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Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.

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ClinicalTrials.gov Identifier: NCT00871000
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 18, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Acellular Pertussis
Tetanus
Diphtheria
Poliomyelitis
Interventions Biological: Boostrix Polio™ 711866
Biological: Priorix Tetra TM 208136
Biological: Tetravac TM
Enrollment 303
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Period Title: Overall Study
Started 151 152
Completed 150 152
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Boostrix Polio Group Tetravac Group Total
Hide Arm/Group Description Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. Total of all reporting groups
Overall Number of Baseline Participants 151 152 303
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 152 participants 303 participants
5  (0.14) 5  (0.14) 5  (0.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 152 participants 303 participants
Female
81
  53.6%
68
  44.7%
149
  49.2%
Male
70
  46.4%
84
  55.3%
154
  50.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 151 participants 152 participants 303 participants
African heritage/African American
1
   0.7%
0
   0.0%
1
   0.3%
Asian-Central/South Asian heritage
1
   0.7%
4
   2.6%
5
   1.7%
White-Arabic/North African heritage
2
   1.3%
0
   0.0%
2
   0.7%
White-Caucasian/European heritage
147
  97.4%
147
  96.7%
294
  97.0%
Not specified
0
   0.0%
1
   0.7%
1
   0.3%
1.Primary Outcome
Title Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
9.207
(8.057 to 10.522)
21.393
(19.165 to 23.88)
Anti-T
12.527
(10.957 to 14.323)
11.07
(9.872 to 12.413)
2.Primary Outcome
Title Anti-poliovirus Types 1, 2 and 3 Antibody Titres
Hide Description Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 Number Analyzed 139 participants 144 participants
1145.6
(978.7 to 1340.9)
948
(817.5 to 1099.4)
Anti-Polio 2 Number Analyzed 139 participants 144 participants
1076.4
(908.7 to 1274.9)
1315.3
(1123.1 to 1540.3)
Anti-Polio 3 Number Analyzed 138 participants 144 participants
1937.8
(1631.4 to 2301.8)
1657.3
(1385.5 to 1982.6)
3.Primary Outcome
Title Number of Seroprotected Subjects Against Polio Types 1, 2 and 3
Hide Description A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-Polio 1 Number Analyzed 139 participants 144 participants
139
 100.0%
144
 100.0%
Anti-Polio 2 Number Analyzed 139 participants 144 participants
139
 100.0%
144
 100.0%
Anti-Polio 3 Number Analyzed 138 participants 144 participants
138
 100.0%
144
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Boostrix Polio Group, Tetravac Group
Comments To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 1 antibody titers ≥ 8 was ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-2.61 to 2.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boostrix Polio Group, Tetravac Group
Comments To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 2, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 2 antibody titers ≥ 8 was ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-2.61 to 2.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Boostrix Polio Group, Tetravac Group
Comments To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against polio type 3, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-polio type 3 antibody titers ≥ 8 was ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-2.61 to 2.72
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Seropositive Subjects for Anti-D and Anti-T Antibodies
Hide Description A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
139
 100.0%
144
 100.0%
Anti-T
139
 100.0%
144
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Boostrix Polio Group, Tetravac Group
Comments To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: Upper limit (UL) of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-D antibody concentrations ≥ 0.1 IU/mL was lower than or equal to (≤) 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-2.61 to 2.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Boostrix Polio Group, Tetravac Group
Comments To demonstrate that GSK Biologicals' Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD's Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: UL of the standardised asymptotic 95% CI on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-T antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-2.61 to 2.7
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Hide Description A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
138
  99.3%
144
 100.0%
Anti-T
137
  98.6%
143
  99.3%
6.Secondary Outcome
Title Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT
59.8
(52.2 to 68.5)
75.9
(65.7 to 87.7)
Anti-FHA
556.2
(491.4 to 629.5)
613.5
(547 to 688.2)
Anti-PRN
354.8
(280.2 to 449.4)
7.8
(6.5 to 9.2)
7.Secondary Outcome
Title Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Hide Description A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT
139
 100.0%
144
 100.0%
Anti-FHA
139
 100.0%
144
 100.0%
Anti-PRN
138
  99.3%
87
  60.4%
8.Secondary Outcome
Title Number of Seropositive Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
Hide Description Seropositivity was defined as: subjects with antibody concentrations ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 146
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-measles
139
 100.0%
146
 100.0%
Anti-mumps
139
 100.0%
144
  98.6%
Anti-rubella
139
 100.0%
145
  99.3%
Anti-varicella
135
  97.1%
140
  95.9%
9.Secondary Outcome
Title Anti-measles and Anti-varicella Antibody Concentrations
Hide Description Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 146
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-measles
2743.9
(2411.4 to 3122.2)
2863
(2534.6 to 3233.9)
Anti-varicella
856.7
(671.8 to 1092.4)
909.9
(721 to 1148.2)
10.Secondary Outcome
Title Anti-mumps Antibody Concentrations
