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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Pregnant Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377349
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : January 28, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Diphtheria-Tetanus-acellular Pertussis Vaccines
Interventions Biological: Boostrix™
Drug: Saline placebo
Enrollment 688
Recruitment Details A total of 725 pregnant subjects were screened of which 690 were randomized to 2 groups. Of these, 2 subjects were withdrawn before vaccination. Therefore 688 subjects were enrolled: 1 subject was excluded from the statistical analysis, leaving 687 subjects that comprised the Total Vaccinated cohort.
Pre-assignment Details Safety was assessed for infants born to vaccinated subjects as well as safety of dTap vaccination in the vaccinated pregnant subjects. There was also an assessment of the acceptance rate of a single dose of Boostrix among 723 eligible household contacts of the infants born to pregnant women enrolled in Spain, as part of an assessment of cocooning.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours). This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Period Title: Overall Study
Started 341 346
Completed 325 335
Not Completed 16 11
Reason Not Completed
Serious Adverse Event             1             0
Protocol Violation             3             2
Withdrawal by Subject             5             3
Lost to follow-up (partial vaccination)             1             0
Lost to follow-up (complete vaccination)             6             5
Other             0             1
Arm/Group Title dTpa Group - Mother Control Group - Mother Total
Hide Arm/Group Description This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours). This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours). Total of all reporting groups
Overall Number of Baseline Participants 341 346 687
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 341 participants 346 participants 687 participants
32.7  (4.4) 32.5  (4.3) 32.6  (4.35)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants 346 participants 687 participants
Female
341
 100.0%
346
 100.0%
687
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 341 participants 346 participants 687 participants
African Heritage / African American
3
   0.9%
9
   2.6%
12
   1.7%
American Indian or Alaskan Native
2
   0.6%
0
   0.0%
2
   0.3%
Asian - Central/South Asian Heritage
3
   0.9%
0
   0.0%
3
   0.4%
Asian - East Asian Heritage
4
   1.2%
1
   0.3%
5
   0.7%
Asian - Japanese Heritage
1
   0.3%
0
   0.0%
1
   0.1%
Asian - South East Asian Heritage
1
   0.3%
1
   0.3%
2
   0.3%
White - Arabic / North African Heritage
3
   0.9%
7
   2.0%
10
   1.5%
White - Caucasian / European Heritage
314
  92.1%
319
  92.2%
633
  92.1%
Unspecified
10
   2.9%
9
   2.6%
19
   2.8%
1.Primary Outcome
Title Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood Samples
Hide Description Antibody concentrations were assessed by Enzyme-linked immunosorbent assay (ELISA), tabulated as Geometric Mean Concentrations (GMCs) and expressed in International units per mililiter (IU/mL) for the following assay cut-offs: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.
Time Frame At delivery - Visit 3 (anytime after 28 weeks of gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 291 292
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-PT Number Analyzed 290 participants 292 participants
46.9
(41.2 to 53.3)
5.5
(4.8 to 6.3)
Anti-FHA Number Analyzed 291 participants 292 participants
366.1
(329 to 407.3)
22.7
(19.7 to 26.2)
Anti-PRN Number Analyzed 290 participants 291 participants
301.8
(250.9 to 362.9)
14.6
(12.1 to 17.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection dTpa Group - Mother, Control Group - Mother
Comments GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.
Type of Statistical Test Superiority
Comments Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-PT antibodies was greater than or equal to (≥) 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 2-sample t-test
Comments The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 8.47
Confidence Interval (2-Sided) 95%
7.02 to 10.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection dTpa Group - Mother, Control Group - Mother
Comments GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.
Type of Statistical Test Superiority
Comments Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-FHA antibodies was greater than or equal to (≥) 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 2-sample t-test
Comments The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 16.11
Confidence Interval (2-Sided) 95%
13.48 to 19.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection dTpa Group - Mother, Control Group - Mother
Comments GMC ratio between groups (dTpa Group-Mother/Control Group-Mother) to demonstrate that maternally transferred antibodies against pertussis in the dTpa Group-Mother was superior to that in the Control Group-mother, in the cord blood sample at the time of delivery.
Type of Statistical Test Superiority
Comments Criterion: The lower limit (LL) of the 95% confidence interval (CI) of the GMC ratio [dTpa Group-Mother/Control Group-Mother] for anti-PRN antibodies was greater than or equal to (≥) 1.5.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method 2-sample t-test
Comments The CI of the group GMC ratio were computed using two-sample t-test assuming heterogeneity of variance.
