We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970307
First Posted: September 2, 2009
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: March 3, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions: Tetanus
Diphtheria
Haemophilus Influenzae Type b
Poliomyelitis
Acellular Pertussis
Hepatitis B
Interventions: Biological: GSK2202083A vaccine
Biological: 10-valent pneumococcal vaccine (GSK 1024850A)
Biological: Infanrix hexa™
Biological: Menjugate®

  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
GSK2202083A + Synflorix Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Infanrix Hexa + Menjugate Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Infanrix Hexa + Synflorix Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.

Participant Flow:   Overall Study
    GSK2202083A + Synflorix Group   Infanrix Hexa + Menjugate Group   Infanrix Hexa + Synflorix Group
STARTED   141   139   141 
COMPLETED   138   136   139 
NOT COMPLETED   3   3   2 
Serious Adverse Event                1                0                0 
Withdrawal by Subject                2                3                2 



  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
GSK2202083A + Synflorix Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Infanrix Hexa + Menjugate Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Infanrix Hexa + Synflorix Group Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
Total Total of all reporting groups

Baseline Measures
   GSK2202083A + Synflorix Group   Infanrix Hexa + Menjugate Group   Infanrix Hexa + Synflorix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 141   139   141   421 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 8.5  (0.98)   8.7  (1.02)   8.7  (1.13)   8.63  (1.05) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      74  52.5%      86  61.9%      68  48.2%      228  54.2% 
Male      67  47.5%      53  38.1%      73  51.8%      193  45.8% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
White-Caucasian/European heritage   141   139   141   421 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroprotected Subjects Against Polyribosyl-Ribitol-Phosphate (PRP)   [ Time Frame: At Month 3 ]

2.  Primary:   Number of Seroprotected Subjects Against Neisseria Meningitidis Serogroup C Using Baby Rabbit Complement (rSBA-MenC)   [ Time Frame: At Month 3 ]

3.  Secondary:   Anti-PRP Antibody Concentrations   [ Time Frame: At Months 0 and 3 ]

4.  Secondary:   Antibody Titers Against rSBA-MenC   [ Time Frame: At Months 0 and 3 ]

5.  Secondary:   Number of Seropositive Subjects for Anti-polysaccharide Neisseria Meningitidis Serogroup C (Anti-PSC)   [ Time Frame: At Month 3 ]

6.  Secondary:   Anti-PSC Antibody Concentrations   [ Time Frame: At Months 0 and 3 ]

7.  Secondary:   Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T)   [ Time Frame: At Month 3 ]

8.  Secondary:   Anti-D and Anti-T Antibody Concentrations   [ Time Frame: At Month 3 ]

9.  Secondary:   Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)   [ Time Frame: At Month 3 ]

10.  Secondary:   Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations   [ Time Frame: At Months 0 and 3 ]

11.  Secondary:   Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN   [ Time Frame: At Month 3 ]

12.  Secondary:   Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B Surface Antigen (Anti-HBs)   [ Time Frame: At Month 3 ]

13.  Secondary:   Anti-HBs Antibody Concentrations   [ Time Frame: At Month 3 ]

14.  Secondary:   Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3   [ Time Frame: At Month 3 ]

15.  Secondary:   Anti-polio Types 1, 2 and 3 Antibody Titers   [ Time Frame: At Month 3 ]

16.  Secondary:   Number of Seropositive Subjects for Anti-pneumococcal (Anti-pneumo) Serotypes   [ Time Frame: At Month 3 ]

17.  Secondary:   Anti-pneumo Antibody Concentrations   [ Time Frame: At Month 3 ]

18.  Secondary:   Number of Seropositive Subjects for Anti-protein D (Anti-PD)   [ Time Frame: At Month 3 ]

19.  Secondary:   Anti-PD Antibody Concentrations   [ Time Frame: At Month 3 ]

20.  Secondary:   Number of Subjects With Any Solicited Local Symptoms   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination ]

21.  Secondary:   Number of Subjects With Any Solicited General Symptoms   [ Time Frame: During the 8-day (Days 0-7) post-vaccination period after any vaccination ]

22.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Days 0-30) post-vaccination period after any vaccination ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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.


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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00970307     History of Changes
Other Study ID Numbers: 112157
First Submitted: August 27, 2009
First Posted: September 2, 2009
Results First Submitted: March 3, 2017
Results First Posted: April 14, 2017
Last Update Posted: May 30, 2017