Hide Description Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 146
Geometric Mean (95% Confidence Interval)
Unit of Measure: U/mL
4141.3
(3590.5 to 4776.5)
3837.6
(3275.1 to 4496.7)
11.Secondary Outcome
Title Anti-rubella Antibody Concentrations
Hide Description Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 146
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
154.5
(141.3 to 168.9)
162.5
(145.8 to 181)
12.Secondary Outcome
Title Number of Subjects With Booster Responses to Anti-D and Anti-T
Hide Description Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL). For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/mL), an increase in antibody concentrations of at least four times the pre-vaccination concentration.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 137 143
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D Number Analyzed 136 participants 143 participants
130
  95.6%
136
  95.1%
Anti-T Number Analyzed 137 participants 143 participants
137
 100.0%
142
  99.3%
13.Secondary Outcome
Title Number of Subjects With Booster Responses to Anti-polio Type 1, 2 and 3
Hide Description Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 139 144
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-Polio 1 Number Analyzed 139 participants 144 participants
115
  82.7%
112
  77.8%
Anti-Polio 2 Number Analyzed 139 participants 143 participants
113
  81.3%
122
  85.3%
Anti-Polio 3 Number Analyzed 138 participants 144 participants
126
  91.3%
127
  88.2%
14.Secondary Outcome
Title Number of Subjects With Booster Responses to Anti-PT, Anti-FHA and Anti-PRN
Hide Description Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the cut-off (post-vaccination concentration ≥ 20 EL.U/mL). For initially seropositive subjects with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL, an increase in antibody concentrations of at least four times the pre-vaccination concentration. For initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL, an increase in antibody concentrations of at least two times the pre-vaccination concentration.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 137 143
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 137 participants 141 participants
123
  89.8%
130
  92.2%
Anti-FHA Number Analyzed 136 participants 140 participants
129
  94.9%
134
  95.7%
Anti-PRN Number Analyzed 137 participants 143 participants
129
  94.2%
0
   0.0%
15.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella
Hide Description Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.
Time Frame At Month 1, one month post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had received the booster dose of study/comparator vaccine and for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component were available.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 36 34
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-measles Number Analyzed 2 participants 1 participants
2
 100.0%
1
 100.0%
Anti-mumps Number Analyzed 13 participants 13 participants
13
 100.0%
12
  92.3%
Anti-rubella Number Analyzed 0 participants 0 participants
0 0
Anti-varicella Number Analyzed 36 participants 34 participants
35
  97.2%
32
  94.1%
16.Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 151 152
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
96
  63.6%
96
  63.2%
Any Redness
58
  38.4%
66
  43.4%
Any Swelling
55
  36.4%
62
  40.8%
17.Secondary Outcome
Title Number of Subjects With Any Solicited General Symptoms
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 4-day (Days 0-3) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 151 152
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
40
  26.5%
36
  23.7%
Any Gastrointestinal
23
  15.2%
15
   9.9%
Any Headache
18
  11.9%
20
  13.2%
Any Temperature
32
  21.2%
30
  19.7%
18.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the 31-day (Days 0-30) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 151 152
Measure Type: Count of Participants
Unit of Measure: Participants
23
  15.2%
20
  13.2%
19.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide 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.
Time Frame During the whole study period (from Month 0 to Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description:
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
Overall Number of Participants Analyzed 151 152
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
Time Frame Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Month 0 to Month 1).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Boostrix Polio Group Tetravac Group
Hide Arm/Group Description Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm. Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
All-Cause Mortality
Boostrix Polio Group Tetravac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/152 (0.00%) 
Hide Serious Adverse Events
Boostrix Polio Group Tetravac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/152 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Boostrix Polio Group Tetravac Group
Affected / at Risk (%) Affected / at Risk (%)
Total   117/151 (77.48%)   117/152 (76.97%) 
General disorders     
Pain † 1  96/151 (63.58%)  96/152 (63.16%) 
Redness † 1  58/151 (38.41%)  66/152 (43.42%) 
Swelling † 1  55/151 (36.42%)  62/152 (40.79%) 
Fatigue † 1  40/151 (26.49%)  36/152 (23.68%) 
Gastrointestinal † 1  23/151 (15.23%)  15/152 (9.87%) 
Headache † 1  18/151 (11.92%)  20/152 (13.16%) 
Temperature † 1  32/151 (21.19%)  30/152 (19.74%) 
1
Term from vocabulary, MedDRA 13
†
Indicates events were collected by systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Ferrera G et al. A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.
Ferrera G et al. Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00871000    
Other Study ID Numbers: 111815
First Submitted: March 26, 2009
First Posted: March 30, 2009
Results First Submitted: March 7, 2017
Results First Posted: April 18, 2017
Last Update Posted: June 6, 2018