Method of Estimation Estimation Parameter GMC ratio
Estimated Value 20.65
Confidence Interval (2-Sided) 95%
15.86 to 26.88
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects by Pregnancy Outcomes
Hide Description Pregnancy outcomes included live birth with no congenital anomalies, live birth with congenital anomalies, still birth with no congenital anomalies, still birth with congenital anomalies, elective termination with no congenital anomalies and elective termination with congenital anomalies. No subjects with still birth or elective termination of infant were reported.
Time Frame From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the Total Vaccinated cohort (TVC) which included all subjects with the study vaccine administration documented.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 341 346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Live infant No apparent congenital anomaly
97.4
(95 to 98.8)
97.4
(95.1 to 98.8)
Live infant congenital anomaly
2.6
(1.2 to 5)
2.3
(1 to 4.5)
Lost to follow-up
0
(0 to 1.1)
0.3
(0 to 1.6)
3.Secondary Outcome
Title Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of Interest
Hide Description Listed pregnancy-related adverse events of interest/ neonate-related events of interest included gestational diabetes, pregnancy-related hypertension, premature rupture of mem-branes, preterm premature rupture of membranes, premature labour, premature uterine contractions, intrauterine growth restriction/poor foetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine haemorrhage, maternal death, preterm birth, neonatal death, small for gestational age, neonatal hypoxic ischaemic encephalopathy and failure to thrive/growth deficiency were reported.
Time Frame From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed on the TVC which included all subjects with the study vaccine administration documented.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 341 346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Intrauterine growth restriction/poor foetal growth
1.5
(0.5 to 3.4)
0.6
(0.1 to 2.1)
Pre-eclampsia
0.3
(0 to 1.6)
1.4
(0.5 to 3.3)
Pregnancy-related hypertension
1.2
(0.3 to 3)
1.4
(0.5 to 3.3)
Premature labour
3.8
(2 to 6.4)
3.2
(1.6 to 5.6)
Premature rupture of membranes
3.8
(2 to 6.4)
4.3
(2.4 to 7)
Premature uterine contractions
0.6
(0.1 to 2.1)
0.9
(0.2 to 2.5)
Preterm birth
3.2
(1.6 to 5.7)
2.6
(1.2 to 4.9)
Preterm premature rupture of membranes
1.2
(0.3 to 3)
2
(0.8 to 4.1)
Small for gestational age
0.6
(0.1 to 2.1)
0.6
(0.1 to 2.1)
Vaginal or intrauterine haemorrhage
2.6
(1.2 to 5)
2.9
(1.4 to 5.3)
4.Secondary Outcome
Title Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN
Hide Description A seroprotected subject against diphteria and tetanus was a subject with antibody concentration ≥ 0.1 IU/mL. A seropositive subject was a subjects with antibody concentration ≥ 2.693 IU/mL for anti-PT, ≥ 2.046 IU/mL for anti-FHA and ≥ 2.187 IU/mL for anti-PRN.
Time Frame One month post vaccination (Day 30) during pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 290 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-D Number Analyzed 290 participants 289 participants
97.6
(95.1 to 99)
70.6
(65 to 75.8)
Anti-T Number Analyzed 290 participants 292 participants
100
(98.7 to 100)
96.6
(93.8 to 98.3)
Anti-PT Number Analyzed 289 participants 292 participants
98.6
(96.5 to 99.6)
61.3
(55.5 to 66.9)
Anti-FHA Number Analyzed 290 participants 291 participants
100
(98.7 to 100)
94.5
(91.2 to 96.8)
Anti-PRN Number Analyzed 290 participants 291 participants
100
(98.7 to 100)
84.5
(79.9 to 88.5)
5.Secondary Outcome
Title Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL.
Time Frame One month post vaccination (Day 30) during pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 290 292
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D Number Analyzed 290 participants 289 participants
2.19
(1.87 to 2.57)
0.23
(0.19 to 0.27)
Anti-T Number Analyzed 290 participants 292 participants
8.43
(7.72 to 9.2)
0.98
(0.86 to 1.11)
Anti-PT Number Analyzed 289 participants 292 participants
45.6
(40.4 to 51.5)
4.1
(3.6 to 4.6)
Anti-FHA Number Analyzed 290 participants 291 participants
317.5
(285 to 353.8)
15
(13.1 to 17.2)
Anti-PRN Number Analyzed 290 participants 291 participants
283.6
(237.1 to 339.1)
10.5
(8.7 to 12.5)
6.Secondary Outcome
Title Percentage of Subjects With Vaccine Response to Anti-D and Anti-T
Hide Description

Vaccine response for anti-D and anti-T was defined as:

for initially seronegative subjects (S-) with pre-vaccination concentration below cut-off: < 0.1 IU/mL) was an antibody concentration at least four times the assay cut-off (post-vaccination concentration ≥ 0.4 IU/mL); for initially seropositive subjects (S+) with pre-vaccination concentration ≥ 0.1 IU/mL): an increase in antibody concentrations of at least four times the pre-vaccination concentration.

