Clinical Trial Results:
A phase IIIb, open, multi-center study to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals’ MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals’ Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 and 4 years after MenACWY-TT booster vaccination.
Summary
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EudraCT number |
2012-002575-34 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
20 Apr 2016
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Results information
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Results version number |
v2(current) |
This version publication date |
30 Jan 2021
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First version publication date |
05 Nov 2016
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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 |
116727
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01777308 | ||
WHO universal trial number (UTN) |
- | ||
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 |
Interim
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Date of interim/final analysis |
11 Oct 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
03 Jul 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Apr 2016
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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 MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
*Vaccine response to meningococcal antigens (A, C, W-135 and Y) is defined as:
- For initially seronegative subjects (pre-vaccination rSBA titer below 1:8): rSBA antibody titer ≥ 1:32 one month after vaccination, and
- For initially seropositive subjects (pre-vaccination rSBA titer ≥ 1:8): at least four-fold increase in rSBA titers from pre-vaccination to one month after vaccination.
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Protection of trial subjects |
The axillary, rectal, oral or tympanic body temperature of all subjects needed to be measured prior to any study vaccine/product administration. The preferred route for recording temperature in this study was oral. If the subject had fever [fever was defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route] on the day of vaccination, the vaccination visit was rescheduled within the allowed interval for this visit.
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 for one month (minimum 30 days) following administration of vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 May 2013
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Efficacy | ||
Long term follow-up duration |
4 Years | ||
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 |
Australia: 156
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Worldwide total number of subjects |
156
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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) |
0
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Children (2-11 years) |
156
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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 |
- | |||||||||||||||||||||||||||
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. | |||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall study period (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Menitorix Group | |||||||||||||||||||||||||||
Arm description |
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Priorix™
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Investigational medicinal product code |
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Other name |
MMR
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects were primed with one dose of vaccine, administered subcutaneously on the upper-right side of the arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).
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Investigational medicinal product name |
Menitorix™
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Investigational medicinal product code |
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Other name |
Hib-MenC-TT
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were primed with one dose of vaccine, administered intramuscularly in the deltoid region of the left arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).
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Investigational medicinal product name |
GSK134612
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Investigational medicinal product code |
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Other name |
MenACWY-TT
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were boosted with one dose of vaccine, intramuscularly in the deltoid region of the left arm, at Month 72, post primary vaccination.
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Arm title
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Hiberix + Meningitec Group | |||||||||||||||||||||||||||
Arm description |
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | |||||||||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||||||||
Investigational medicinal product name |
Meningitec™
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Investigational medicinal product code |
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Other name |
MCC, MenC
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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 |
Subjects were primed with one dose of vaccine, intramuscularly in the deltoid region of the non-dominant arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).
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Investigational medicinal product name |
Hiberix™
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Investigational medicinal product code |
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Other name |
Hib
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were primed with one dose of vaccine, intramuscularly on the left side of the thigh, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).
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Investigational medicinal product name |
Priorix™
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Investigational medicinal product code |
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Other name |
MMR
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects were primed with one dose of vaccine, subcutaneously on the right-upper side of the arm, at 12-18 months of age, during the primary study HIB-MENC-TT-016 (NCT00326118).
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Investigational medicinal product name |
GSK134612
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Investigational medicinal product code |
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Other name |
MenACWY-TT
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Pharmaceutical forms |
Powder and solution for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects were boosted with one dose of vaccine, intramuscularly in the deltoid region of the left arm, at Month 72, post primary vaccination.
