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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: October 26, 2016
Last verified: October 2016
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: Acellular Pertussis
Diphtheria
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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™.

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 
Overall Participants Analyzed 
[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: Participants]
Count of Participants
     
Female      113  46.3%      111  49.8%      224  48.0% 
Male      131  53.7%      112  50.2%      243  52.0% 


  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



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: October 26, 2016
Health Authority: China: Food and Drug Administration