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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: November 3, 2016
Last verified: November 2016
Results First Received: March 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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.
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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 
Overall Participants Analyzed 
[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]
Count of Participants
     
Female      327  48.8%      167  49.3%      494  49.0% 
Male      343  51.2%      172  50.7%      515  51.0% 


  Outcome Measures
  Show All Outcome Measures

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. Immunogenicity of a rotavirus vaccine (RIX4414) in European pre-term infants with different gestational age. Abstract presented at the 27th annual ESPID meeting, Brussels, Belgium, 9-13 June 2009.
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.


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: November 3, 2016