Adults 18 to 45, female only, with Diphtheria-Tetanus-acellular Pertussis Vaccines. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Antibody Concentrations Against Pertussis Toxoid Antigen (Anti-PT), Filamentous Haemagglutinin Antigen (Anti-FHA) and Pertactin Antigen (Anti-PRN) in Cord Blood SamplesPrimary· At delivery - Visit 3 (anytime after 28 weeks of gestation)
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.
Anti-PT
Group
Value
95% CI
dTpa Group - Mother
46.9
41.2 – 53.3
Control Group - Mother
5.5
4.8 – 6.3
Anti-FHA
Group
Value
95% CI
dTpa Group - Mother
366.1
329 – 407.3
Control Group - Mother
22.7
19.7 – 26.2
Anti-PRN
Group
Value
95% CI
dTpa Group - Mother
301.8
250.9 – 362.9
Control Group - Mother
14.6
12.1 – 17.7
Percentage of Subjects by Pregnancy OutcomesSecondary· From Day 0 (Visit 1) to Month 2 (Visit 4, end of the study).
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.
Live infant No apparent congenital anomaly
Group
Value
95% CI
dTpa Group - Mother
97.4
95 – 98.8
Control Group - Mother
97.4
95.1 – 98.8
Live infant congenital anomaly
Group
Value
95% CI
dTpa Group - Mother
2.6
1.2 – 5
Control Group - Mother
2.3
1 – 4.5
Lost to follow-up
Group
Value
95% CI
dTpa Group - Mother
0
0 – 1.1
Control Group - Mother
0.3
0 – 1.6
Percentage of Subjects With Listed Pregnancy/Neonate Related Adverse Events of InterestSecondary· From Day 0 (Visit 1) to Month 2 post-delivery (Visit 4, end of the study).
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.
Percentage of Seroprotected Subjects Against Diphteria Antigen (Anti-D), Tetanus Antigen (Anti-T) and of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRNSecondary· One month post vaccination (Day 30) during pregnancy
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.
Anti-D
Group
Value
95% CI
dTpa Group - Mother
97.6
95.1 – 99
Control Group - Mother
70.6
65 – 75.8
Anti-T
Group
Value
95% CI
dTpa Group - Mother
100
98.7 – 100
Control Group - Mother
96.6
93.8 – 98.3
Anti-PT
Group
Value
95% CI
dTpa Group - Mother
98.6
96.5 – 99.6
Control Group - Mother
61.3
55.5 – 66.9
Anti-FHA
Group
Value
95% CI
dTpa Group - Mother
100
98.7 – 100
Control Group - Mother
94.5
91.2 – 96.8
Anti-PRN
Group
Value
95% CI
dTpa Group - Mother
100
98.7 – 100
Control Group - Mother
84.5
79.9 – 88.5
Anti-D, Anti-T, Anti-PT, Anti-FHA and Anti-PRN Antibody ConcentrationsSecondary· One month post vaccination (Day 30) during pregnancy
Antibody concentrations were determined by ELISA, tabulated as GMCs and expressed in IU/mL.
Anti-D
Group
Value
95% CI
dTpa Group - Mother
2.19
1.87 – 2.57
Control Group - Mother
0.23
0.19 – 0.27
Anti-T
Group
Value
95% CI
dTpa Group - Mother
8.43
7.72 – 9.2
Control Group - Mother
0.98
0.86 – 1.11
Anti-PT
Group
Value
95% CI
dTpa Group - Mother
45.6
40.4 – 51.5
Control Group - Mother
4.1
3.6 – 4.6
Anti-FHA
Group
Value
95% CI
dTpa Group - Mother
317.5
285 – 353.8
Control Group - Mother
15
13.1 – 17.2
Anti-PRN
Group
Value
95% CI
dTpa Group - Mother
283.6
237.1 – 339.1
Control Group - Mother
10.5
8.7 – 12.5
Percentage of Subjects With Vaccine Response to Anti-D and Anti-TSecondary· One month post vaccination (Day 30) during pregnancy
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.
Anti-D, S-
Group
Value
95% CI
dTpa Group - Mother
64.1
54 – 73.3
Control Group - Mother
0
0 – 4.3
Anti-D, S+
Group
Value
95% CI
dTpa Group - Mother
75
68.1 – 81.1
Control Group - Mother
0
0 – 1.8
Anti-D, Total
Group
Value
95% CI
dTpa Group - Mother
71.1
65.5 – 76.3
Control Group - Mother
0
0 – 1.3
Anti-T, S-
Group
Value
95% CI
dTpa Group - Mother
100
73.5 – 100
Control Group - Mother
0
0 – 30.8
Anti-T, S+
Group
Value
95% CI
dTpa Group - Mother
67.8
61.9 – 73.2
Control Group - Mother
0
0 – 1.3
Anti-T, Total
Group
Value
95% CI
dTpa Group - Mother
69.1
63.4 – 74.4
Control Group - Mother
0
0 – 1.3
Percentage of Subjects With Vaccine Response to Anti-PT, Anti-FHA and Anti-PRNSecondary· One month post vaccination (Day 30) during pregnancy
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 a
Anti-PT, S-
Group
Value
95% CI
dTpa Group - Mother
82.6
74.7 – 88.9
Control Group - Mother
0.9
0 – 5.1
Anti-PT, S+ (<4 cut-off)
Group
Value
95% CI
dTpa Group - Mother
90.7
83.6 – 95.5
Control Group - Mother
0
0 – 3.1
Anti-PT, S+ (≥4 cut-off)
Group
Value
95% CI
dTpa Group - Mother
93.1
83.3 – 98.1
Control Group - Mother
3
0.4 – 10.4
Anti-PT, Total
Group
Value
95% CI
dTpa Group - Mother
87.8
83.4 – 91.4
Control Group - Mother
1
0.2 – 3
Anti-FHA, S-
Group
Value
95% CI
dTpa Group - Mother
100
79.4 – 100
Control Group - Mother
0
0 – 20.6
Anti-FHA, S+ (<4 cut-off)
Group
Value
95% CI
dTpa Group - Mother
100
95.7 – 100
Control Group - Mother
0
0 – 5.5
Anti-FHA, S+ (≥4 cut-off)
Group
Value
95% CI
dTpa Group - Mother
89.9
84.7 – 93.8
Control Group - Mother
1.9
0.5 – 4.8
Anti-FHA, Total
Group
Value
95% CI
dTpa Group - Mother
93.4
89.9 – 96
Control Group - Mother
1.4
0.4 – 3.5
Percentage of Seropositive Subjects Against Anti-PT, Anti-FHA and Anti-PRN in the Cord Blood SamplesSecondary· At delivery - Visit 3 (anytime after 27 eligible weeks of gestation)
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.
Anti-PT
Group
Value
95% CI
dTpa Group - Mother
98.6
96.5 – 99.6
Control Group - Mother
68.8
63.2 – 74.1
Anti-FHA
Group
Value
95% CI
dTpa Group - Mother
100
98.7 – 100
Control Group - Mother
96.6
93.8 – 98.3
Anti-PRN
Group
Value
95% CI
dTpa Group - Mother
99.7
98.1 – 100
Control Group - Mother
88
83.7 – 91.5
Percentage of Subjects With Solicited Local Adverse Events (AEs)Secondary· During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
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.
Any Pain, Dose 1
Group
Value
95% CI
dTpa Group - Mother
86.3
82.1 – 89.8
Control Group - Mother
14.6
11 – 18.8
Any Redness (mm), Dose 1
Group
Value
95% CI
dTpa Group - Mother
28.7
23.9 – 33.8
Control Group - Mother
12.8
9.5 – 16.8
Any Swelling (mm), Dose 1
Group
Value
95% CI
dTpa Group - Mother
25.1
20.5 – 30.1
Control Group - Mother
3.5
1.8 – 6
Any Pain, Dose 2
Group
Value
95% CI
dTpa Group - Mother
12.7
9.2 – 16.8
Control Group - Mother
62.7
57.3 – 68
Any Redness (mm), Dose 2
Group
Value
95% CI
dTpa Group - Mother
10.5
7.4 – 14.4
Control Group - Mother
29.7
24.8 – 34.9
Any Swelling (mm), Dose 2
Group
Value
95% CI
dTpa Group - Mother
5.2
3.1 – 8.3
Control Group - Mother
26.4
21.7 – 31.5
Percentage of Subjects With Solicited General AEsSecondary· During the 8-day (Day 0-Day 7) follow-up period after vaccination during pregnancy
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.
