Trial Outcomes & Findings for Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines (NCT NCT00463437)
NCT ID: NCT00463437
Last Updated: 2020-01-02
Results Overview
Fever was measured as rectal temperature.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1437 participants
Primary outcome timeframe
During the 4-day (Day 0-3) period after the booster vaccination
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
359
|
363
|
358
|
357
|
|
Overall Study
COMPLETED
|
355
|
352
|
352
|
350
|
|
Overall Study
NOT COMPLETED
|
4
|
11
|
6
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
Baseline characteristics by cohort
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Total
n=1437 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
14.3 Months
STANDARD_DEVIATION 1.81 • n=93 Participants
|
14.3 Months
STANDARD_DEVIATION 1.74 • n=4 Participants
|
14.3 Months
STANDARD_DEVIATION 1.78 • n=27 Participants
|
14.3 Months
STANDARD_DEVIATION 1.78 • n=483 Participants
|
14.3 Months
STANDARD_DEVIATION 1.78 • n=36 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=93 Participants
|
176 Participants
n=4 Participants
|
195 Participants
n=27 Participants
|
171 Participants
n=483 Participants
|
724 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
177 Participants
n=93 Participants
|
187 Participants
n=4 Participants
|
163 Participants
n=27 Participants
|
186 Participants
n=483 Participants
|
713 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Day 0-3) period after the booster vaccinationPopulation: Analysis was performed on the Total vaccinated cohort from Pn-HibC and Pr-HibC Groups on subjects for whom data were available.
Fever was measured as rectal temperature.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=355 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=355 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)
|
—
|
—
|
11 subjects
|
8 subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) period after the booster vaccinationPopulation: Subjects from the Total Vaccinated cohort for whom data were available.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=356 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=357 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=355 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=355 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
196 subjects
|
195 subjects
|
193 subjects
|
165 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
194 subjects
|
183 subjects
|
186 subjects
|
173 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
162 subjects
|
148 subjects
|
150 subjects
|
134 subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0-3) period after the booster vaccinationPopulation: Subjects from the Total Vaccinated cohort for whom data were available.
Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=356 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=357 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=355 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=355 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Irritability
|
170 subjects
|
190 subjects
|
191 subjects
|
157 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Drowsiness
|
124 subjects
|
142 subjects
|
139 subjects
|
105 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Fever (≥ 38.0 °C)
|
109 subjects
|
122 subjects
|
105 subjects
|
108 subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Loss of appetite
|
101 subjects
|
99 subjects
|
112 subjects
|
93 subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) period after the booster vaccinationAn 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.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AE)
|
59 subjects
|
74 subjects
|
59 subjects
|
76 subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) period after the booster vaccinationAn SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
3 subjects
|
5 subjects
|
3 subjects
|
2 subjects
|
SECONDARY outcome
Timeframe: From the beginning of the study up to the end of the extended 6-month safety follow-up periodAn SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAE)
|
15 subjects
|
9 subjects
|
13 subjects
|
13 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-pneumococcal antibody concentration cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=158 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=158 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=160 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=153 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6B post (n=158,153,160,153)
|
157 subjects
|
151 subjects
|
158 subjects
|
153 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-1 pre (n=150,152,149, 151)
|
146 subjects
|
146 subjects
|
140 subjects
|
21 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-1 post (n=158,152,160,151)
|
158 subjects
|
152 subjects
|
160 subjects
|
28 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-4 pre (n=153,156,150,153)
|
152 subjects
|
156 subjects
|
147 subjects
|
150 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-4 post (n=158,153,160,152)
|
158 subjects
|
153 subjects
|
160 subjects
|
152 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-5 pre (n=149,146,146,148)
|
149 subjects
|
146 subjects
|
144 subjects
|
37 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-5 post (n=157,153,160,150)
|
157 subjects
|
153 subjects
|
160 subjects
|
64 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6B pre (n=151,155,150,151)
|
149 subjects
|
153 subjects
|
144 subjects
|
137 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-7F pre (n=149,153,148,151)
|
149 subjects
|
153 subjects
|
147 subjects
|
18 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-7F post (n=158,152,160,151)
|
158 subjects
|
152 subjects
|
160 subjects
|
25 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-9V pre (n=149,155,149,152)
|
149 subjects
|
154 subjects
|
149 subjects
|
152 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-9V post (n=158,153,160,153)
|
158 subjects
|
152 subjects
|
160 subjects
|
153 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-14 pre (n=153,158,152,153)
|
151 subjects
|
157 subjects
|
152 subjects
|
151 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-14 post (n=158,153,160,153)
|
158 subjects
|
153 subjects
|
160 subjects
|
153 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-18C pre (n=151,153,145,151)
|
149 subjects
|
151 subjects
|
145 subjects
|
151 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-18C post (n=157,152,160,152)
|
157 subjects
|
152 subjects
|
160 subjects
|
152 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19F pre (n=143,146,139,150)
|
143 subjects
|
146 subjects
|
139 subjects
|
143 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19F post (n=158,151,160,152)
|
158 subjects
|
151 subjects
|
160 subjects
|
152 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-23F pre (n=152,156,150,153)
|
149 subjects
|
153 subjects
|
144 subjects
|
141 subjects
|
|
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-23F post (n=158,153,160,153)
|
158 subjects
|
152 subjects
|
158 subjects
|
153 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Cut-off value for opsonophagocytic activity against pneumococcal antibody assessed was ≥ 8. The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=145 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=145 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=146 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=143 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-1 pre (n=144,145,141,143)
|
46 subjects
|
39 subjects
|
41 subjects
|
8 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-1 post (n=140,139,140,137)
|
132 subjects
|
133 subjects
|
127 subjects
|
12 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-4 pre (n=104,121,112,109)
|
61 subjects
|
67 subjects
|
61 subjects
|
73 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-4 post (n=137,134,140,135)
|
137 subjects
|
134 subjects
|
140 subjects
|
135 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-5 pre (n=116,114,117,124)
|
77 subjects
|
71 subjects
|
72 subjects
|
3 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-5 post (n=124,130,136,127)
|
121 subjects
|
127 subjects
|
131 subjects
|
4 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6B pre (n=133,132,133,137)
|
75 subjects
|
60 subjects
|
75 subjects
|
67 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-6B post (n=142,135,142,140)
|
134 subjects
|
127 subjects
|
135 subjects
|
138 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-7F pre (n=111,122,115,104)
|
109 subjects
|
117 subjects
|
109 subjects
|
42 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-7F post (n=140,137,139,112)
|
140 subjects
|
137 subjects
|
139 subjects
|
53 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-9V pre (n=133,133,130,130)
|
131 subjects
|
130 subjects
|
122 subjects
|
126 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-9V post (n=143,139,143,137)
|
143 subjects
|
139 subjects
|
143 subjects
|
137 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-14 pre (n=121,125,114,125)
|
115 subjects
|
116 subjects
|
107 subjects
|
124 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-14 post (n=137,138,138,134)
|
137 subjects
|
138 subjects
|
138 subjects
|
134 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-18C pre (n=126,118,123,123)
|
45 subjects
|
54 subjects
|
34 subjects
|
35 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-18C post (n=121,129,121,114)
|
121 subjects
|
127 subjects
|
121 subjects
|
110 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19F pre (n=127,135,134,134)
|
102 subjects
|
110 subjects
|
95 subjects
|
29 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-19F post (n=137,137,139,133)
|
133 subjects
|
132 subjects
|
139 subjects
|
131 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-23F pre (n=132,136,128,137)
|
121 subjects
|
120 subjects
|
105 subjects
|
124 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value
Opsono-23F post (n=145,143,146,143)
|
145 subjects
|
143 subjects
|
146 subjects
|
143 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-pneumococcal antibody cut-off value assessed was 0.05 microgram per milliliter (µg/mL). The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=157 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=153 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=160 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=152 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6A pre (n=145,144,144,149)
|
126 subjects
|
120 subjects
|
119 subjects
|
110 subjects
|
|
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-6A post (n=156,152,159,152)
|
152 subjects
|
145 subjects
|
149 subjects
|
148 subjects
|
|
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19A pre (n=145,153,145,151)
|
130 subjects
|
138 subjects
|
121 subjects
|
87 subjects
|
|
Number of Subjects With Cross-reactive Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value
Anti-19A post (n=157,153,160,152)
|
154 subjects
|
151 subjects
|
155 subjects
|
149 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-pneumococcal antibody cut-off value assessed was ≥ 8. The cross-reactive pneumococcal serotypes assessed include 6A and 19A.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=133 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=138 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=136 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=134 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value
Opsono-6A pre (n=108,110,106,110)
|
68 subjects
|
66 subjects
|
73 subjects
|
62 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value
Opsono-6A post (n=127,128,128,122)
|
116 subjects
|
119 subjects
|
117 subjects
|
119 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value
Opsono-19A pre (n=133,138,136,134)
|
4 subjects
|
11 subjects
|
4 subjects
|
2 subjects
|
|
Number of Subjects With Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes Above the Cut-off Value
Opsono-19A post (n=124,132,130,123)
|
77 subjects
|
75 subjects
|
50 subjects
|
29 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-protein D antibody cut-off value assessed was ≥ 100 Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per milliliter (EL.U/mL).
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=158 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=153 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=160 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=148 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Pre (n=147,153,147,146)
|
144 subjects
|
147 subjects
|
138 subjects
|
59 subjects
|
|
Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value
Post (n=158,152,160,148)
|
158 subjects
|
151 subjects
|
160 subjects
|
66 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Meningococcal serogroup C serum bactericidal assay titer cut-off value assessed was ≥ 8.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=89 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=84 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=79 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=78 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value
Pre (n=68,65,66,78)
|
57 subjects
|
62 subjects
|
62 subjects
|
68 subjects
|
|
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Titer Above the Cut-off Value
Post (n=89,84,79,76)
|
89 subjects
|
84 subjects
|
79 subjects
|
76 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-meningococcal polysaccharide C antibody cut-off value assessed was ≥ 0.3 µg/mL.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=156 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=149 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=159 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=149 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value
Pre (n=126,124,125,135)
|
95 subjects
|
82 subjects
|
105 subjects
|
102 subjects
|
|
Number of Subjects With Anti-meningococcal Polysaccharide C Antibody Concentrations Above the Cut-off Value
Post (n=156,149,159,149)
|
156 subjects
|
149 subjects
|
159 subjects
|
149 subjects
|
SECONDARY outcome
Timeframe: Before (pre) and one month after (post) the booster administrationPopulation: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity.
Anti-polyribosyl-ribitol phosphate antibody cut-off value assessed was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=157 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=153 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=160 Participants
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=152 Participants
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value
Pre (n=147,144,150,148)
|
122 subjects
|
128 subjects
|
145 subjects
|
143 subjects
|
|
Number of Subjects With Anti-polyribosyl-ribitol Phosphate Antibody Concentrations Above the Cut-off Value
Post (n=157,153,160,152)
|
157 subjects
|
153 subjects
|
160 subjects
|
152 subjects
|
Adverse Events
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
Serious events: 15 serious events
Other events: 297 other events
Deaths: 0 deaths
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
Serious events: 9 serious events
Other events: 303 other events
Deaths: 0 deaths
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
Serious events: 13 serious events
Other events: 302 other events
Deaths: 0 deaths
Prevenar™ + Menitorix™
Serious events: 13 serious events
Other events: 287 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 participants at risk
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.56%
2/359
|
1.1%
4/363
|
0.56%
2/358
|
0.84%
3/357
|
|
Infections and infestations
Pneumonia
|
0.56%
2/359
|
0.28%
1/363
|
0.00%
0/358
|
0.84%
3/357
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/359
|
0.28%
1/363
|
0.56%
2/358
|
0.56%
2/357
|
|
Gastrointestinal disorders
Gastroenteritis rotavirus
|
1.1%
4/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Infections and infestations
Bronchopneumonia
|
0.28%
1/359
|
0.28%
1/363
|
0.00%
0/358
|
0.56%
2/357
|
|
Infections and infestations
Bronchitis
|
0.28%
1/359
|
0.00%
0/363
|
0.28%
1/358
|
0.28%
1/357
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/359
|
0.28%
1/363
|
0.56%
2/358
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.56%
2/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/359
|
0.00%
0/363
|
0.00%
0/358
|
0.56%
2/357
|
|
Gastrointestinal disorders
Gastritis
|
0.28%
1/359
|
0.28%
1/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
Bronchpneumopathy
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/359
|
0.00%
0/363
|
0.00%
0/358
|
0.28%
1/357
|
|
Metabolism and nutrition disorders
Dehydration
|
0.28%
1/359
|
0.00%
0/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.28%
1/359
|
0.00%
0/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Infections and infestations
Laryngitis
|
0.00%
0/359
|
0.00%
0/363
|
0.00%
0/358
|
0.28%
1/357
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/359
|
0.00%
0/363
|
0.00%
0/358
|
0.28%
1/357
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/359
|
0.00%
0/363
|
0.28%
1/358
|
0.00%
0/357
|
|
Infections and infestations
Salmonellosis
|
0.28%
1/359
|
0.00%
0/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Infections and infestations
Tracheitis
|
0.28%
1/359
|
0.00%
0/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/359
|
0.28%
1/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Infections and infestations
Viral infection
|
0.00%
0/359
|
0.28%
1/363
|
0.00%
0/358
|
0.00%
0/357
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/359
|
0.28%
1/363
|
0.00%
0/358
|
0.00%
0/357
|
Other adverse events
| Measure |
GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™
n=359 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Wyeth's Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™
n=363 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals' DTPa-combined vaccine (Infanrix™ hexa in Germany \& Poland and Infanrix™ IPV Hib in Spain) and Baxter's Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
|
GSK's 10-valent Pneumococcal Vaccine 1024850A + Menitorix™
n=358 participants at risk
Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
Prevenar™ + Menitorix™
n=357 participants at risk
Subjects receiving a booster dose of Wyeth's pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany \& Poland and Infanrix™ IPV in Spain) and GSK Biologicals' combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
6/359
|
5.2%
19/363
|
3.9%
14/358
|
5.0%
18/357
|
|
General disorders
Pain
|
54.6%
196/359
|
53.7%
195/363
|
53.9%
193/358
|
46.2%
165/357
|
|
General disorders
Redness
|
54.0%
194/359
|
50.4%
183/363
|
52.0%
186/358
|
48.5%
173/357
|
|
General disorders
Swelling
|
45.1%
162/359
|
40.8%
148/363
|
41.9%
150/358
|
37.5%
134/357
|
|
General disorders
Drowsiness
|
34.5%
124/359
|
39.1%
142/363
|
38.8%
139/358
|
29.4%
105/357
|
|
General disorders
Fever
|
30.4%
109/359
|
33.6%
122/363
|
29.3%
105/358
|
30.3%
108/357
|
|
General disorders
Irritability
|
47.4%
170/359
|
52.3%
190/363
|
53.4%
191/358
|
44.0%
157/357
|
|
General disorders
Loss of appetite
|
28.1%
101/359
|
27.3%
99/363
|
31.3%
112/358
|
26.1%
93/357
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER