Clinical Trial Results:
A phase III, randomized, open, 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 Sub-Saharan Africa, co-administered with GSK Biologicals’ DTPw-HBV/Hib and OPV vaccines.
Summary
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EudraCT number |
2011-004650-25 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
10 Dec 2009
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Results information
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Results version number |
v3(current) |
This version publication date |
22 Jul 2022
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First version publication date |
05 Jul 2015
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Other versions |
v1 (removed from public view) , v2 |
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 |
110521
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00678301 | ||
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 |
13 Oct 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Dec 2009
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in infants in Sub-Saharan Africa, one month post dose 3.
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Protection of trial subjects |
All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines. Subjects were followed up from the time the subject consented to participate in the study through consent by his/her parents/guardians until she/he was discharged.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
18 Jun 2008
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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 |
Nigeria: 127
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Country: Number of subjects enrolled |
Mali: 238
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Worldwide total number of subjects |
365
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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) |
365
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
At screening, the following steps occurred: check for inclusion/exclusion criteria, contraindications/ precautions, medical and vaccination history of the subjects and signing or thumb-printing informed consent forms. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Among 365 enrolled subjects, 8 were not administered any study vaccine and hence were not considered as starting the study. | ||||||||||||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
365 | ||||||||||||||||||||||||
Number of subjects completed |
357 | ||||||||||||||||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Subject not vaccinated: 8 | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||
Allocation method |
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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Synflorix + Zilbrix Hib + Polio Sabin | ||||||||||||||||||||||||
Arm description |
Subjects in this group received 3 doses of Synflorix vaccine according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to the same schedule. The Synflorix and Zilbrix Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin vaccine was administered orally. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Synflorix
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Investigational medicinal product code |
10Pn-PD-DiT
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Other name |
10Pn, 10Pn-PD-DiT, GSK1024850A
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
The Synflorix vaccine was administered by intramuscular injection, in the right thigh, according to a 3-dose schedule at 6-10-14 weeks of age.
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Investigational medicinal product name |
Polio Sabin
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Investigational medicinal product code |
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Other name |
OPV (Oral polio vaccine)
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
The Polio Sabin vaccine was administered orally, according to a 3-dose schedule at 6-10-14 weeks of age.
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Investigational medicinal product name |
Zilbrix Hib
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Investigational medicinal product code |
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Other name |
DTPw-HBV/Hib (Diphtheria-tetanus-whole cell pertussis-hepatitis B/ Haemophilus influenzae type b vaccine)
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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 |
The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh, according to a 3-dose schedule at 6-10-14 weeks of age.
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Arm title
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Zilbrix Hib + Polio Sabin | ||||||||||||||||||||||||
Arm description |
Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin vaccine was administered orally. | ||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||
Investigational medicinal product name |
Polio Sabin
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Investigational medicinal product code |
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Other name |
OPV
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
The Polio Sabin vaccine was administered orally, according to a 3-dose schedule at 6-10-14 weeks of age.
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Investigational medicinal product name |
Zilbrix Hib
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Investigational medicinal product code |
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Other name |
DTPw-HBV/Hib
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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 |
The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh, according to a 3-dose schedule at 6-10-14 weeks of age.
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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: Among 365 enrolled participants, 8 were not administered any study vaccine and hence were not considered as starting the study. |
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Baseline characteristics reporting groups
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Reporting group title |
Synflorix + Zilbrix Hib + Polio Sabin
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Reporting group description |
Subjects in this group received 3 doses of Synflorix vaccine according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to the same schedule. The Synflorix and Zilbrix Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Zilbrix Hib + Polio Sabin
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Reporting group description |
Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin vaccine was administered orally. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Synflorix + Zilbrix Hib + Polio Sabin
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Reporting group description |
Subjects in this group received 3 doses of Synflorix vaccine according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to the same schedule. The Synflorix and Zilbrix Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin vaccine was administered orally. | ||
Reporting group title |
Zilbrix Hib + Polio Sabin
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Reporting group description |
Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin vaccine was administered orally. |
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End point title |
Concentrations of antibodies against vaccine pneumococcal serotypes [1] | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations greater than or equal to (>=) 0.05 microgram per milliliter (µg/mL).
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End point type |
Primary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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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 |
Antibody concentrations against protein D (anti-PD antibodies) [2] | |||||||||||||||
End point description |
Anti-PD antibody concentrations were expressed in enzyme-linked immunorbent assay (ELISA) units per millilitre (EL.U/mL). Seropositivity cut-off for the assay was an anti-PD antibody concentrations >= 100 EL.U/mL.
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End point type |
Primary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Concentrations of antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A) | ||||||||||||||||||
End point description |
Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) >= 0.05 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Titers for opsonophagocytic activity (OPA) against vaccine pneumococcal serotypes | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) >= 8.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Titers for opsonophagocytic activity (OPA) against cross-reactive pneumococcal serotypes | ||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) >= 8.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for antibodies against vaccine pneumococcal serotypes | |||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations >= 0.05 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seroprotected against vaccine pneumococcal serotypes | |||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seroprotection cut-off for the assay was an anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) concentrations >= 0.2 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for antibodies against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A) | |||||||||||||||
End point description |
Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as anti-pneumococcal cross-reactive serotypes 6A/19A antibody concentrations (Anti-6A/19A) >= 0.05 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seroprotected against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A and -19A) | |||||||||||||||
End point description |
Serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seroprotection cut-off for the assay was an anti-6A/19A antibody concentrations >= 0.2 microgram per milliliter (µg/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for antibodies against protein D (Anti-PD antibodies) | ||||||||||||
End point description |
Seropositivity cut-off for the assay was an anti-PD antibody concentrations >= 100 EL.U/mL.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for opsonophagocytic activity against vaccine pneumococcal serotypes | |||||||||||||||||||||||||||||||||||||||
End point description |
Pneumococcal serotypes assessed were vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Seropositivity status was defined as an opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) >= 8.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for opsonophagocytic activity against cross-reactive pneumococcal serotypes | |||||||||||||||
End point description |
Pneumococcal serotypes assessed were cross-reactive pneumococcal serotypes 6A and 19A. Seropositivity status was defined as an opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A (OPA-6A and 19A) >= 8.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Synflorix vaccine
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No statistical analyses for this end point |
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End point title |
Anti-Bordetella pertussis (anti-BPT) antibody concentrations | |||||||||||||||
End point description |
Anti-BPT antibody concentrationswere expressed in enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL). Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentrations >= 15 EL.U/mL.
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seropositive for antibodies against Bordetella pertussis (anti-BPT) | ||||||||||||
End point description |
Seropositivity cut-off for the assay was defined as an anti-BPT antibody concentration >= 15 enzyme-linked immunosorbent assay (ELISA) unit per millilitre (EL.U/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
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No statistical analyses for this end point |
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End point title |
Anti-diphtheria (Anti-D) and anti-tetanus toxoids (Anti-TT) antibody concentrations | ||||||||||||||||||
End point description |
The seroprotection cut-off for the endpoint was an anti-diphtheria toxoid or anti-tetanus toxoid antibody concentrations >= 0.1 international unit per millliter (IU/mL).
