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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00985751
First Posted: September 28, 2009
Last Update Posted: October 6, 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: May 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Infections, Streptococcal
Interventions: Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Biological: Pneumococcal vaccine GSK1024850A

  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
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
GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix/GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix/GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).

Participant Flow:   Overall Study
    GSK 2189242A-LD Group   GSK 2189242A-HD Group   Synflorix/GSK 2189242A-LD Group   Synflorix/GSK 2189242A-HD Group   Synflorix Group
STARTED   51   52   52   51   51 
COMPLETED   51   52   52   51   50 
NOT COMPLETED   0   0   0   0   1 
Adverse Event                0                0                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
GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of GSK Biologicals’ candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix/GSK 2189242A-LD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix/GSK 2189242A-HD Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Synflorix Group Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
Total Total of all reporting groups

Baseline Measures
   GSK 2189242A-LD Group   GSK 2189242A-HD Group   Synflorix/GSK 2189242A-LD Group   Synflorix/GSK 2189242A-HD Group   Synflorix Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   52   52   51   51   257 
Age 
[Units: Months]
Mean (Standard Deviation)
 17  (3.6)   16.7  (3.81)   17.1  (4.03)   16.8  (3.96)   16.3  (4.18)   16.78  (3.90) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      25  49.0%      22  42.3%      23  44.2%      29  56.9%      28  54.9%      127  49.4% 
Male      26  51.0%      30  57.7%      29  55.8%      22  43.1%      23  45.1%      130  50.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
           
White-Caucasian/European heritage   51   52   51   51   49   254 
White-Arabic/North African heritage   0   0   1   0   2   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Fever > 40.0°C (Rectal Temperature)   [ Time Frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination ]

2.  Primary:   Number of Subjects With Fever > 40.0°C (Rectal Temperature)   [ Time Frame: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination ]

3.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose) ]

4.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose) ]

5.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Days 0-30) follow-up period after each primary dose ]

6.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs)   [ Time Frame: During the 31-day (Days 0-30) follow-up period after the booster dose ]

7.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7) ]

8.  Secondary:   Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations   [ Time Frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) ]

9.  Secondary:   Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations   [ Time Frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) ]

10.  Secondary:   Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes   [ Time Frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) ]

11.  Secondary:   Antibody Concentrations to Protein D (Anti-PD)   [ Time Frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) ]

12.  Secondary:   Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity   [ Time Frame: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7) ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985751     History of Changes
Other Study ID Numbers: 113171
First Submitted: September 24, 2009
First Posted: September 28, 2009
Results First Submitted: May 11, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017