Any Fatigue, Dose 1
Group
Value
95% CI
dTpa Group - Mother
43.6
38.2 – 49.1
Control Group - Mother
36.3
31.2 – 41.6
Any Gastrointestinal symptom, Dose 1
Group
Value
95% CI
dTpa Group - Mother
17.9
14 – 22.4
Control Group - Mother
15.2
11.6 – 19.5
Any Headache, Dose 1
Group
Value
95% CI
dTpa Group - Mother
24.8
20.2 – 29.8
Control Group - Mother
22.8
18.5 – 27.6
Any Temperature/(Axillary) (°C), Dose 1
Group
Value
95% CI
dTpa Group - Mother
1.2
0.3 – 3
Control Group - Mother
0.9
0.2 – 2.5
Any Fatigue, Dose 2
Group
Value
95% CI
dTpa Group - Mother
40.1
34.7 – 45.7
Control Group - Mother
46.2
40.8 – 51.8
Any Gastrointestinal symptom, Dose 2
Group
Value
95% CI
dTpa Group - Mother
9.9
6.9 – 13.7
Control Group - Mother
12.7
9.3 – 16.8
Any Headache, Dose 2
Group
Value
95% CI
dTpa Group - Mother
23.1
18.7 – 28.1
Control Group - Mother
23.6
19.1 – 28.5
Any Temperature/(Axillary) (°C), Dose 2
Group
Value
95% CI
dTpa Group - Mother
4.6
2.6 – 7.5
Control Group - Mother
9.1
6.2 – 12.7
Percentage of Subjects With Unsolicited AEsSecondary· Within 31 days (Day 0 - Day 30) after each vaccination
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.
Any unsolicited AE, Dose 1
Group
Value
95% CI
dTpa Group - Mother
38.7
33.5 – 44.1
Control Group - Mother
35.5
30.5 – 40.8
Any unsolicited AE, Dose 2
Group
Value
95% CI
dTpa Group - Mother
30.7
25.8 – 35.9
Control Group - Mother
32.2
27.2 – 37.4
Percentage of Infants With Unsolicited AEsSecondary· From delivery to Month 2 post delivery (Visit 4, end of the study).
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.
Group
Value
95% CI
dTpa Group - Infant
26.4
21.8 – 31.4
Control Group - Infnat
22.3
18.0 – 27.0
Adverse events — posted to ClinicalTrials.gov
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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
dTpa Group-Mother
Serious: 51/341 (15%)
Deaths: 0/341
Control Group-Mother
Serious: 52/346 (15%)
Deaths: 0/346
dTpa Group - Infant
Serious: 52/341 (15%)
Deaths: 0/341
Control Group-Infant
Serious: 45/346 (13%)
Deaths: 0/346
Household Group
Serious: 0/608 (0%)
Deaths: 0/608
Serious adverse events (93 terms)
Reaction
System
dTpa Group-Mother
Control Group-Mother
dTpa Group - Infant
Control Group-Infant
Household Group
Premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Premature baby
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Premature labour
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Jaundice
Hepatobiliary disorders
—
—
—
—
—
Postpartum haemorrhage
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Pre-eclampsia
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Preterm premature rupture of membranes
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Respiratory distress
Respiratory, thoracic and mediastinal disorders
—
—
—
—
—
Gestational hypertension
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Premature delivery
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Cryptorchism
Congenital, familial and genetic disorders
—
—
—
—
—
Hyperbilirubinaemia
Hepatobiliary disorders
—
—
—
—
—
Bronchiolitis
Infections and infestations
—
—
—
—
—
Foetal growth restriction
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Small for dates baby
Pregnancy, puerperium and perinatal conditions
—
—
—
—
—
Polydactyly
Congenital, familial and genetic disorders
—
—
—
—
—
Vomiting
Gastrointestinal disorders
—
—
—
—
—
Amniotic cavity infection
Infections and infestations
—
—
—
—
—
Endometritis decidual
Infections and infestations
—
—
—
—
—
Gastroenteritis
Infections and infestations
—
—
—
—
—
Neonatal infection
Infections and infestations
—
—
—
—
—
Respiratory syncytial virus bronchiolitis
Infections and infestations
—
—
—
—
—
Sepsis neonatal
Infections and infestations
—
—
—
—
—
Urinary tract infection
Infections and infestations
—
—
—
—
—
Dehydration
Metabolism and nutrition disorders
—
—
—
—
—
Other adverse events (213 terms — click to expand)
The purpose of this study is to assess the immunogenicity and safety of Boostrix™ when compared to a placebo given during 27-36 weeks of gestation in healthy women aged 18-45 years. Infants born to mothers enrolled in this study will be followed-up in two separate clinical studies: 201330 \[DTPA (BOOSTRIX)-048 PRI\] and 201334 \[DTPA (BOOSTRIX)-049 BST: 048\].
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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NCT01147900 — Evaluation of Boostrix™10 Years After Previous Booster Vaccination
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NCT00548171 — Immunogenicity & Reactogenicity of Boostrix 10 Years After Previous Booster Vaccination in Study NCT01267058
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· completed
NCT00346073 — Safety and Immunogenicity of GSK's Tdap Vaccine (Boostrix) in Adults Aged 19 to 64 Years
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 28 January 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02377349.