Clinical Trial Results:
A phase III, randomized, single-blind, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course at 6, 10 and 14 weeks of age in India, co-administered with GSK Biologicals’ Tritanrix-HepB/Hib (DTPw-HBV/Hib) vaccine.
Summary
|
|
EudraCT number |
2011-004644-22 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Nov 2009
|
Results information
|
|
Results version number |
v2(current) |
This version publication date |
26 Oct 2022
|
First version publication date |
23 Jul 2015
|
Other versions |
v1 |
Version creation reason |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
Trial identification
|
|||
Sponsor protocol code |
111188
|
||
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT00814710 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
|
|||
Sponsor organisation name |
GlaxoSmithKline Biologicals
|
||
Sponsor organisation address |
Rue de l’Institut 89, Rixensart, Belgium, B-1330
|
||
Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
|
||
Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
|
||
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
|
||
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
13 Apr 2010
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
13 Nov 2009
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
13 Nov 2009
|
||
Was the trial ended prematurely? |
No
|
||
General information about the trial
|
|||
Main objective of the trial |
To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in India, one month post dose 3.
|
||
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.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Mar 2009
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
India: 360
|
||
Worldwide total number of subjects |
360
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
360
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
|
|||||||||||||||||||
Recruitment
|
|||||||||||||||||||
Recruitment details |
- | ||||||||||||||||||
Pre-assignment
|
|||||||||||||||||||
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
|
|||||||||||||||||||
Period 1 title |
Overall Study (overall period)
|
||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||
Blinding used |
Single blind | ||||||||||||||||||
Roles blinded |
Subject | ||||||||||||||||||
Blinding implementation details |
This study was conducted in a single-blind manner meaning that the investigator and the study staff are aware of the treatment assignment but the subject’s parent(s)/guardian(s) are not.
|
||||||||||||||||||
Arms
|
|||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||
Arm title
|
Synflorix & Tritanrix-HepB/Hib Group | ||||||||||||||||||
Arm description |
Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with Tritanrix-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Pneumococcal conjugate vaccine GSK1024850A
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
10Pn-PD-DiT
|
||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the right thigh
|
||||||||||||||||||
Investigational medicinal product name |
Tritanrix-HepB/Hib
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
DTPw-HBV/Hib
|
||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the left thigh
|
||||||||||||||||||
Arm title
|
Hiberix group & Tritanrix-HepB Group | ||||||||||||||||||
Arm description |
Subjects received Hiberix intramuscularly in the right thigh co-administered with Tritanrix-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2). | ||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||
Investigational medicinal product name |
Hiberix
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
Hib
|
||||||||||||||||||
Pharmaceutical forms |
Powder and solvent for solution for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the right thigh
|
||||||||||||||||||
Investigational medicinal product name |
Tritanrix-HepB
|
||||||||||||||||||
Investigational medicinal product code |
|||||||||||||||||||
Other name |
DTPw-HBV
|
||||||||||||||||||
Pharmaceutical forms |
Suspension for injection
|
||||||||||||||||||
Routes of administration |
Intramuscular use
|
||||||||||||||||||
Dosage and administration details |
3 doses at 6-10-14 weeks of age (=study month 0, 1, 2) administered in the left thigh
|
||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Baseline characteristics reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Synflorix & Tritanrix-HepB/Hib Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with Tritanrix-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Hiberix group & Tritanrix-HepB Group
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received Hiberix intramuscularly in the right thigh co-administered with Tritanrix-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
End points reporting groups
|
|||
Reporting group title |
Synflorix & Tritanrix-HepB/Hib Group
|
||
Reporting group description |
Subjects received Pneumococcal conjugate vaccine GSK1024850A intramuscularly in the right thigh co-administered with Tritanrix-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) | ||
Reporting group title |
Hiberix group & Tritanrix-HepB Group
|
||
Reporting group description |
Subjects received Hiberix intramuscularly in the right thigh co-administered with Tritanrix-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2). |
|
|||||||||||||||||||||||||||||||||||||||||||
End point title |
Concentrations of antibodies against vaccine pneumococcal serotypes [1] | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F).
|
||||||||||||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Concentration of antibody against protein D (PD) [2] | |||||||||||||||
End point description |
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL).
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||
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. |
||||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with opsonophagocytic activity against pneumococcal serotypes | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay was an opsonic titer equal to or greater than 8.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with antibody concentrations against pneumococcal serotypes equal to or above cut-off value | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. The cut-off was defined as 0.20 microgram per milliliter (µg/mL).
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after primary immunization.
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Concentrations of antibodies against pneumococcal cross-reactive serotypes | ||||||||||||||||||
End point description |
Concentrations were expressed as GMCs in μg/mL. Pneumococcal cross-reactive serotypes included 6A and 19A.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects seropositive for pneumococcal serotypes | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3)
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects seropositive for protein D (PD) | ||||||||||||
End point description |
Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Concentration of antibody against polyribosyl-ribitol phosphate (PRP) | |||||||||||||||
End point description |
Concentration is expressed as GMC in µg/mL.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
End point title |
Concentration of antibodies against diphteria (anti-DT) and tetanus (anti-TT) | ||||||||||||||||||
End point description |
Concentrations were expressed as GMCs in International Units per milliliter (IU/mL).
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||||||||
|
|||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Concentration of antibody against Bordetella pertussis (BPT) | |||||||||||||||
End point description |
Concentration was expressed as GMC in EL.U/mL.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Concentration of antibody against hepatitis B (anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA) | |||||||||||||||
End point description |
Concentration was expressed as GMC in milli international units per milliliter (mIU/mL). As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table shows results following partial or complete retesting/reanalysis.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects seropostive for B. pertussis (BPT) | ||||||||||||
End point description |
Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||
End point title |
Number of seroprotected subjects (anti-DT, anti-TT, anti-PRP, anti-HBs) | |||||||||||||||||||||
End point description |
Seroprotection was defined as: Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL.
|
|||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
|||||||||||||||||||||
|
||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of seroprotected subjects (anti-PRP above the cut-off of 1.0 µg/mL). | ||||||||||||
End point description |
Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
One month after primary immunization (month 3).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with solicited local symptoms (any and grade 3) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited local symptoms included pain, redness and swelling. Any = Occurrence of the local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = at injection site larger than (>) 30 millimeters (mm).
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 4 days (day 0-3) after each vaccination
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with unsolicited adverse events (AEs) | ||||||||||||
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. 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within 31 days (day 0-30) after vaccination.
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Following first vaccination (Month 0) throughout the entire study period (month 3).
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point title |
Number/percentage of subjects with any and grade 3 solicited general symptoms | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 and > 39.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal everyday activities. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal everyday activities. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>)40.0°C.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Within 4 days (day 0-3) after each vaccination
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
For other AEs day 0-3 (solicited) and day 0-30 unsolicited. For SAEs month 0 to Month 3.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Synflorix and Tritanrix-HepB/Hib Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received Synflorix (GSK1024850A) intramuscularly in the right thigh co-administered with Tritanrix-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2). | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Hiberix group and Tritanrix-HepB Group
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received Hiberix intramuscularly in the right thigh co-administered with Tritanrix-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. [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 of the solicited symptom included only subjects with documented data. |
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |