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To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-dose Vaccination (Infants)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00363545
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: Lyophilized formulation of HRV vaccine
Biological: Liquid formulation of HRV vaccine

  Participant Flow

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
Liquid Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Lyophilized Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.

Participant Flow:   Overall Study
    Liquid Rotarix Group   Lyophilized Rotarix Group
STARTED   636   638 
COMPLETED   592   581 
NOT COMPLETED   44   57 
Serious Adverse Event                0                1 
Withdrawal by Subject                12                15 
Migrated/moved from study area                3                6 
Lost to follow-up (incompl. vaccination)                14                18 
Lost to follow-up (complete vaccination)                14                17 
Others                1                0 



  Baseline Characteristics

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
Liquid Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the liquid formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Lyophilized Rotarix Group Healthy male and female infants, between and including 6-12 weeks of age, who received two oral doses of the lyophilized formulation of the Rotarix™ vaccine, according to a 0, 2 month schedule.
Total Total of all reporting groups

Baseline Measures
   Liquid Rotarix Group   Lyophilized Rotarix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 636   638   1274 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 8.6  (0.87)   8.6  (0.86)   8.6  (0.86) 
Gender 
[Units: Participants]
Count of Participants
     
Female      294  46.2%      316  49.5%      610  47.9% 
Male      342  53.8%      322  50.5%      664  52.1% 


  Outcome Measures

1.  Primary:   Number of Seroconverted Subjects Against Human Rotavirus   [ Time Frame: At 1 to 2 months after the second vaccine dose (Months 3-4) ]

2.  Secondary:   Concentrations of Anti-rotavirus IgA Antibodies   [ Time Frame: At 1 to 2 months after the second vaccine dose (Months 3-4) ]

3.  Secondary:   Number of Subjects With Vaccine Take for Anti-rotavirus IgA Antibodies   [ Time Frame: At 1 to 2 months after the second vaccine dose (Months 3-4) ]

4.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 15-day (Day 0-14) follow-up period, after each vaccine dose and across doses ]

5.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: Within 31 days after any vaccine dose (Day 0-30) ]

6.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Throughout the entire study period (from Day 0 to Month 4) ]

7.  Secondary:   Number of Subjects With Rotavirus in Stool Samples Collected During Gastroenteritis Episodes   [ Time Frame: From the first vaccine dose (Dose 1) up to Month 4 ]


  Serious Adverse Events


  Other Adverse Events


  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
None reported.


  More Information

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:
Velasquez AA et al. Immunogenicity of The Oral Live Attenuated Human Rotavirus Vaccine RIX4414 (Rotarix™) Oral Suspension (Liquid Formulation) Co-administered with Childhood Vaccinations in Panama. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00363545     History of Changes
Other Study ID Numbers: 107077
First Submitted: August 11, 2006
First Posted: August 15, 2006
Results First Submitted: January 5, 2017
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017