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End point type |
Secondary
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End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
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No statistical analyses for this end point |
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End point title |
Number of subjects seroprotected against diphtheria (D) and tetanus toxoids (TT) antigens | |||||||||||||||
End point description |
A subject seroprotected against D/TT antigens was defined as a subject with an Anti-D/-TT antibody concentration >= 0.1 international unit per millliter (IU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-polyribosyl-ribitol-phosphate (Anti-PRP) antibody concentrations | |||||||||||||||
End point description |
Anti-PRP antibody concentrations were measured and tabulated in microgram per millilitre (µg/mL). Cut-off for the assay was >= 0.15 µg/mL.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects seroprotected against polyribosyl-ribitol phosphate (PRP) | ||||||||||||
End point description |
Anti-PRP antibody concentrations were expressed in microgram per millilitre (µg/mL). The seroprotection cut-off applied for the assay was >= 0.15 µg/mL.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects seroprotected against polyribosyl-ribitol phosphate (PRP) antigens | ||||||||||||
End point description |
Anti-PRP antibody concentrations were expressed in microgram per millilitre (µg/mL). The seroprotection cut-off applied for the assay was >= 1 µg/mL.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Anti-hepatitis B surface antigen (HBs) antibody concentrations | |||||||||||||||
End point description |
The seroprotection cut-off for the endpoint was an an anti-HBs antibody concentration >= 10 milli-international units per millliter (mIU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Number of subjects seroprotected against anti-Hepatitis B surface antigens (HBs) | |||||||||||||||
End point description |
The seroprotection cut-off values considered for this endpoint were an anti-HBs antibody concentration >= 10 and 100 milli-international units per millliter (mIU/mL).
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
At Month 3, one month after the administration of the third dose of Tritanrix -HepB/ Hiberix vaccine
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Number of subjects with any and any Grade 3 solicited local symptoms | |||||||||||||||||||||||||||
End point description |
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness greater than (>) 30 millimeters (mm). “Any” was defined as incidence of the specified symptom regardless of intensity.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||
End point title |
Number of subjects with any and any Grade 3 and related solicited general symptoms | |||||||||||||||||||||||||||||||||
End point description |
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature >= 38.0°C), irritability, and loss of appetite. “Any” was defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) greater than (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all.
|
|||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||
End point timeframe |
Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
|
|||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with fever (temperature measured rectally) > the cut-off | ||||||||||||
End point description |
The cut-off for the assay was > 39.0°C.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within the 4-day (Days 0 to 3) follow-up periods after each vaccination, across doses and across vaccines
|
||||||||||||
|
|||||||||||||
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. “Any” was defined as incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Within the 31-day (Days 0-30) follow-up periods post vaccination, across doses and across vaccines
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Number of subjects with 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Throughout the entire study period, from Month 0 to Month 3
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
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Timeframe for reporting adverse events |
Solicited symptoms and unsolicited AEs: During the 4-day (Days 0-3) and 31-day (Days 0-30) post vaccination follow-up periods, respectively, across doses and across vaccines. SAEs: throughout the entire study period, from Month 0 to Month 3.
|
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
12.0
|
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Reporting groups
|
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Reporting group title |
Synflorix + Zilbrix Hib + Polio Sabin
|
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Reporting group description |
Subjects in this group received 3 doses of Synflorix vaccine, according to a 3-dose schedule at 6-10-14 weeks of age co-administered with 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to the same schedule. The Synflorix and Zilbrix Hib vaccines were administered by intramuscular injection, in the right and left thigh respectively. The Polio Sabin vaccine was administered orally. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Zilbrix Hib + Polio Sabin
|
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Reporting group description |
Subjects in this group received 3 doses of Expanded Program on Immunization (EPI) vaccines Zilbrix Hib and Polio Sabin according to a 3-dose schedule at 6-10-14 weeks of age. The Zilbrix Hib vaccine was administered by intramuscular injection, in the left thigh. The Polio Sabin vaccine was administered orally. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
19 Feb 2008 |
Amendment 1 was made in response to comments of the Ethics Committee of Mali and included the following changes: 1) Data and related publications on invasive pneumococcal disease in Mali were included; 2) Update on the presentation and administration of the OPV vaccine (Polio Sabin); 3) Update in the statistical analysis of safety; 4) Clarification on recording in the clinical report form (CRF) of administered vaccines other than the study vaccines; 5) Correction in the reference to the standard operating procedure (SOP) on destruction of used/unused vaccine vials/syringes/containers. |
||
17 Mar 2009 |
Amendment 2 was made to include the following changes: 1) Planning of an interim analysis on all cleaned demographic, reactogenicity and immunogenicity data pertaining to Malian subjects enrolled by 31 December 2008; 2) Change in coordinating author and contributing authors. |
||
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 |