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An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01439360
First received: September 21, 2011
Last updated: January 16, 2017
Last verified: January 2017
Results First Received: December 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza
Interventions: Biological: Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Biological: Havrix Junior
Biological: Prevenar 13
Biological: Varivax/ProVarivax
Biological: Varilrix

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
Control In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).

Participant Flow:   Overall Study
    D-QIV   Control
STARTED   6006   6012 
COMPLETED   5808   5804 
NOT COMPLETED   198   208 
Adverse Event                4                16 
Lost to Follow-up                43                58 
Others                10                5 
Protocol Violation                1                0 
Withdrawal by Subject                140                129 



  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
D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
Control In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
Total Total of all reporting groups

Baseline Measures
   D-QIV   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 6006   6012   12018 
Age 
[Units: Months]
Mean (Standard Deviation)
 21.9  (8.0)   21.8  (8.0)   21.9  (8.0) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2933  48.8%      2925  48.7%      5858  48.7% 
Male      3073  51.2%      3087  51.3%      6160  51.3% 
Race/Ethnicity, Customized 
[Units: Participants]
     
African Heritage / African American   24   20   44 
Asian - Central/South Asian Heritage   1062   1053   2115 
Asian - East Asian Heritage   2   0   2 
Asian - Japanese Heritage   2   0   2 
Asian - South East Asian Heritage   1661   1666   3327 
Native Hawaiian or Other Pacific Islander   3   0   3 
Other   1639   1642   3281 
White - Arabic / North African Heritage   142   149   291 
White - Caucasian / European Heritage   1471   1482   2953 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

2.  Primary:   Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

3.  Secondary:   Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.   [ Time Frame: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) ]

4.  Secondary:   Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

5.  Secondary:   Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

6.  Secondary:   Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

7.  Secondary:   Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

8.  Secondary:   Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.   [ Time Frame: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) ]

9.  Secondary:   Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.   [ Time Frame: During the surveillance period (approximately 6 to 8 months) ]

10.  Secondary:   Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)   [ Time Frame: At Days 0 and 28/56 ]

11.  Secondary:   Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)   [ Time Frame: At Day 0 and Day 28/56 ]

12.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)   [ Time Frame: At Day 28/56 (POST) ]

13.  Secondary:   Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).   [ Time Frame: At Day 28/56 (POST) ]

14.  Secondary:   Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)   [ Time Frame: At Day 0 and Day 28/56 ]

15.  Secondary:   Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

16.  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 ]

17.  Secondary:   Duration of Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

18.  Secondary:   Duration of Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

19.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)   [ Time Frame: During the 28-day (Days 0-27) post-vaccination period ]

20.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)   [ Time Frame: During the entire study period (approximately 6- 8 months per subject) ]

21.  Secondary:   Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).   [ Time Frame: During the entire study period (approximately 6- 8 months per subject) ]

22.  Secondary:   Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (approximately 6- 8 months per subject) ]


  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: NCT01439360     History of Changes
Other Study ID Numbers: 115345
2011-000758-41 ( EudraCT Number )
Study First Received: September 21, 2011
Results First Received: December 22, 2016
Last Updated: January 16, 2017