Clinical Trial Results:
A phase III, single group, open study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in Taiwan when co-administered with GSK Biologicals’ Infanrix hexa (DTPa-HBV-IPV/Hib) vaccine as a 3-dose primary immunization course at 1.5; 3 and 6 months of age and GSK Biologicals’ Rotarix vaccine (HRV) as a 2-dose primary immunization course at 1.5 and 3 months of age.
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Summary
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EudraCT number |
2015-001511-12 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
06 Jun 2008
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Results information
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Results version number |
v2(current) |
This version publication date |
09 Apr 2021
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First version publication date |
29 Jul 2015
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
109861
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00533507 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Oct 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Jun 2008
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in Taiwan, one month post dose 3, when co-administered with GSK Biologicals’ Infanrix hexa and GSK Biologicals’ Rotarix vaccines
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Sep 2007
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Taiwan: 230
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Worldwide total number of subjects |
230
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
230
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
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Pre-assignment
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Screening details |
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. | ||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Synflorix group | ||||||||||
Arm description |
Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age. | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
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Other name |
10Pn-PD-DiT, Pneumococcal conjugate vaccine GSK1024850A
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine was injected intramuscularly in the right thigh at 1.5, 3 and 6 months of age.
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Investigational medicinal product name |
Infanrix hexa
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Investigational medicinal product code |
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Other name |
DTPa-HBV-IPV/Hib
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Pharmaceutical forms |
Powder and suspension for suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The vaccine was injected intramuscularly in the left thigh, at 1.5, 3 and 6 months of age.
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Investigational medicinal product name |
Rotarix
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Investigational medicinal product code |
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Other name |
HRV vaccine
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Pharmaceutical forms |
Powder and solvent for oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
The vaccine was administered orally at 1.5 and 3 months of age.
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Baseline characteristics reporting groups
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Reporting group title |
Synflorix group
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Reporting group description |
Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Synflorix group
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Reporting group description |
Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age. | ||
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End point title |
Concentration of Anti-Protein D Antibodies [1] | ||||||||||
End point description |
Concentrations are given as geometric mean concentrations (GMC) and expressed in Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
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End point type |
Primary
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End point timeframe |
One month after the third dose
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||
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End point title |
Concentration of Anti-Pneumococcal Antibodies [2] | ||||||||||||||||||||||||||||
End point description |
Concentrations are given as geometric mean titers (GMC) and expressed in microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
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End point type |
Primary
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End point timeframe |
One month after the third dose
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Anti-Protein D Antibody Concentrations Above the Cut-Off Value | ||||||||||
End point description |
Anti-protein D antibody cut-off value assessed was greater than or equal to 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
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End point type |
Secondary
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End point timeframe |
Before the first dose (pre) and one month after (post) the third dose
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | ||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
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End point type |
Secondary
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End point timeframe |
Before the first dose (pre) and one month after (post) the third dose
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value | ||||||||||
End point description |
Number of Subjects With Cross-Reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-Off Value
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-Off Value | ||||||||||||||||||||||||||
End point description |
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Number of Subjects With Opsonophagocytic Activity Against Cross-Reactive Pneumococcal Serotypes Above the Cut-Off Value | ||||||||||
End point description |
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was greater than or equal to 1:8 titer.
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With Anti-Polyribosyl-Ribitol Phosphate Antibody Concentrations Above the Cut-Off Value | ||||||||
End point description |
Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was greater than or equal to 0.15 microgram per milliliter (μg/mL).
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Anti-Diphteria and Anti-Tetanus Toxoids Antibody Concentrations Above the Cut-Off Value | ||||||||||
End point description |
Anti-diphteria and anti-tetanus toxoids antibody cut-off values assessed were greater than or equal to 0.10 International Units per milliliter (IU/mL).
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||
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End point title |
Number of Subjects With Anti-Pertussis (PT), Anti-Filamentous Hemagglutinin (FHA) and Anti-Pertactin (PRN) Antibody Concentrations Above the Cut-Off Value | ||||||||||||
End point description |
Anti-PT, anti-FHA and anti-PRN cut-off values assessed were greater than or equal to 5 Enzyme-Linked Immuno Sorbent Assay (ELISA) units per milliliter (EL.U/mL).
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Anti-Hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-Off Value | ||||||||
End point description |
Anti-HBs antibody cut-off value assessed was greater than or equal to 10 milli-International Units per milliliter (mIU/mL).
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Anti-Poliovirus 1, 2 and 3 Antibody Titers Above the Cut-Off Value | ||||||||||||
End point description |
Anti-poliovirus 1, 2 and 3 antibody cut-off value assessed was greater than or equal to 1:8 titer.
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End point type |
Secondary
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End point timeframe |
One month after the third dose
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Subjects With Anti-rotavirus Immunoglobulin A antibody concentrations Above the Cut-Off Value | ||||||||
End point description |
Anti-rotavirus IgA antibody cut-off value assessed was greater than or equal to 20 Units per milliliter (U/mL).
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End point type |
Secondary
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End point timeframe |
Four months after the administration of the second dose of Rotarix™ vaccine
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting solicited local symptoms | ||||||||||||
End point description |
Solicited local symptoms assessed include pain, redness and swelling.
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 0-3) period after any dose
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of subjects reporting unsolicited adverse events (AE) | ||||||||
End point description |
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
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End point type |
Secondary
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End point timeframe |
During the 31-day (Day 0-30) period after each dose
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects reporting serious adverse events (SAE) | ||||||||
End point description |
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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End point type |
Secondary
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End point timeframe |
Up to one month after the third dose
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of subjects with solicited general symptoms | ||||||||||||||||||
End point description |
Solicited general symptoms assessed include diarrhoea, drowsiness, fever, irritability, loss of appetite, and vomiting
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End point type |
Secondary
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End point timeframe |
During the 4-day (Day 0-3) period after any dose
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| No statistical analyses for this end point | |||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Solicited symptoms: during the 4 days (Day 0-Day 3) following vaccination.
Unsolicited AEs: during the 31 days (Day 0-Day 30) following vaccination.
SAEs: during the entire study.
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Adverse event reporting additional description |
The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
11.0
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Reporting groups
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Reporting group title |
Synflorix Group
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Reporting group description |
Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 Nov 2007 |
This amendment is made following the request from the country to perform immunogenicity analyses of the co-administered vaccines in a subset of subjects. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
