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Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria

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ClinicalTrials.gov Identifier: NCT01153893
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : March 15, 2012
Last Update Posted : September 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Streptococcal
Interventions Biological: Pneumococcal vaccine GSK1024850A
Biological: InfanrixTM
Enrollment 105

Recruitment Details The duration of the study depends on the group allocation. The duration of the study per subject can vary from 1 month (Synflorix/Infanrix primed Group) to 3 months (Synflorix/Infanrix unprimed Group).
Pre-assignment Details Because of an issue with the informed consent of a child, the data of the child, who had a non-related to study medication serious adverse event, are not detailed in this analysis. Data were reanalyzed for the 104 subjects with data available.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Period Title: Overall Study
Started 68 [1] 36
Completed 67 [2] 36 [3]
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
[1]
Issues with the informed consent obtained from one child led to related data not used in this report
[2]
Number of subjects who completed the follow-up visit at Month 1.
[3]
Number of subjects who completed the follow-up visit at Month 3.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group Total
Hide Arm/Group Description Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. Total of all reporting groups
Overall Number of Baseline Participants 68 36 104
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 68 participants 36 participants 104 participants
16.7  (1.00) 16.4  (0.91) 16.55  (0.955)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 36 participants 104 participants
Female
29
  42.6%
17
  47.2%
46
  44.2%
Male
39
  57.4%
19
  52.8%
58
  55.8%
1.Primary Outcome
Title Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited).
Hide Description

Grade 3 symptom = severe symptom that prevented normal activity.

Solicited local symptoms assessed were pain, redness and swelling.

Solicited general symptoms assessed were drowsiness, fever, irritability and loss of appetite.

Unsolicited AEs = Any AE reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Time Frame Within 31 days (Day 0 to Day 30) after administration of a booster dose of Synflorix vaccine in the Synflorix/Infanrix primed Group.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 0
Measure Type: Count of Participants
Unit of Measure: Participants
Any symptom
3
   4.4%
General symptoms
1
   1.5%
Local symptoms
2
   2.9%
2.Secondary Outcome
Title Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Hide Description

Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).

Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.

Time Frame Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-1 [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.29
(0.22 to 0.40)
0.03
(0.03 to 0.04)
Anti-1 [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
8.72
(6.37 to 11.93)
3.17
(2.58 to 3.89)
Anti-4 [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.40
(0.31 to 0.50)
0.06
(0.04 to 0.09)
Anti-4 [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
11.03
(9.06 to 13.42)
8.22
(6.75 to 10.02)
Anti-5 [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.49
(0.40 to 0.61)
0.05
(0.04 to 0.07)
Anti-5 [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
10.34
(8.32 to 12.85)
2.87
(2.22 to 3.71)
Anti-6B [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.63
(0.48 to 0.83)
0.05
(0.03 to 0.08)
Anti-6B [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
4.31
(3.37 to 5.52)
0.85
(0.52 to 1.38)
Anti-7F [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.73
(0.57 to 0.92)
0.05
(0.04 to 0.08)
Anti-7F [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
10.30
(8.57 to 12.38)
6.07
(4.89 to 7.52)
Anti-9V [pre-booster;pre-vacc] Number Analyzed 67 participants 35 participants
1.04
(0.78 to 1.39)
0.06
(0.04 to 0.10)
Anti-9V [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
11.49
(9.02 to 14.65)
2.70
(2.05 to 3.55)
Anti-14 [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
1.13
(0.87 to 1.46)
0.14
(0.08 to 0.23)
Anti-14 [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
14.14
(11.74 to 17.04)
10.59
(8.70 to 12.89)
Anti-18C [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
1.62
(1.30 to 2.04)
0.05
(0.03 to 0.09)
Anti-18C [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
35.33
(27.73 to 45.02)
25.61
(19.70 to 33.30)
Anti-19F [pre-booster;pre-vacc] Number Analyzed 67 participants 35 participants
1.20
(0.85 to 1.71)
0.14
(0.08 to 0.24)
Anti-19F [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
9.26
(7.20 to 11.91)
7.16
(4.27 to 12.02)
Anti-23F [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.46
(0.32 to 0.68)
0.03
(0.02 to 0.04)
Anti-23F [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
6.99
(5.21 to 9.39)
1.06
(0.66 to 1.70)
3.Secondary Outcome
Title Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Hide Description

Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).

