Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00611559
First received: January 29, 2008
Last updated: October 15, 2009
Last verified: October 2009
Results First Received: June 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Diphtheria
Tetanus
Pertussis
Hepatitis B
Poliomyelitis
Haemophilus Influenzae Type b Disease
Interventions: Biological: Infanrix™ penta
Biological: Infanrix™ hexa

  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
No text entered.

Reporting Groups
  Description
Infanrix Hexa Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Infanrix Hexa Preservative-containing Formulation Group Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Infanrix Penta Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta

Participant Flow:   Overall Study
    Infanrix Hexa Preservative-free Formulation Group     Infanrix Hexa Preservative-containing Formulation Group     Infanrix Penta Preservative-free Formulation Group  
STARTED     111     115     57  
COMPLETED     110     114     56  
NOT COMPLETED     1     1     1  
Lost to Follow-up                 0                 1                 0  
Protocol Violation                 1                 0                 1  



  Baseline Characteristics
  Hide 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
Infanrix Hexa Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Infanrix Hexa Preservative-containing Formulation Group Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Infanrix Penta Preservative-free Formulation Group Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
Total Total of all reporting groups

Baseline Measures
    Infanrix Hexa Preservative-free Formulation Group     Infanrix Hexa Preservative-containing Formulation Group     Infanrix Penta Preservative-free Formulation Group     Total  
Number of Participants  
[units: participants]
  111     115     57     283  
Age  
[units: months]
Mean ± Standard Deviation
  21.2  ± 1.61     21.3  ± 1.57     21.2  ± 1.62     21.2  ± 1.59  
Gender  
[units: subjects]
       
Female     56     46     35     137  
Male     55     69     22     146  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose   [ Time Frame: One month after the booster dose ]

2.  Primary:   Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose   [ Time Frame: One month after the booster dose ]

3.  Primary:   Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose   [ Time Frame: One month after the booster dose ]

4.  Primary:   Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose   [ Time Frame: One month after the booster dose ]

5.  Primary:   Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose   [ Time Frame: One month after the booster dose ]

6.  Secondary:   Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

7.  Secondary:   Anti-HB Antibodies Concentration   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

8.  Secondary:   Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

9.  Secondary:   Anti-PRP Antibodies Concentration   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

10.  Secondary:   Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose   [ Time Frame: Before the booster dose administration (at baseline) ]

11.  Secondary:   Anti-diphtheria and Anti-tetanus Antibodies Concentration   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

12.  Secondary:   Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

13.  Secondary:   Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose   [ Time Frame: Before the booster dose administration (at baseline) ]

14.  Secondary:   Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose   [ Time Frame: Before the booster dose ]

15.  Secondary:   Anti-poliovirus Antibodies Titer   [ Time Frame: Before (Pre) and one month after (Post) the booster dose ]

16.  Secondary:   Number of Subjects Reporting Solicited Symptoms   [ Time Frame: Within the 4-day (Day 0-3) post-vaccination period ]

17.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AE)   [ Time Frame: Within the 31-day (Day 0-30) post-vaccination period ]

18.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAE)   [ Time Frame: Up to one month after the booster dose administration ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide 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.


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


Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00611559     History of Changes
Other Study ID Numbers: 110478
Study First Received: January 29, 2008
Results First Received: June 22, 2009
Last Updated: October 15, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation