Text Size

Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01153893
First received: June 29, 2010
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: February 9, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Pneumococcal Disease
Interventions: Biological: Pneumococcal vaccine GSK1024850A
Biological: InfanrixTM

  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
The duration of the study depends on the group allocation. The duration of the study per subject can vary from 1 month (Synflorix/Infanrix primed Group) to 3 months (Synflorix/Infanrix unprimed Group).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Because of an issue with the informed consent of a child, the data of the child, who had a non-related to study medication serious adverse event, are not detailed in this analysis. Data were reanalyzed for the 104 subjects with data available.

Reporting Groups
  Description
Synflorix/Infanrix Primed Group Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Synflorix/Infanrix Unprimed Group Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Participant Flow:   Overall Study
    Synflorix/Infanrix Primed Group     Synflorix/Infanrix Unprimed Group  
STARTED     68 [1]   36  
COMPLETED     67 [2]   36 [3]
NOT COMPLETED     1     0  
Adverse Event                 1                 0  
[1] Issues with the informed consent obtained from one child led to related data not used in this report
[2] Number of subjects who completed the follow-up visit at Month 1.
[3] Number of subjects who completed the follow-up visit at Month 3.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Synflorix/Infanrix Primed Group Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Synflorix/Infanrix Unprimed Group Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Total Total of all reporting groups

Baseline Measures
    Synflorix/Infanrix Primed Group     Synflorix/Infanrix Unprimed Group     Total  
Number of Participants  
[units: participants]
 		  68     36     104  
Age  
[units: Months]
Mean ± Standard Deviation 		  16.7  ± 1.00     16.4  ± 0.91     16.55  ± 0.955  
Gender  
[units: Subjects]
 		     
Female     29     17     46  
Male     39     19     58  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).   [ Time Frame: Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group. ]
  Show Outcome Measure 1

2.  Secondary:   Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.   [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]
  Show Outcome Measure 2

3.  Secondary:   Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.   [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]
  Show Outcome Measure 3

4.  Secondary:   Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.   [ Time Frame: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]
  Show Outcome Measure 4

5.  Secondary:   Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.   [ Time Frame: One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]
  Show Outcome Measure 5

6.  Secondary:   Concentration of Antibodies Against Protein D (PD).   [ Time Frame: Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.   [ Time Frame: Within 4 days (Days 0-3) after vaccination. ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.   [ Time Frame: Within 4 days (Days 0-3) after vaccination. ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Reporting Unsolicited AEs.   [ Time Frame: Within 31 days (Days 0-30) after vaccination ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Number of Subjects Reporting Unsolicited AEs.
Measure Description Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame Within 31 days (Days 0-30) after vaccination  
Safety Issue No  

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.
The Total Vaccinated cohort included all vaccinated subjects.

Reporting Groups
  Description
Synflorix/Infanrix Primed Group Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Synflorix/Infanrix Unprimed Group Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.

Measured Values
    Synflorix/Infanrix Primed Group     Synflorix/Infanrix Unprimed Group  
Number of Participants Analyzed  
[units: participants]
 		  68     36  
Number of Subjects Reporting Unsolicited AEs.  
[units: Subjects]
 		  31     18  

No statistical analysis provided for Number of Subjects Reporting Unsolicited AEs.



10.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group. ]
  Show Outcome Measure 10


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show 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
Data were reanalyzed because an issue was discovered with the informed consent obtained for one child after the original statistical analysis. The child’s parent requested GlaxoSmithKline not to use the data of their child.  


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


No publications provided


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153893     History of Changes
Other Study ID Numbers: 113199
Study First Received: June 29, 2010
Results First Received: February 9, 2012
Last Updated: September 27, 2012
Health Authority: Nigeria: National Agency for Food and Drug Administration and Control