The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.

Time Frame Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-6A [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.19
(0.13 to 0.27)
0.05
(0.03 to 0.07)
Anti-6A [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
0.81
(0.56 to 1.18)
0.24
(0.15 to 0.40)
Anti-19A [pre-booster;pre-vacc] Number Analyzed 68 participants 35 participants
0.24
(0.17 to 0.36)
0.09
(0.05 to 0.17)
Anti-19A [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
1.33
(0.88 to 2.00)
1.94
(1.13 to 3.33)
4.Secondary Outcome
Title Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
Hide Description

Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8.

Time Frame One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 67 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
Opsono-1 [post-booster;post-dose 2] Number Analyzed 66 participants 35 participants
1667.8
(1210.9 to 2297.0)
103.4
(67.7 to 157.9)
Opsono-4 [post-booster;post-dose 2] Number Analyzed 65 participants 35 participants
3869.1
(3122.8 to 4793.9)
1482.9
(1211.0 to 1815.8)
Opsono-5 [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
679.9
(515.9 to 895.9)
58.7
(38.6 to 89.4)
Opsono-6B [post-booster;post-dose 2] Number Analyzed 66 participants 31 participants
1687.6
(1138.7 to 2501.0)
325.7
(118.1 to 898.6)
Opsono-7F [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
11045.3
(8456.8 to 14426.3)
7980.2
(6287.8 to 10128.1)
Opsono-9V [post-booster;post-dose 2] Number Analyzed 66 participants 35 participants
5300.1
(4329.3 to 6488.5)
6375.3
(4779.4 to 8504.1)
Opsono-14 [post-booster;post-dose 2] Number Analyzed 66 participants 35 participants
2472.0
(1767.3 to 3457.8)
1797.8
(1241.4 to 2603.6)
Opsono-18C [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
2323.0
(1403.1 to 3846.1)
4104.2
(2954.5 to 5701.2)
Opsono-19F [post-booster;post-dose 2] Number Analyzed 65 participants 34 participants
683.5
(440.0 to 1062.0)
443.5
(203.0 to 968.8)
Opsono-23F [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
5144.5
(3657.4 to 7236.3)
3081.7
(1389.3 to 6836.1)
5.Secondary Outcome
Title Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes.
Hide Description

Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A.

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results were presented as the dilution of serum (opsonic titre) able to sustain 50% killing of live pneumococci under the assay conditions. The cut-off of the assay is an opsonic titre of 8.

Time Frame One month after the booster immunisation for the Synflorix/Infanrix primed Group and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 66 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
Opsono-6A [post-booster;post-dose 2] Number Analyzed 61 participants 34 participants
213.0
(121.7 to 372.9)
313.9
(147.6 to 667.4)
Opsono-19A [post-booster;post-dose 2] Number Analyzed 66 participants 35 participants
112.7
(66.7 to 190.5)
341.2
(159.0 to 732.1)
6.Secondary Outcome
Title Concentration of Antibodies Against Protein D (PD).
Hide Description Anti-PD antibodies were determined using an ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EL.U/mL).
Time Frame Prior to and one month after the booster immunisation for the Synflorix/Infanrix primed Group and prior to the first dose and one month after Dose 2 in the Synflorix/Infanrix unprimed Group
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom immunogenicity data were available. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D for the blood sample taken one month after vaccination.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 67 35
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD [pre-booster;pre-vacc] Number Analyzed 66 participants 35 participants
270.4
(211.7 to 345.3)
61.5
(52.0 to 72.7)
Anti-PD [post-booster;post-dose 2] Number Analyzed 67 participants 35 participants
2955.3
(2342.0 to 3729.2)
501.1
(345.0 to 727.9)
7.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local AEs.
Hide Description

Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events was actively solicited from the subject or an observer during a specified post-vaccination follow-up period.

Solicited local symptoms assessed were pain, redness and swelling.

Any = occurrence of any local symptom regardless of intensity grade.

Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm)

Time Frame Within 4 days (Days 0-3) after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 36
Measure Type: Count of Participants
Unit of Measure: Participants
Any pain
27
  39.7%
13
  36.1%
Grade 3 pain
0
   0.0%
0
   0.0%
Any redness
1
   1.5%
1
   2.8%
Redness > 30 mm
0
   0.0%
1
   2.8%
Any swelling
4
   5.9%
2
   5.6%
Swelling > 30 mm
2
   2.9%
1
   2.8%
8.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs.
Hide Description

Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).

Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.

Related = solicited symptom assessed by the investigator as causally related to study vaccination.

Time Frame Within 4 days (Days 0-3) after vaccination.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 36
Measure Type: Count of Participants
Unit of Measure: Participants
Any drowsiness
2
   2.9%
0
   0.0%
Grade 3 drowsiness
0
   0.0%
0
   0.0%
Related drowsiness
2
   2.9%
0
   0.0%
Fever >= 37.5°C
8
  11.8%
3
   8.3%
Fever > 39.5°C
0
   0.0%
1
   2.8%
Related fever
8
  11.8%
3
   8.3%
Any irritability
2
   2.9%
0
   0.0%
Grade 3 irritability
0
   0.0%
0
   0.0%
Related irritability
2
   2.9%
0
   0.0%
Any loss of appetite
1
   1.5%
1
   2.8%
Grade 3 loss of appetite
0
   0.0%
0
   0.0%
Related loss of appetite
1
   1.5%
1
   2.8%
9.Secondary Outcome
Title Number of Subjects Reporting Unsolicited AEs.
Hide Description Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any “solicited” symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame Within 31 days (Days 0-30) after vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 36
Measure Type: Count of Participants
Unit of Measure: Participants
31
  45.6%
18
  50.0%
10.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events (SAEs).
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the entire study period, from the vaccination visit at Day 0 up to the end of the follow-up visit at Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Total Vaccinated cohort included all vaccinated subjects.
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description:
Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
Overall Number of Participants Analyzed 68 36
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.5%
0
   0.0%
Time Frame Solicited AEs: Within 4 days (Days 0-3) after vaccination. Unsolicited AEs: Within 31 days (Days 0-30) after vaccination. SAEs: From Day 0 up to Month 1 for the Synflorix/Infanrix primed Group and up to Month 3 for the Synflorix/Infanrix unprimed Group.
Adverse Event Reporting Description Because of an issue discovered with the informed consent obtained for one child after the original statistical analysis. The data of the child, who also had an SAE that was not considered to be related to the study medication by the investigator, have been removed from the results tables.
 
Arm/Group Title Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Hide Arm/Group Description Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm. Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
All-Cause Mortality
Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/68 (1.47%)   0/36 (0.00%) 
General disorders     
Drowning *  1/68 (1.47%)  0/36 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Synflorix/Infanrix Primed Group Synflorix/Infanrix Unprimed Group
Affected / at Risk (%) Affected / at Risk (%)
Total   46/68 (67.65%)   25/36 (69.44%) 
Eye disorders     
Conjunctivitis *  3/68 (4.41%)  2/36 (5.56%) 
Gastrointestinal disorders     
Enteritis *  0/68 (0.00%)  2/36 (5.56%) 
General disorders     
Fever   8/68 (11.76%)  3/36 (8.33%) 
Pain   27/68 (39.71%)  13/36 (36.11%) 
Swelling   4/68 (5.88%)  2/36 (5.56%) 
Infections and infestations     
Respiratory tract infection *  13/68 (19.12%)  7/36 (19.44%) 
Malaria *  8/68 (11.76%)  10/36 (27.78%) 
Furuncle *  4/68 (5.88%)  1/36 (2.78%) 
Upper respiratory tract infection *  3/68 (4.41%)  2/36 (5.56%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Data were reanalyzed because an issue was discovered with the informed consent obtained for one child after the original statistical analysis. The child’s parent requested GlaxoSmithKline not to use the data of their child.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01153893     History of Changes
Other Study ID Numbers: 113199
First Submitted: June 29, 2010
First Posted: June 30, 2010
Results First Submitted: February 9, 2012
Results First Posted: March 15, 2012
Last Update Posted: September 20, 2018