Time Frame One month post vaccination (Day 30) during pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 288 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-D, S- Number Analyzed 103 participants 83 participants
64.1
(54 to 73.3)
0
(0 to 4.3)
Anti-D, S+ Number Analyzed 184 participants 205 participants
75
(68.1 to 81.1)
0
(0 to 1.8)
Anti-D, Total Number Analyzed 287 participants 288 participants
71.1
(65.5 to 76.3)
0
(0 to 1.3)
Anti-T, S- Number Analyzed 12 participants 10 participants
100
(73.5 to 100)
0
(0 to 30.8)
Anti-T, S+ Number Analyzed 276 participants 281 participants
67.8
(61.9 to 73.2)
0
(0 to 1.3)
Anti-T, Total Number Analyzed 288 participants 291 participants
69.1
(63.4 to 74.4)
0
(0 to 1.3)
7.Secondary Outcome
Title Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN
Hide Description Vaccine response to PT, FHA and PRN antigens is defined as: for subjects with pre-vaccination antibody concentration below the assay cut-off (S-), post-vaccination anti-body concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off (S+), post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and for subjects with pre-vaccination antibody concentration ≥4 times the assay cut-off (S+), post-vaccination antibody concentration ≥2 times the pre-vaccination antibody concentration.
Time Frame One month post vaccination (Day 30) during pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 2 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 288 291
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-PT, S- Number Analyzed 121 participants 107 participants
82.6
(74.7 to 88.9)
0.9
(0 to 5.1)
Anti-PT, S+ (<4 cut-off) Number Analyzed 108 participants 117 participants
90.7
(83.6 to 95.5)
0
(0 to 3.1)
Anti-PT, S+ (≥4 cut-off) Number Analyzed 58 participants 67 participants
93.1
(83.3 to 98.1)
3
(0.4 to 10.4)
Anti-PT, Total Number Analyzed 287 participants 291 participants
87.8
(83.4 to 91.4)
1
(0.2 to 3)
Anti-FHA, S- Number Analyzed 16 participants 16 participants
100
(79.4 to 100)
0
(0 to 20.6)
Anti-FHA, S+ (<4 cut-off) Number Analyzed 84 participants 65 participants
100
(95.7 to 100)
0
(0 to 5.5)
Anti-FHA, S+ (≥4 cut-off) Number Analyzed 188 participants 209 participants
89.9
(84.7 to 93.8)
1.9
(0.5 to 4.8)
Anti-FHA, Total Number Analyzed 288 participants 290 participants
93.4
(89.9 to 96)
1.4
(0.4 to 3.5)
Anti-PRN, S- Number Analyzed 45 participants 43 participants
86.7
(73.2 to 94.9)
0
(0 to 8.2)
Anti-PRN, S+ (<4 cut-off) Number Analyzed 98 participants 86 participants
95.9
(89.9 to 98.9)
0
(0 to 4.2)
Anti-PRN, S+ (≥4 cut-off) Number Analyzed 145 participants 161 participants
86.2
(79.5 to 91.4)
1.2
(0.2 to 4.4)
Anti-PRN Total Number Analyzed 288 participants 290 participants
89.6
(85.5 to 92.9)
0.7
(0.1 to 2.5)
8.Secondary Outcome
Title Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood Samples
Hide Description For this assay the anti-PT, anti-FHA and anti-PRN seropositivity status was determined from the cord blood samples. The seropositivity cut-offs were the following: 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN.
