Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197236
First received: September 15, 2005
Last updated: April 11, 2013
Last verified: March 2011
Results First Received: December 2, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Hepatitis A Vaccine
Hepatitis A
Interventions: Biological: Havrix™
Biological: Infanrix™
Biological: ActHIB™

  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
Of the total of 468 subjects enrolled, only 394 were vaccinated and as such considered as 'started'.

Reporting Groups
  Description
Havrix Group Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
Havrix + Infanrix + ActHIB Group Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.

Participant Flow:   Overall Study
    Havrix Group     Havrix + Infanrix + ActHIB Group     Infanrix + ActHIB→Havrix Group  
STARTED     135     127     132  
COMPLETED     121     110     109  
NOT COMPLETED     14     17     23  
Adverse Event                 1                 0                 1  
Lost to Follow-up                 5                 14                 6  
Protocol Violation                 0                 0                 1  
Withdrawal by Subject                 7                 3                 11  
Study drug/medication expiration                 1                 0                 3  
Returned out of specified time window                 0                 0                 1  



  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
Havrix Group Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
Havrix + Infanrix + ActHIB Group Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
Infanrix + ActHIB→Havrix Group Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
Total Total of all reporting groups

Baseline Measures
    Havrix Group     Havrix + Infanrix + ActHIB Group     Infanrix + ActHIB→Havrix Group     Total  
Number of Participants  
[units: participants]
  135     127     132     394  
Age  
[units: months]
Mean ± Standard Deviation
  15.1  ± 0.36     15.1  ± 0.3     15.0  ± 0.21     15.1  ± 0.30  
Gender  
[units: subjects]
       
Female     55     64     67     186  
Male     80     63     65     208  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix   [ Time Frame: 31 days following the second dose of Havrix™ ]

2.  Primary:   Number of Anti-diphtheria, Anti-tetanus and Anti-polyribosylribitol Phosphate (PRP) Seroprotected Subjects   [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ]

3.  Primary:   Number of Vaccine Responders for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (PRN)   [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ]

4.  Secondary:   Anti-diphtheria and Anti-tetanus Antibody Geometric Mean Concentrations (GMC)   [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ]

5.  Secondary:   Anti-polyribosylribitol Phosphate (PRP) Antibody Geometric Mean Concentrations (GMC)   [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ]

6.  Secondary:   Number of Subjects Seropositive for Anti-pertussis Toxoid (PT), Anti-filamentous Hemagglutinin (FHA), Anti-pertactin (PRN) and Anti-polyribosylribitol Phosphate (PRP)   [ Time Frame: 31 days following the administration of Infanrix™ and ActHIB ]

7.  Secondary:   Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the First Dose of Havrix   [ Time Frame: 31 days following the first dose of Havrix™ ]

8.  Secondary:   Anti-hepatitis A Virus (HAV) Antibody Geometric Mean Concentrations (GMC) Following the First Dose of Havrix   [ Time Frame: 31 days following the first dose of Havrix™ ]

9.  Secondary:   Anti-hepatitis Virus A (HAV) Antibody Geometric Mean Concentrations (GMC) Following the Second Dose of Havrix   [ Time Frame: 31 days following the second dose of Havrix™ ]

10.  Secondary:   Number of Subjects With Vaccine Response to Havrix™.   [ Time Frame: 31 days following the second dose ]

11.  Secondary:   Number of Subjects Reporting Solicited Local Adverse Events (AEs)   [ Time Frame: 4-day period following each dose of study vaccine(s) ]

12.  Secondary:   Number of Subjects Reporting Solicited General Adverse Events (AEs)   [ Time Frame: 4-day period following each dose of study vaccine(s) ]

13.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: 31-day period following each dose of study vaccine(s) ]

14.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs), New Chronic Illnesses and Medically Significant Events   [ Time Frame: Active Phase and the 6-months Extended Safety Follow-up (ESFU) Phase. ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197236     History of Changes
Other Study ID Numbers: 208109/232
Study First Received: September 15, 2005
Results First Received: December 2, 2008
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration