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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01204658
First received: September 16, 2010
Last updated: September 29, 2016
Last verified: August 2016
Results First Received: August 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Infections, Streptococcal
Interventions: Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
Biological: Synflorix
Biological: Prevenar 13
Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)

  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
A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).

Reporting Groups
  Description
10PP-LD/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
10PP-HD/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
Synflorix/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
Prevnar 13/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.

Participant Flow for 2 periods

Period 1:   Primary Phase
    10PP-LD/Infanrix Hexa Group   10PP-HD/Infanrix Hexa Group   Synflorix/Infanrix Hexa Group   Prevnar 13/Infanrix Hexa Group
STARTED   146   142   145   142 
COMPLETED   146   142   144   142 
NOT COMPLETED   0   0   1   0 
Adverse Event                0                0                1                0 

Period 2:   Booster Phase
    10PP-LD/Infanrix Hexa Group   10PP-HD/Infanrix Hexa Group   Synflorix/Infanrix Hexa Group   Prevnar 13/Infanrix Hexa Group
STARTED   144   140   140   140 
COMPLETED   144   140   140   140 
NOT COMPLETED   0   0   0   0 



  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
10PP-LD/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
10PP-HD/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
Synflorix/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
Prevnar 13/Infanrix Hexa Group This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
Total Total of all reporting groups

Baseline Measures
   10PP-LD/Infanrix Hexa Group   10PP-HD/Infanrix Hexa Group   Synflorix/Infanrix Hexa Group   Prevnar 13/Infanrix Hexa Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 146   142   145   142   575 
Age 
[Units: Weeks]
Mean (Standard Deviation)
 10.3  (2.49)   10.1  (2.70)   10.1  (2.61)   10.2  (2.64)   10.2  (2.61) 
Gender 
[Units: Participants]
         
Female   65   67   70   66   268 
Male   81   75   75   76   307 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination – Primary Phase of the Study   [ Time Frame: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course ]

2.  Primary:   Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses ]

3.  Primary:   Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses ]

4.  Secondary:   Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

5.  Secondary:   Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

6.  Secondary:   Antibody Concentrations Against Protein D (Anti-PD) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

7.  Secondary:   Antibody Concentrations Against Protein D (Anti-PD) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

8.  Secondary:   Antibody Concentrations Against Pneumococcal Serotypes – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

9.  Secondary:   Antibody Concentrations Against Pneumococcal Serotypes – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

10.  Secondary:   Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

11.  Secondary:   Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

12.  Secondary:   Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

13.  Secondary:   Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

14.  Secondary:   Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

15.  Secondary:   Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

16.  Secondary:   Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

17.  Secondary:   Concentrations of Antibodies Against Hepatitis B (Anti-HBs) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

18.  Secondary:   Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

19.  Secondary:   Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

20.  Secondary:   Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

21.  Secondary:   Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]

22.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Primary Phase of the Study   [ Time Frame: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course ]

23.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms – Booster Phase of the Study   [ Time Frame: Within the 7-day (Days 0-6) period after booster vaccination ]

24.  Secondary:   Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination – Booster Phase of the Study   [ Time Frame: Within the 7-day (Days 0-6) period post vaccination after booster vaccination ]

25.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs) – Primary Phase of the Study   [ Time Frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses ]

26.  Secondary:   Number of Subjects With Unsolicited Adverse Events (AEs) – Booster Phase of the Study   [ Time Frame: Within the 31-day (Days 0-30) period post booster vaccination ]

27.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (Months 0-11) ]

28.  Secondary:   Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Primary Phase of the Study   [ Time Frame: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]
Results not yet reported.   Anticipated Reporting Date:   12/2050   Safety Issue:   No

29.  Secondary:   Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity – Booster Phase of the Study   [ Time Frame: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) ]
Results not yet reported.   Anticipated Reporting Date:   12/2050   Safety Issue:   No


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01204658     History of Changes
Other Study ID Numbers: 113994
Study First Received: September 16, 2010
Results First Received: August 5, 2016
Last Updated: September 29, 2016
Health Authority: Germany: Paul-Ehrlich-Institut
Sweden: Läkemedelsverket - Medical Products Agency
Poland: Ministry of Health: Ewa Kopacz
Czech Republic: State Institute for Drug Control