Time Frame At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the According to protocol cohort for immunogenicity , which included all evaluable subjects who complied with the vaccine administration, who had cord blood collected at least 21 days post-vaccination and for whom data concerning antibodies against at least 1 study vaccine antigen component at Visit 3 were available.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 291 292
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-PT Number Analyzed 290 participants 292 participants
98.6
(96.5 to 99.6)
68.8
(63.2 to 74.1)
Anti-FHA Number Analyzed 291 participants 292 participants
100
(98.7 to 100)
96.6
(93.8 to 98.3)
Anti-PRN Number Analyzed 290 participants 291 participants
99.7
(98.1 to 100)
88
(83.7 to 91.5)
9.Secondary Outcome
Title Percentage of Subjects With Solicited Local Adverse Events (AEs)
Hide Description Assessed solicited local symptoms were pain, redness and swelling. "Any" = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time Frame During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 335 343
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Any Pain, Dose 1 Number Analyzed 335 participants 343 participants
86.3
(82.1 to 89.8)
14.6
(11 to 18.8)
Any Redness (mm), Dose 1 Number Analyzed 335 participants 343 participants
28.7
(23.9 to 33.8)
12.8
(9.5 to 16.8)
Any Swelling (mm), Dose 1 Number Analyzed 335 participants 343 participants
25.1
(20.5 to 30.1)
3.5
(1.8 to 6)
Any Pain, Dose 2 Number Analyzed 324 participants 330 participants
12.7
(9.2 to 16.8)
62.7
(57.3 to 68)
Any Redness (mm), Dose 2 Number Analyzed 324 participants 330 participants
10.5
(7.4 to 14.4)
29.7
(24.8 to 34.9)
Any Swelling (mm), Dose 2 Number Analyzed 324 participants 330 participants
5.2
(3.1 to 8.3)
26.4
(21.7 to 31.5)
10.Secondary Outcome
Title Percentage of Subjects With Solicited General AEs
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache and fever [defined as oral, axillary or tympanic temperature ≥ 37.5 degrees Celsius (°C) or rectal temperature ≥ 38.0 °C]. "Any" = any report of the specified symptom irrespective of intensity grade. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time Frame During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
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Hide Analysis Population Description
The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 335 342
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Any Fatigue, Dose 1 Number Analyzed 335 participants 342 participants
43.6
(38.2 to 49.1)
36.3
(31.2 to 41.6)
Any Gastrointestinal symptom, Dose 1 Number Analyzed 335 participants 342 participants
17.9
(14 to 22.4)
15.2
(11.6 to 19.5)
Any Headache, Dose 1 Number Analyzed 335 participants 342 participants
24.8
(20.2 to 29.8)
22.8
(18.5 to 27.6)
Any Temperature/(Axillary) (°C), Dose 1 Number Analyzed 335 participants 342 participants
1.2
(0.3 to 3)
0.9
(0.2 to 2.5)
Any Fatigue, Dose 2 Number Analyzed 324 participants 331 participants
40.1
(34.7 to 45.7)
46.2
(40.8 to 51.8)
Any Gastrointestinal symptom, Dose 2 Number Analyzed 324 participants 331 participants
9.9
(6.9 to 13.7)
12.7
(9.3 to 16.8)
Any Headache, Dose 2 Number Analyzed 324 participants 331 participants
23.1
(18.7 to 28.1)
23.6
(19.1 to 28.5)
Any Temperature/(Axillary) (°C), Dose 2 Number Analyzed 324 participants 331 participants
4.6
(2.6 to 7.5)
9.1
(6.2 to 12.7)
11.Secondary Outcome
Title Percentage of Subjects With Unsolicited AEs
Hide Description An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Dose 1 = pregnancy dose at Day 0 - Visit 1, Dose 2 = post-delivery dose at birth - Visit 3.
Time Frame Within 31 days (Day 0 - Day 30) after each vaccination
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Hide Analysis Population Description
The analysis was done on the TVC, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
Arm/Group Title dTpa Group - Mother Control Group - Mother
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
Overall Number of Participants Analyzed 341 346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Any unsolicited AE, Dose 1 Number Analyzed 341 participants 346 participants
38.7
(33.5 to 44.1)
35.5
(30.5 to 40.8)
Any unsolicited AE, Dose 2 Number Analyzed 336 participants 342 participants
30.7
(25.8 to 35.9)
32.2
(27.2 to 37.4)
12.Secondary Outcome
Title Percentage of Infants With Unsolicited AEs
Hide Description An unsolicited AE was any AE that was not solicited using a subject diary and that was spontaneously communicated by the subject. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame From delivery to Month 2 post delivery (Visit 4, end of the study).
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Hide Analysis Population Description
The analysis was done on the TVC of Mother, which included all subjects with the study vaccine administration documented and who had returned their diary cards.
Arm/Group Title dTpa Group - Infant Control Group - Infnat
Hide Arm/Group Description:
This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.
This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy.
Overall Number of Participants Analyzed 341 346
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
26.4
(21.8 to 31.4)
22.3
(18.0 to 27.0)
13.Secondary Outcome
Title Number of Subjects With Serious AEs (SAEs)
Hide Description A SAE was any untoward medical occurrence that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.
Time Frame From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was done on the TVC, which included all subjects with the study vaccine administration documented.
Arm/Group Title dTpa Group - Mother Control Group - Mother dTpa Group - Infant Control Group - Infant Household Group
Hide Arm/Group Description:
This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours).
This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. 27 weeks until 36 completed weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours).
This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy.
This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy
This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Overall Number of Participants Analyzed 341 346 341 346 608
Measure Type: Count of Participants
Unit of Measure: Participants
51
  15.0%
52
  15.0%
52
  15.2%
45
  13.0%
0
   0.0%
14.Secondary Outcome
Title Percentage of Household Contacts of the Infants Born to Pregnant Women Vaccinated in Spain
Hide Description This analysis assessed the vaccination status of the household contacts (who accepted, received or refused vaccination) and also the reasons for refusal (not coming to site, refused to be vaccinated, unspecified) as part of an assessment of cocooning among the eligible household contacts.
Time Frame From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
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Hide Analysis Population Description
This analysis was done on the Total cohort for household contacts in Spain, which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain.
Arm/Group Title Household Group
Hide Arm/Group Description:
This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Overall Number of Participants Analyzed 723
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of household contacts
Accepted vaccination
84.4
(81.5 to 86.9)
Received vaccination
84.1
(81.2 to 86.7)
Refused vaccination
15.6
(13.1 to 18.5)
Not coming to site
1.4
(0.7 to 2.5)
Refused to be vaccinated
13.4
(11 to 16.1)
Unspecified
0.8
(0.3 to 1.8)
15.Secondary Outcome
Title Percentage of Household Contacts With SAEs
Hide Description SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame During the 31-day (Days 0-30) follow-up period post-vaccination (Boostrix administered preferably 2 weeks before the birth of the infant, Visit 3).
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was done on the Total cohort for household contacts which included all eligible household contacts of the infants born to pregnant women vaccinated in Spain. For the analysis of safety, all vaccinated household contacts are considered.
Arm/Group Title Household Group
Hide Arm/Group Description:
This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
Overall Number of Participants Analyzed 723
Measure Type: Number
Unit of Measure: Percentage of subjects
0
Time Frame For the Mothers` Groups: Solicited local and general AEs were reported during Days 0 - 7 following each dose. Unsolicited AEs were reported during Days 0 - 30 following each dose. SAEs were reported during the entire study period (Day 0 up to Month 2). For the Infants` Groups: unsolicited AEs and SAEs were reported From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study). For the Household Group: SAEs were reported during the 31-day (Days 0-30) follow-up period post-vaccination.
Adverse Event Reporting Description No solicited symptoms were assessed for the Infants` Groups and Household Group.
 
Arm/Group Title dTpa Group-Mother Control Group-Mother dTpa Group - Infant Control Group-Infant Household Group
Hide Arm/Group Description This group consisted of pregnant women who received a single dose of Boostrix at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of the placebo post-delivery (within 72 hours). This group consisted of pregnant women who received a single dose of placebo at 27-36 weeks (i.e. completed 27 weeks until 36 weeks) of gestation (Visit 1) and received a dose of Boostrix post-delivery (within 72 hours). This group consisted of infants born to mothers (from dTpa Group Mother) who received a dose of Boostrix during pregnancy. This group consisted of infants born to mothers (from Control Group Mother) who received a dose of placebo during pregnancy This group consisted of eligible household contacts of the infants born to pregnant women enrolled in Spain who received a single dose of Boostrix anytime during the study.
All-Cause Mortality
dTpa Group-Mother Control Group-Mother dTpa Group - Infant Control Group-Infant Household Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/341 (0.00%)      0/346 (0.00%)      0/341 (0.00%)      0/346 (0.00%)      0/608 (0.00%)    
Hide Serious Adverse Events
dTpa Group-Mother Control Group-Mother dTpa Group - Infant Control Group-Infant Household Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/341 (14.96%)      52/346 (15.03%)      52/341 (15.25%)      45/346 (13.01%)      0/608 (0.00%)    
Blood and lymphatic system disorders           
Anaemia neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Isoimmune haemolytic disease  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Cardiac disorders           
Atrioventricular block complete  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Supraventricular tachycardia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Congenital, familial and genetic disorders           
Atrial septal defect  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Cardiac septal defect  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Congenital cardiovascular anomaly  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Congenital hydronephrosis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Cryptorchism  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 3/346 (0.87%)  3 0/608 (0.00%)  0
Hypospadias  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Microtia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Polydactyly  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
Pyloric stenosis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Syndactyly  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Transposition of the great vessels  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Trisomy 21  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Ventricular septal defect  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Gastrointestinal disorders           
Gastrooesophageal reflux disease  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Vomiting  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
General disorders           
Pyrexia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Hepatobiliary disorders           
Hyperbilirubinaemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 3/341 (0.88%)  3 1/346 (0.29%)  1 0/608 (0.00%)  0
Hyperbilirubinaemia neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Jaundice  1  0/341 (0.00%)  0 0/346 (0.00%)  0 8/341 (2.35%)  8 6/346 (1.73%)  6 0/608 (0.00%)  0
Infections and infestations           
Amniotic cavity infection  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Beta haemolytic streptococcal infection  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Bronchiolitis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 3/341 (0.88%)  3 2/346 (0.58%)  2 0/608 (0.00%)  0
Endometritis decidual  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Enterovirus infection  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Gastroenteritis  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Influenza  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Mastitis  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nasopharyngitis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Neonatal infection  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 1/346 (0.29%)  1 0/608 (0.00%)  0
Perineal infection  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pneumonia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory syncytial virus bronchiolitis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
Sepsis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Sepsis neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 2/346 (0.58%)  2 0/608 (0.00%)  0
Superinfection bacterial  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Tracheitis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Upper respiratory tract infection  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Urinary tract infection  1  1/341 (0.29%)  1 0/346 (0.00%)  0 2/341 (0.59%)  2 1/346 (0.29%)  1 0/608 (0.00%)  0
Injury, poisoning and procedural complications           
Fall  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Procedural haemorrhage  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Investigations           
Cardiac murmur  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Metabolism and nutrition disorders           
