rotarix vaccine/Placebo dose. ]

4.  Secondary:   Number of Subjects for Whom Presence of Rotavirus (RV) Gastroenteritis (GE) Was Detected in Stools.   [ Time Frame: From Dose 1 up to 1 month after Dose 2 of Rotarix vaccine/Placebo ]

5.  Secondary:   Seroconversion to Anti-rotavirus Immunoglobulin A (IgA) Antibody.   [ Time Frame: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo ]

6.  Secondary:   Serum Anti–Rotavirus IgA Antibody Concentration.   [ Time Frame: At Visit 3, 1 month after Dose 2 of Rotarix vaccine/Placebo ]


  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
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  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:
Omenaca F et al. Safety, Reactogenicity and Immunogenicity of RIX4414 Live Attenuated Human Rotavirus Vaccine in Pre-Term Infants. Abstract presented at the ICAAC/IDSA Joint Meeting, Washington DC, US, 25-28 October 2008.
Omenaca F et al. (2012) Safety, reactogenicity and immunogenicity of the human rotavirus vaccine in preterm European infants: a randomized phase IIIb study. Pediatr Infect Dis J. 31(5):487-493.

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00420745     History of Changes
Other Study ID Numbers: 106481
Study First Received: January 9, 2007
Results First Received: March 13, 2009
Last Updated: June 12, 2014
Health Authority: Spain: Spanish Agency of Medicines