Clinical Trial Results:
A Phase 3, observer blind, randomized, non-influenza vaccine comparator-controlled, multi-country and multi-centre study of the efficacy of GSK Biologicals’ quadrivalent, inactivated, split virion, seasonal influenza vaccine candidate, GSK2282512A (FLU Q-QIV), administered intramuscularly in healthy children 3 to 8 years of age
Summary
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EudraCT number |
2015-001514-97 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
09 Jan 2012
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Results information
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Results version number |
v2(current) |
This version publication date |
30 Jun 2022
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First version publication date |
09 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 |
114541
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01218308 | ||
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 |
Final
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Date of interim/final analysis |
31 May 2012
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 Jan 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jan 2012
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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 efficacy of Q-QIV in the prevention of reverse transcriptase polymerase chain reaction (RT-PCR) confirmed influenza A and or B disease presenting as influenza like illness (ILI), compared to a non-influenza vaccine comparator (Havrix) in children 3 to 8 years of age.
Influenza-like illness (ILI) was defined as the presence of an oral or axillary temperature ≥37.8° C in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion
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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 for one month (minimum 30 days) following administration of the last dose of study vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Dec 2010
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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 |
Bangladesh: 1000
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Country: Number of subjects enrolled |
Lebanon: 150
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Country: Number of subjects enrolled |
Turkey: 153
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Country: Number of subjects enrolled |
Dominican Republic: 1204
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Country: Number of subjects enrolled |
Honduras: 400
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Country: Number of subjects enrolled |
Panama: 204
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Country: Number of subjects enrolled |
Thailand: 1009
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Country: Number of subjects enrolled |
Philippines: 1100
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Worldwide total number of subjects |
5220
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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) |
5220
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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 |
A total of 5168 subjects have been enrolled in this study. Primed subjects had received at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine and had received 2 doses of seasonal influenza vaccine. Unprimed subjects had not received any influenza A (H1N1) 2009 monovalent vaccine or seasonal influenza vaccine. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
The duration of the study was approximately 4-8 weeks to complete enrolment, with at least six months extended safety follow-up (ESFU) after first vaccination, and lasted until the end of the influenza like illness (ILI) surveillance period. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||
Blinding implementation details |
Data was collected in an observer-blinded manner. Observer-blinded indicates that during the course of the study, the subjects (and their parents/LARs), the investigator, and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity, and immunogenicity) and review/analysis of study data were all unaware of the treatment assignments.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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FluLaval Quadrivalent Group | ||||||||||||||||||||||||||||||
Arm description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
FluLaval Quadrivalent
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Investigational medicinal product code |
GSK2282512A
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Other name |
Quadrivalent seasonal influenza vaccine GSK2282512A (FLU Q-QIV)
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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 |
One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.
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Arm title
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Havrix Group | ||||||||||||||||||||||||||||||
Arm description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix vaccine at Day 0 and, if unprimed, 2 doses of Havrix vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Havrix
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Investigational medicinal product code |
HAV Antigen
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Other name |
Havrix 720 Junior
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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 |
Two intramuscular doses (booster dose included) for primed subjects. Three intramuscular doses (booster dose included) for unprimed subjects. The booster dose was administered after the study was completed.
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 45 subjects from 1 center were excluded from the study due to GCP-related irregularities and the data (invalidated) from this center was not included in the subsequent data analysis of this study. Of the remaining 5175 subjects, 7 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered. |
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Baseline characteristics reporting groups
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Reporting group title |
FluLaval Quadrivalent Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Havrix Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix vaccine at Day 0 and, if unprimed, 2 doses of Havrix vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
FluLaval Quadrivalent Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | ||
Reporting group title |
Havrix Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix vaccine at Day 0 and, if unprimed, 2 doses of Havrix vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. |
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End point title |
Number of subjects reporting at least one confirmed occurrence of influenza A or B. [1] | |||||||||
End point description |
To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.
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End point type |
Primary
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End point timeframe |
From Day 14 to Day 180
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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 |
Number of subjects reporting at least one moderate to severe occurrence of influenza A or B. | |||||||||
End point description |
To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with: - Fever >39°C, and/or at least one of the following manifestations, - Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following, - Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis
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End point type |
Secondary
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End point timeframe |
From Day 14 to Day 180
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting at least one Culture Confirmed occurrence of influenza A or B due to antigenically matched strain. | |||||||||
End point description |
To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.
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End point type |
Secondary
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End point timeframe |
From Day 14 to Day 180
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No statistical analyses for this end point |
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End point title |
Number of subjects reporting at least one Culture Confirmed occurrence of influenza A or B due to any strain. | |||||||||
End point description |
To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.
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End point type |
Secondary
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End point timeframe |
From Day 14 to Day 180
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No statistical analyses for this end point |
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End point title |
Titers for serum Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease. | ||||||||||||||||||||||||||||||||||||
End point description |
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects against 4 strains of influenza disease. | |||||||||||||||||||||
End point description |
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects against 4 strains of influenza disease. | |||||||||||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
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No statistical analyses for this end point |
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End point title |
Seroconversion factor for Hemagglutination Inhibition (HI) antibodies against 4 strains of influenza disease. | ||||||||||||||||||||||||
End point description |
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]
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No statistical analyses for this end point |
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End point title |
Haemagglutination Inhibition (HI) antibody titers against each of the 4 vaccine strains | ||||||||||||||||||||||||||||||||||||
End point description |
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
On Day 0 and at least 6 months after first vaccination (Month 6)
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No statistical analyses for this end point |
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End point title |
Number of seroconverted subjects for HI antibody titers against each of the 4 vaccine influenza strains. | |||||||||||||||||||||
End point description |
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At least 6 months after first vaccination (Month 6)
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No statistical analyses for this end point |
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End point title |
Number of seroprotected subjects for HI antibody titers against each of the 4 vaccine influenza strains. | |||||||||||||||||||||||||||||||||
End point description |
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At Day 0 and at least 6 months after first vaccination (Month 6)
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No statistical analyses for this end point |
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End point title |
Seroconversion factors for HI antibodies against 4 strains of influenza disease. | ||||||||||||||||||||||||
End point description |
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).
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End point type |
Secondary
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End point timeframe |
At least 6 months after first vaccination (Month 6)
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No statistical analyses for this end point |
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End point title |
Number of subjects with any, grade 3 and related solicited local symptoms. | |||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = Incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful for subjects < 5 years of age or significant pain at rest that prevented normal, everyday activities for subjects ≥ 5 years of age. Grade 3 redness/swelling = Redness/swelling above 100 millimeters (mm) of the injection site. All solicited local symptoms were considered related to vaccination.
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End point type |
Secondary
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End point timeframe |
During the 7-day (Days 0-6) follow-up period after any vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with any, grade 3 and related solicited general symptoms in subjects below 5 years of age. | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade and relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = General symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.
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End point type |
Secondary
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End point timeframe |
During the 7-day (Days 0-6) follow-up period after any vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with any, grade 3 and related solicited general symptoms in subjects of 5 years of age and above. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (Gastro.), headache, joint pain at other location (Joint pain), muscle aches, shivering and temperature. Any = Occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Any temperature = Axillary temperature ≥ 38.0 °C. Grade 3 symptom = Symptom that prevented normal activity. Related = Symptom assessed by the investigator as causally related to the vaccination. Grade 3 temperature = Axillary temperature ≥ 39.0°C.
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End point type |
Secondary
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End point timeframe |
During the 7-day (Days 0-6) follow-up period after any vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs). | ||||||||||||||||||
End point description |
Unsolicited AE covers any AE 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 = Any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = Unsolicited AE that prevented normal activity. Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
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End point type |
Secondary
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End point timeframe |
During the 28-day (Days 0-27) follow-up period after vaccination
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No statistical analyses for this end point |
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End point title |
Number of subjects with any and related medically attended adverse events (MAEs). | |||||||||||||||
End point description |
MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = Any MAE regardless of intensity or relationship to vaccination. Related = MAE assessed by the investigator as causally related to the vaccination.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 - Day 180)
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No statistical analyses for this end point |
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End point title |
Number of subjects with any and related potential immune-mediated diseases (pIMDs). | |||||||||||||||
End point description |
pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any = Any pIMD(s) regardless of intensity or relationship to vaccination. Related = pIMDs assessed by the investigator as causally related to the vaccination.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 - Day 180)
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No statistical analyses for this end point |
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End point title |
Number of subjects with any and related serious adverse events (SAEs). | |||||||||||||||
End point description |
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Any SAE(s) regardless of intensity or relationship to vaccination. Related = SAEs assessed by the investigator as causally related to the vaccination.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 - Day 180)
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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 |
SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination.
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Adverse event reporting additional description |
For the systematically assessed other non-serious AEs, the number of participants at risk included those from Total Vaccinated cohort whose symptom sheet had been completed.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Havrix Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix vaccine at Day 0 and, if unprimed, 2 doses of Havrix vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
FluLaval Quadrivalent Group
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Reporting group description |
Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively). |
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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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15 Jun 2011 |
The overall rationale for this amendment is two-fold. First, the protocol is being amended to implement changes to the protocol of the study’s first year (in progress). Second, the amendment also facilitates the use of the protocol for a potential extension of the study to a second year, based on the outcome of a benefit interim analysis planned for the end of the first year. |
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28 Jul 2011 |
The original protocol indicated that the study would conclude at the end of the extended safety follow-up (ESFU) visit. This amended protocol recommends that wherever possible, the ESFU visit (provided it occurs at least six months after the first vaccination) should be scheduled to coincide with the end of the ILI surveillance period so that it will not be necessary to have a separate final contact with subjects at the end of ILI surveillance.
However, in the event that subjects in a particular country complete the ESFU visit prior to the end of the ILI surveillance period, this amendment to the protocol adds a final phone contact at the end of the ILI surveillance period to conclude the study. This final phone contact will enable the collection of essential subject data from the subjects for whom the ILI surveillance continues after the ESFU visit and the phone contact will also enable study conclusion for these 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 |