Immunogenicity and Safety of GSK Biologicals' Infanrix/Hib in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00696423
First received: June 5, 2008
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: July 17, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Haemophilus Influenzae Type b Disease
Diphtheria
Pertussis
Tetanus
Interventions: Biological: Infanrix™
Biological: Hiberix™

  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
Infanrix/Hib Single Injection Group Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
Infanrix + Hiberix Separate Injection Group Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.

Participant Flow:   Overall Study
    Infanrix/Hib Single Injection Group     Infanrix + Hiberix Separate Injection Group  
STARTED     244     223  
COMPLETED     244     218  
NOT COMPLETED     0     5  
Lost to Follow-up                 0                 5  



  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
Infanrix/Hib Single Injection Group Subjects received 1 dose of Infanrix™ extemporaneously mixed with Hiberix™.
Infanrix + Hiberix Separate Injection Group Subjects received two separate injections, one of Infanrix™ and one of Hiberix™.
Total Total of all reporting groups

Baseline Measures
    Infanrix/Hib Single Injection Group     Infanrix + Hiberix Separate Injection Group     Total  
Number of Participants  
[units: participants]
  244     223     467  
Age  
[units: months]
Mean ± Standard Deviation
  19.2  ± 0.79     19.2  ± 0.75     19.2  ± 0.77  
Gender  
[units: subjects]
     
Female     113     111     224  
Male     131     112     243  



  Outcome Measures
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1.  Primary:   Anti-polyribosyl-ribitol-phosphate (PRP) Antibody Concentrations   [ Time Frame: One month after booster vaccination ]

2.  Primary:   Anti-diphtheria Toxoid Antibody Concentrations   [ Time Frame: One month after booster vaccination ]

3.  Primary:   Anti-tetanus Toxoid Antibody Concentrations   [ Time Frame: One month after booster vaccination ]

4.  Primary:   Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations   [ Time Frame: One month after booster vaccination ]

5.  Primary:   The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies   [ Time Frame: One month after booster vaccination ]

6.  Secondary:   Anti-PRP Antibody Concentrations   [ Time Frame: Before booster vaccination ]

7.  Secondary:   Anti-diphtheria Toxoid Antibody Concentrations   [ Time Frame: Before booster vaccination ]

8.  Secondary:   Anti-tetanus Toxoid Antibody Concentrations   [ Time Frame: Before booster vaccination ]

9.  Secondary:   Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations   [ Time Frame: Before booster vaccination ]

10.  Secondary:   The Number of Subjects Seroprotected for Anti-PRP, Anti-diphtheria and Anti-tetanus Antibodies and Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies   [ Time Frame: Before booster vaccination ]

11.  Secondary:   Number of Subjects Reporting Solicited Local and General Symptoms   [ Time Frame: During the 4-day follow-up period after booster vaccination ]

12.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: During the 31-day follow-up period after booster vaccination ]

13.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: During the 31-day follow-up period after booster vaccination ]


  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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00696423     History of Changes
Other Study ID Numbers: 111535
Study First Received: June 5, 2008
Results First Received: July 17, 2009
Last Updated: November 21, 2012
Health Authority: China: Food and Drug Administration