Dehydration  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 1/346 (0.29%)  1 0/608 (0.00%)  0
Hypernatraemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Hypocalcaemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
Hypoglycaemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 2/346 (0.58%)  2 0/608 (0.00%)  0
Hypoglycaemia neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Neonatal hypocalcaemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Nervous system disorders           
Hypotonia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Somnolence neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Cephalhaematoma  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 1/346 (0.29%)  1 0/608 (0.00%)  0
Foetal distress syndrome  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Foetal growth restriction  1  3/341 (0.88%)  3 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Gestational hypertension  1  4/341 (1.17%)  4 4/346 (1.16%)  4 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hellp syndrome  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Jaundice neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
Large for dates baby  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Placenta praevia haemorrhage  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Polyhydramnios  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Postpartum haemorrhage  1  5/341 (1.47%)  5 7/346 (2.02%)  7 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pre-eclampsia  1  1/341 (0.29%)  1 5/346 (1.45%)  5 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Premature baby  1  0/341 (0.00%)  0 0/346 (0.00%)  0 11/341 (3.23%)  11 9/346 (2.60%)  9 0/608 (0.00%)  0
Premature delivery  1  4/341 (1.17%)  4 4/346 (1.16%)  4 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Premature labour  1  11/341 (3.23%)  12 11/346 (3.18%)  11 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Premature rupture of membranes  1  13/341 (3.81%)  13 17/346 (4.91%)  17 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Preterm premature rupture of membranes  1  4/341 (1.17%)  4 5/346 (1.45%)  5 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Retained placenta or membranes  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Small for dates baby  1  0/341 (0.00%)  0 0/346 (0.00%)  0 3/341 (0.88%)  3 3/346 (0.87%)  3 0/608 (0.00%)  0
Threatened labour  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine contractions during pregnancy  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Hydronephrosis  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vesicoureteric reflux  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Reproductive system and breast disorders           
Female genital tract fistula  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Metrorrhagia  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine atony  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine haemorrhage  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vaginal haemorrhage  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Apnoea  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Asphyxia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Dyspnoea  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Meconium aspiration syndrome  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Neonatal asphyxia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Neonatal respiratory depression  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Pneumothorax  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Pulmonary embolism  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory distress  1  0/341 (0.00%)  0 0/346 (0.00%)  0 5/341 (1.47%)  5 4/346 (1.16%)  4 0/608 (0.00%)  0
Transient tachypnoea of the newborn  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Skin and subcutaneous tissue disorders           
Rash neonatal  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Vascular disorders           
Deep vein thrombosis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
dTpa Group-Mother Control Group-Mother dTpa Group - Infant Control Group-Infant Household Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   321/341 (94.13%)      303/346 (87.57%)      33/341 (9.68%)      29/346 (8.38%)      0/608 (0.00%)    
Blood and lymphatic system disorders           
Anaemia  1  11/341 (3.23%)  11 14/346 (4.05%)  14 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Anaemia of pregnancy  1  3/341 (0.88%)  3 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Cardiac disorders           
Bradycardia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Supraventricular extrasystoles  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Ear and labyrinth disorders           
Deafness  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Ear pain  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Endocrine disorders           
Hypothyroidism  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Thyroid dysfunction in pregnancy  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Eye disorders           
Conjunctival haemorrhage  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Dacryostenosis acquired  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 0/346 (0.00%)  0 0/608 (0.00%)  0
Eczema eyelids  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastrointestinal disorders           
Abdominal discomfort  1  3/341 (0.88%)  3 1/346 (0.29%)  1 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Abdominal pain  1  4/341 (1.17%)  5 1/346 (0.29%)  1 9/341 (2.64%)  9 6/346 (1.73%)  6 0/608 (0.00%)  0
Abdominal pain lower  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Abdominal pain upper  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Constipation  1  8/341 (2.35%)  8 10/346 (2.89%)  10 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Diarrhoea  1  3/341 (0.88%)  3 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Dyspepsia  1  4/341 (1.17%)  4 4/346 (1.16%)  5 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Flatulence  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastritis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastrointestinal disorder  1  78/341 (22.87%)  92 83/346 (23.99%)  95 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastrooesophageal reflux disease  1  7/341 (2.05%)  7 6/346 (1.73%)  6 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Haemorrhoids  1  4/341 (1.17%)  4 7/346 (2.02%)  7 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Inguinal hernia  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Stomatitis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Toothache  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Umbilical hernia  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vomiting  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
General disorders           
