Last updated: 02/21/2024 10:30:35

Boostrix safety and immunogenicity in adults using treatment for chronic respiratory disorders

GSK study ID
217998
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title:
Trial description: The aim of this study is to evaluate existing data from GSK-sponsored studies of vaccination with Tdap vaccine in adults in order to assess immunogenicity and safety in Tdap vaccinated patients while taking treatments for chronic respiratory disorders like asthma and chronic obstructive pulmonary disease (COPD).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Percentage of seroprotected patients with anti-diphtheria (anti-D) antibodies

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of seroprotected patients with anti-tetanus (anti-T) antibodies

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients with anti-pertussis toxoid (anti-PT) antibodies, pre- to post-vaccination Boostrix booster response

Timeframe: Pre- to post-vaccination Boostrix booster response [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients with anti-filamentous haemagglutinin (anti-FHA) antibodies pre- to post-vaccination Boostrix booster response

Timeframe: Pre- to post-vaccination Boostrix booster response [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients with anti-pertactin (anti-PRN) antibodies pre- to post-vaccination Boostrix booster response

Timeframe: Pre- to post-vaccination Boostrix booster response [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients reporting each solicited local adverse events (AEs)

Timeframe: During the 4-days (Day 0-3) follow-up period after Boostrix vaccination [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients reporting each general AEs

Timeframe: During the 4-days (Day 0-3) follow-up period after Boostrix vaccination [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Secondary outcomes:

Anti-D antibody concentrations

Timeframe: 1 month after the Boostrix vaccination dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Anti-T antibody concentrations

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Anti-PT antibody concentrations

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Anti-FHA antibody concentrations

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Anti-PRN antibody concentrations

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients seropositive for anti-PT antibodies

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients seropositive for anti-FHA antibodies

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients seropositive for anti-PRN antibodies

Timeframe: 1 month after the Boostrix vaccine dose [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients reporting unsolicited AEs

Timeframe: During the 31-day (Day 0-30) follow-up period after Boostrix vaccination [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Percentage of patients reporting serious adverse events (SAEs)

Timeframe: During the 31-day (Day 0-30) follow-up period after vaccination [administered in studies dTpa-002 (NCT01267058), Tdap0.3-007 (NCT00346073), Tdap0.3-008 (NCT00385255), Tdap0.3-011 (NCT00835237) and Zoster-042 (NCT02052596)

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2021-16-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
P. Van den Steen, B. Cheuvart, Q. Deraedt, L. Valdes Verelst, D. Sharamina. Immunogenicity and safety of reduced-antigen tetanus, diphtheria and acellular pertussis vaccination in adults treated for obstructive airway diseases. Hum Vaccin Immunother. 2023;e2159731-1-11. DOI: http://dx.doi.org/ https://doi.org/10.1080/21645515.2022.2159731
Medical condition
Respiratory Disorders
Product
SB263855
Collaborators
Not applicable
Study date(s)
November 2021 to December 2021
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18 Years - NA Not applicable (No limit)
Accepts healthy volunteers
Yes
  • Adult studies with Tdap or Tdap-IPV including at least a substantial portion of adults above 40 years of age
  • Follow-up studies or revaccination studies studying the same patients as the primary study.
  • Studies on pregnant women.
Inclusion and exclusion criteria
Inclusion criteria:
  • Adult studies with Tdap or Tdap-IPV including at least a substantial portion of adults above 40 years of age
Exclusion criteria:
  • Follow-up studies or revaccination studies studying the same patients as the primary study.
  • Studies on pregnant women.
  • Studies in which the number of patients using the treatment for obstructive airway diseases is below 15 patients.
  • The informed consent check does not allow for additional testing.
  • For the safety analysis: studies without Medical Dictionary for Regulatory Activities (MedDRA) coding will be excluded.
  • Regarding the study groups:
  • Only the study groups of vaccination with Tdap or Tdap-IPV will be considered.
  • For co-administration studies, only the Tdap administration group of the control arm will be included.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2021-16-12
Actual study completion date
2021-16-12

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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