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Baseline characteristics reporting groups
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Reporting group title |
Menitorix Group
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Reporting group description |
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Hiberix + Meningitec Group
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Reporting group description |
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Menitorix Group
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Reporting group description |
Healthy male or female subjects, who were primed with Menitorix vaccine (administered intramuscularly in the deltoid region of the left arm) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. | ||
Reporting group title |
Hiberix + Meningitec Group
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Reporting group description |
Healthy male or female subjects, who were primed with Meningitec vaccine (administered intramuscularly in the deltoid region of the non-dominant arm), with Hiberix vaccine (administered intramuscularly in the left side of the thigh) and with Priorix vaccine (administered subcutaneously in the upper-right side of the arm) during the primary study HIB-MENC-TT-016 (NCT00326118), additionally received in the current study one booster dose of Nimenrix vaccine at Month 72 post-primary vaccination (Booster Visit 1). The Nimenrix vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
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End point title |
Number of subjects with vaccine response to the serum bactericidal assay meningococcal serogroup A, C, W-135 and Y using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) [1] | |||||||||||||||||||||
End point description |
Vaccine response was defined as :
- For initially seronegative subjects, antibody titer ≥ 1:32 at post-vaccination, and
- For initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
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End point type |
Primary
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End point timeframe |
At one month post booster vaccination (Month 73)
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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 scope of this primary end point was descriptive, 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-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers greater than or equal to (≥) the predefined cut-off values of 1:8 and 1:128 | |||||||||||||||||||||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At one month post booster vaccination (Month 73)
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No statistical analyses for this end point |
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End point title |
Anti-rSBA-MenA, anti-rSBA-MenC, anti-rSBA-MenW-135 and anti-rSBA-MenY antibody titers | ||||||||||||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
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End point type |
Secondary
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End point timeframe |
At one month post booster vaccination (Month 73)
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No statistical analyses for this end point |
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End point title |
Number of subjects with solicited local and solicited general symptoms | ||||||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever [defined as oral temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
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End point type |
Secondary
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End point timeframe |
During the 4 days (Day 0-3), post booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting new onset chronic illnesses (NOCIs) | ||||||||||||
End point description |
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
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End point type |
Secondary
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End point timeframe |
During the 31 days period (Day 0-30), post booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with unsolicited adverse events (AEs) | ||||||||||||
End point description |
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
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End point type |
Secondary
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End point timeframe |
During the 31 days period (Day 0-30), post booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with serious adverse events (SAEs) | ||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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End point type |
Secondary
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End point timeframe |
During the 31 days period (Day 0-30), post booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with SAEs | ||||||||||||
End point description |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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End point type |
Secondary
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End point timeframe |
From Month 72 until Data Lock Point (DLP) August 30th 2016
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values | |||||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
At Month 73, one month post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Antibody Concentrations Against Tetanus (Anti-T) Antigen | ||||||||||||
End point description |
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
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End point type |
Secondary
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End point timeframe |
At Month 73, one month post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values | |||||||||||||||||||||||||||||||||
End point description |
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
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End point type |
Secondary
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End point timeframe |
At Month 96, 24 months post-booster vaccination
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No statistical analyses for this end point |
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End point title |
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY | ||||||||||||||||||||||||
End point description |
Antibody titers were presented as geometric mean titers (GMTs).
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End point type |
Secondary
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End point timeframe |
At Month 96, 24 months post-booster vaccination
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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 local and solicited general symptoms: during the 4-day post-vaccination period; Solicited and unsolicited symptoms: during the 31-day post-vaccination period; SAEs: during the 31-day post-vaccination period and up to DLP.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Menitorix Group
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Reporting group description |
Healthy male or female subjects who were primed with Menitorix™ vaccine, administered intramuscularly in the deltoid region of the left arm, and Priorix™ vaccine, administered subcutaneously on the upper-right side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine, administered intramuscularly in the deltoid region of the left arm, at Month 72 post primary vaccination (booster visit 1) in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Hiberix + Meningitec Group
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Reporting group description |
Healthy male or female subjects who were primed with Meningitec™ vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, Hiberix™ vaccine, administered intramuscularly on the left side of the thigh, and Priorix™ vaccine, administered subcutaneously on the right-upper side of the arm, in the primary study HIB-MENC-TT-016 (106445), received one dose of GSK134612 booster vaccine at Month 72 post primary vaccination (booster visit 1) in the current study. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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26 Nov 2013 |
This protocol amendment has been done to remove the recording of any antipyretic administered in the period starting 6 hours before vaccination and ending 12 hours after vaccination in the protocol, since the collection of this information is not needed for the study, is not included in the eCRF and also involves a complex collection process.
In addition:
• Table 5 has been corrected with an error with respect to the allowed interval at Year 4.
• The authors list has been updated according to changes in the clinical study team.
• The Sponsor Information section now mentions that the Sponsor Information Sheet will be used instead of the local study contact information document for details of the Medical Expert and Study Monitor.
• The duration of the study of approximately four years for each subject has been mentioned for more clarity.
• The introduction has been updated with the current licensing status of GSK Biologicals’ MenACWY-TT conjugate vaccine.
• The recording of subjects’ non-participation in the booster study in the eCRF has been removed.
• The name of the HPA (Health Protection Agency) laboratory is now changed to PHE (Public Health England) laboratory.
• The manner in which the investigators will be provided with the immunogenicity results has been updated.
• The preparation of an annex report after the Year 2 persistence analysis has been removed since this analysis will be included in the Year 4 persistence CSR only. |
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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 |