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A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00432380
First received: February 6, 2007
Last updated: September 5, 2017
Last verified: March 2017
Results First Received: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Infections, Rotavirus
Interventions: Biological: Rotarix™
Biological: Placebo

  Participant Flow
  Hide 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
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
Placebo-Rotarix-Rotarix Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Rotarix-Placebo-Rotarix Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Placebo Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.

Participant Flow:   Overall Study
    Placebo-Rotarix-Rotarix Group   Rotarix-Placebo-Rotarix Group   Placebo Group
STARTED   150   150   75 
COMPLETED   146   146   74 
NOT COMPLETED   4   4   1 
Migrated/moved from study area                3                4                1 
Adverse Event                1                0                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
Placebo-Rotarix-Rotarix Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Month 1 and Month 2, and a single oral dose of placebo at Day 0. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Rotarix-Placebo-Rotarix Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 2 oral doses of Rotarix™ liquid vaccine at Day 0 and Month 2, and a single oral dose of placebo at Month 1. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Placebo Group Healthy male or female infants between, and including, 5 to 10 weeks of age, were administered 3 oral doses of placebo at Day 0, Month 1 and Month 2. Subjects also received routine infant vaccinations according to the Expanded Program of Immunization (EPI) recommendations in Philippines.
Total Total of all reporting groups

Baseline Measures
   Placebo-Rotarix-Rotarix Group   Rotarix-Placebo-Rotarix Group   Placebo Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   75   375 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 6.6  (1.07)   6.5  (1)   6.6  (1.02)   6.56  (1.02) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      59  39.3%      76  50.7%      40  53.3%      175  46.7% 
Male      91  60.7%      74  49.3%      35  46.7%      200  53.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted Subjects for Anti-rotavirus (Anti-RV) Immunoglobulin A (IgA) Antibody   [ Time Frame: At Month 3 ]

2.  Secondary:   Number of Seroconverted Subjects for Anti-RV IgA Antibody   [ Time Frame: At Month 3 ]

3.  Secondary:   Serum IgA Antibody Concentrations Against Rotavirus   [ Time Frame: At Month 3 ]

4.  Secondary:   Number of Subjects Reporting Grade 2 or Grade 3 Fever, Vomiting or Diarrhea   [ Time Frame: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses ]

5.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 8-day (Days 0-7) period following each dose of study vaccine or placebo and across doses ]

6.  Secondary:   Number of Subjects Reporting RV in Gastroenteritis (GE) Episodes   [ Time Frame: From Dose 1 of study vaccine or placebo (at Day 0) up to Month 3 ]

7.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Event (AE)   [ Time Frame: During the 31-day (Days 0-30) period following any study vaccine dose or placebo ]

8.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 to Month 3) ]


  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:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00432380     History of Changes
Other Study ID Numbers: 109216
Study First Received: February 6, 2007
Results First Received: March 23, 2017
Last Updated: September 5, 2017