Asthenia  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Axillary pain  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Chills  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Discomfort  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Fatigue  1  188/341 (55.13%)  276 186/346 (53.76%)  277 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Granuloma  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hypothermia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Impaired healing  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Influenza like illness  1  3/341 (0.88%)  3 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site bruising  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site erythema  1  106/341 (31.09%)  130 117/346 (33.82%)  142 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site haematoma  1  0/341 (0.00%)  0 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site induration  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site mass  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site pain  1  290/341 (85.04%)  330 223/346 (64.45%)  258 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site pruritus  1  4/341 (1.17%)  4 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site rash  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site reaction  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site swelling  1  91/341 (26.69%)  101 92/346 (26.59%)  99 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injection site urticaria  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Malaise  1  0/341 (0.00%)  0 1/346 (0.29%)  1 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Nodule  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Peripheral swelling  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pyrexia  1  20/341 (5.87%)  20 32/346 (9.25%)  33 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Swelling  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vaccination site pain  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vessel puncture site bruise  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hepatobiliary disorders           
Cholestasis of pregnancy  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hyperbilirubinaemia  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 2/346 (0.58%)  2 0/608 (0.00%)  0
Jaundice  1  0/341 (0.00%)  0 0/346 (0.00%)  0 2/341 (0.59%)  2 5/346 (1.45%)  5 0/608 (0.00%)  0
Immune system disorders           
Milk allergy  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Seasonal allergy  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Infections and infestations           
Amniotic cavity infection  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Bronchiolitis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Bronchitis  1  0/341 (0.00%)  0 1/346 (0.29%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Conjunctivitis  1  1/341 (0.29%)  1 3/346 (0.87%)  3 7/341 (2.05%)  8 3/346 (0.87%)  3 0/608 (0.00%)  0
Cystitis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Endometritis  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Fungal infection  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Fungal skin infection  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastroenteritis  1  6/341 (1.76%)  6 1/346 (0.29%)  1 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Gastroenteritis viral  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Genital herpes  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Genital infection  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Genital infection fungal  1  0/341 (0.00%)  0 1/346 (0.29%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Groin abscess  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Herpes simplex  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hordeolum  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Influenza  1  2/341 (0.59%)  2 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Mastitis  1  10/341 (2.93%)  10 14/346 (4.05%)  14 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Mastitis postpartum  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nasopharyngitis  1  7/341 (2.05%)  7 12/346 (3.47%)  12 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nipple infection  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Oral candidiasis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 1/346 (0.29%)  1 0/608 (0.00%)  0
Oral herpes  1  1/341 (0.29%)  1 1/346 (0.29%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Otitis media acute  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Periodontitis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pharyngitis  1  2/341 (0.59%)  2 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pneumonia  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Postoperative abscess  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Postoperative wound infection  1  2/341 (0.59%)  2 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pyelonephritis  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory tract infection  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory tract infection viral  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 2/346 (0.58%)  2 0/608 (0.00%)  0
Rhinitis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Sinusitis  1  2/341 (0.59%)  2 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Tinea pedis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Upper respiratory tract infection  1  11/341 (3.23%)  12 13/346 (3.76%)  13 3/341 (0.88%)  3 1/346 (0.29%)  1 0/608 (0.00%)  0
Urinary tract infection  1  8/341 (2.35%)  8 10/346 (2.89%)  11 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vaginal infection  1  1/341 (0.29%)  1 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vulvovaginal candidiasis  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vulvovaginal mycotic infection  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Injury, poisoning and procedural complications           
Clavicle fracture  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 2/346 (0.58%)  2 0/608 (0.00%)  0
Dislocation of vertebra  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Foreign body  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Incision site pain  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Joint injury  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Laceration  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Ligament sprain  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Post procedural haematoma  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Post procedural inflammation  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Procedural haemorrhage  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Procedural headache  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Procedural pain  1  3/341 (0.88%)  3 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Suture related complication  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Suture rupture  1  1/341 (0.29%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Wound dehiscence  1  1/341 (0.29%)  1 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Investigations           
Blood pressure increased  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Heart rate decreased  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Metabolism and nutrition disorders           
Cow's milk intolerance  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Fluid retention  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Iron deficiency  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Arthralgia  1  3/341 (0.88%)  3 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Back pain  1  11/341 (3.23%)  11 13/346 (3.76%)  14 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Flank pain  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Ligament pain  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Limb discomfort  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Muscle haemorrhage  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Musculoskeletal stiffness  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Myalgia  1  3/341 (0.88%)  3 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Neck pain  1  1/341 (0.29%)  1 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pain in extremity  1  2/341 (0.59%)  2 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Anogenital warts  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Melanocytic naevus  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Nervous system disorders           
