ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01153893
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : March 15, 2012
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Infections, Streptococcal
Interventions: Biological: Pneumococcal vaccine GSK1024850A
Biological: InfanrixTM

  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

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
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 
Overall Participants Analyzed 
[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

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. ]

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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. ]


  Serious Adverse Events


  Other Adverse Events


  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.


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153893     History of Changes
Other Study ID Numbers: 113199
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: February 9, 2012
Results First Posted: March 15, 2012
Last Update Posted: October 20, 2016