Aphonia  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Dizziness  1  7/341 (2.05%)  8 4/346 (1.16%)  4 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Extrapyramidal disorder  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Headache  1  129/341 (37.83%)  169 126/346 (36.42%)  169 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Migraine  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Migraine with aura  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Paraesthesia  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Paralysis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Restless legs syndrome  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Sciatica  1  1/341 (0.29%)  1 2/346 (0.58%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Somnolence  1  1/341 (0.29%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Syncope  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pregnancy, puerperium and perinatal conditions           
Afterbirth pain  1  17/341 (4.99%)  17 20/346 (5.78%)  20 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Cephalhaematoma  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Cervical dilatation  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Labour pain  1  2/341 (0.59%)  2 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Oligohydramnios  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Small for dates baby  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Traumatic delivery  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine contractions during pregnancy  1  3/341 (0.88%)  3 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine hypotonus  1  3/341 (0.88%)  3 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine irritability  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Psychiatric disorders           
Affect lability  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Depression  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Insomnia  1  0/341 (0.00%)  0 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Irritability  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Renal and urinary disorders           
Dysuria  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pyelocaliectasis  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Renal colic  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Urethral prolapse  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Reproductive system and breast disorders           
Breast engorgement  1  2/341 (0.59%)  2 4/346 (1.16%)  4 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Breast inflammation  1  2/341 (0.59%)  2 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Breast mass  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Breast pain  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Cervical discharge  1  1/341 (0.29%)  1 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Menorrhagia  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Metrorrhagia  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nipple disorder  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nipple inflammation  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nipple pain  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Ovarian cyst torsion  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Pelvic pain  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Perineal pain  1  0/341 (0.00%)  0 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pruritus genital  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Suppressed lactation  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine pain  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Uterine prolapse  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vaginal discharge  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Varicose veins vulval  1  0/341 (0.00%)  0 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vulvovaginal pain  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Cough  1  6/341 (1.76%)  6 7/346 (2.02%)  7 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Epistaxis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Grunting  1  0/341 (0.00%)  0 0/346 (0.00%)  0 1/341 (0.29%)  1 0/346 (0.00%)  0 0/608 (0.00%)  0
Nasal congestion  1  3/341 (0.88%)  3 4/346 (1.16%)  4 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Nasal obstruction  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Oropharyngeal pain  1  13/341 (3.81%)  13 13/346 (3.76%)  13 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Respiratory distress  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Rhinitis allergic  1  0/341 (0.00%)  0 3/346 (0.87%)  3 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Rhinorrhoea  1  2/341 (0.59%)  2 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Sinus congestion  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Throat irritation  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Transient tachypnoea of the newborn  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 2/346 (0.58%)  2 0/608 (0.00%)  0
Upper-airway cough syndrome  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia areata  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Dermatitis  1  1/341 (0.29%)  1 2/346 (0.58%)  2 4/341 (1.17%)  4 1/346 (0.29%)  1 0/608 (0.00%)  0
Dermatitis contact  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Erythema  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 1/346 (0.29%)  1 0/608 (0.00%)  0
Hyperhidrosis  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Ingrowing nail  1  0/341 (0.00%)  0 0/346 (0.00%)  0 0/341 (0.00%)  0 2/346 (0.58%)  2 0/608 (0.00%)  0
Night sweats  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pruritus  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Pruritus generalised  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Rash  1  1/341 (0.29%)  1 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Urticaria  1  2/341 (0.59%)  2 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Vascular disorders           
Hot flush  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hypertension  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Hypotension  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Phlebitis  1  1/341 (0.29%)  1 2/346 (0.58%)  2 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Raynaud's phenomenon  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Thrombosis  1  1/341 (0.29%)  1 0/346 (0.00%)  0 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
Varicose vein  1  0/341 (0.00%)  0 1/346 (0.29%)  1 0/341 (0.00%)  0 0/346 (0.00%)  0 0/608 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
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
EMail: en736091@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02377349    
Other Study ID Numbers: 116945
2014-001119-38 ( EudraCT Number )
First Submitted: February 26, 2015
First Posted: March 3, 2015
Results First Submitted: August 10, 2018
Results First Posted: January 28, 2019
Last Update Posted: January 28, 2020