Whooping CoughNCT03973905

Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States

An observational study of Whooping Cough, run by GlaxoSmithKline at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States. Read more about this study

Who is it for?: Ages 2 days to 2 monthsHealthy volunteers can take part
Conditions the study is for: Whooping Cough
What is being tested?: Not applicable / dataset analysis
Type of treatment: Vaccines
How many people: 290 participants
Where: 1 siteBelgium
Study dates: 15 Feb 2019to 15 May 2019
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 days to 2 months
All sexes
Healthy volunteers accepted
Child

Study population: Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.

Who may be able to join

Case infants were eligible for the enrolment if they:
were at least 2 days old and < 2 months old on the cough onset date
resided in the catchment area on their cough onset date
were born in a hospital in their state of residence
were ≥37 weeks' gestational age at birth
were neither adopted nor in foster care

Show all 15Show fewer

did not live in a residential care facility
Control infants were eligible for the enrolment if they:
were at least 2 days old and <2 months old on the case infant's cough onset date
were born in a hospital in their state of residence
were ≥37 weeks' gestational age at birth
were neither adopted nor in foster care
did not live in a residential care facility
were born at the same hospital as the case infant
did not have pertussis diagnosis prior to the cough onset date of the corresponding case infant

Who cannot join

Infants (case and controls) whose mothers have received Adacel or mothers without brand information available, as well as controls who were matched to a case whose mother received Adacel or mothers without brand information available, will be excluded from the analysis of the effectiveness of vaccination with Boostrix.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

GSK Investigational Site
Wavre, 1300

Other trials in Belgium

About this study

Official title: Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States: Analysis of a Dataset From a Case-control Study

The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.

Conditions: Whooping Cough
Being tested: Not applicable / dataset analysis
Keywords: Whooping Cough, Boostrix, Tdap, effectiveness, pregnancy, infants
Medical subject headings: Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Not applicable / dataset analysisOther
Not applicable / dataset analysis

Study groups in NCT03973905
Study group	Role	What they receive
Pertussis Case Group		Infant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility). This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa. Receives: Other: Not applicable / dataset analysis
Control Group		Infant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant). This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa. Receives: Other: Not applicable / dataset analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during the third pregnancy trimester in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.
Measured: During the data collection period (from 1 January 2011 to 31 December 2014)

Secondary outcomes (3)

Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (Before Pregnancy, During First or Second Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second pregnancy trimester, after pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.
Measured: During the data collection period (from 1 January 2011 to 31 December 2014)
Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During First, Second or Third Trimester) or Not Exposed to Any Tdap Vaccine During Pregnancy
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.
Measured: During the data collection period (from 1 January 2011 to 31 December 2014)
Number of Pertussis Cases Leading to Hospitalization and Matched Controls in Infants Born to Mothers Vaccinated With Boostrix (Before Pregnancy, During First or Second, Third Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Vaccine effectiveness at preventing pertussis occurrence leading to hospitalization in infants < 2 months old is assessed by comparing the Boostrix immunization status before pregnancy, during first or second, third trimester, after pregnancy in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.
Measured: During the data collection period (from 1 January 2011 to 31 December 2014)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 201915 May 2019

First posted4 Jun 2019
Study start15 Feb 2019
Primary completion15 May 2019
Study completion15 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Whooping CoughStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03973905
Sponsor's protocol ID: 210031
Status last verified: Jul 2020
First submitted: 13 Feb 2019
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.
PubMed 29028938

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

All Whooping Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Maternal Immunization With Boostrix at Preventing Pertussis Among Infants <2 Months Old in the United States: Analysis of a Dataset From a Case-control Study
ClinicalTrials.gov ID: NCT03973905
Acronym / sponsor ID: 210031
Conditions: Whooping Cough
Keywords: Whooping Cough, Boostrix, Tdap, effectiveness, pregnancy, infants
Study type: Observational
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Feb 2019 (actual)
Primary completion: 15 May 2019 (actual)
Study completion: 15 May 2019 (actual)
First posted: 4 Jun 2019 (actual)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to estimate the effectiveness of maternal immunization with Boostrix at preventing pertussis in infants in the United States.

Study design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Pertussis Case Group	–	Other: Not applicable / dataset analysisInfant subjects of at least 2 days old and less than (<) 2 months old, who met the pertussis diagnosis definition (laboratory confirmed pertussis, epidemiological linkage to a laboratory-confirmed case, clinically compatible illness), and who met the case infants inclusion criteria (resided in the catchment area on their cough onset date, were born in a hospital in their state of residence, had at least 37 weeks gestational age at birth, were neither adopted, nor in foster care and did not live in a residential care facility). This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.
Control Group	–	Other: Not applicable / dataset analysisInfant subjects of at least 2 days old and less than (<) 2 months old, who did not have a pertussis diagnosis prior to the cough onset date and who met the inclusion criteria for control infants (were born on a hospital in their state of residence, were at least 37 weeks gestational age at birth, were neither adopted, nor in foster care, did not live in a residential care facility, were born at the same hospital as the case infant). This post-hoc analysis was limited to cases and controls whose mothers were either vaccinated with Boostrix or did not receive any Tdap vaccine. Cases with no remaining matched control were also excluded from the analysis and vice versa.

Who may qualify

Ages: 2 days to 2 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Infant subjects, born to mothers exposed, or unexposed to Boostrix or any Tdap vaccination, coming from 6 emerging program network sites.

Key inclusion criteria (15 listed)

Case infants were eligible for the enrolment if they:
were at least 2 days old and < 2 months old on the cough onset date
resided in the catchment area on their cough onset date
were born in a hospital in their state of residence
were ≥37 weeks' gestational age at birth

Key exclusion criteria (1 listed)

Infants (case and controls) whose mothers have received Adacel or mothers without brand information available, as well as controls who were matched to a case whose mother received Adacel or mothers without brand information available, will be excluded from the analysis of the effectiveness of vaccination with Boostrix.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Not applicable / dataset analysisNot applicable / dataset analysis	Other	Control Group, Pertussis Case Group

Primary outcome

Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)
Vaccine effectiveness at preventing pertussis occurrence in infants < 2 months old is assessed by comparing the Boostrix immunization status during the third pregnancy trimester in mothers of infant pertussis cases and matched controls. The association between maternal Boostrix vaccination and pertussis in infants was analyzed using conditional logistic regression. The multivariate analysis was performed to obtain the adjusted values. Covariates that were statistically significant in the univariate analysis or considered as clinically significant were included in the multivariable conditional logistic regression model. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.

3 secondary outcomes

Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (Before Pregnancy, During First or Second Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)
Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During First, Second or Third Trimester) or Not Exposed to Any Tdap Vaccine During Pregnancy
Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)
Number of Pertussis Cases Leading to Hospitalization and Matched Controls in Infants Born to Mothers Vaccinated With Boostrix (Before Pregnancy, During First or Second, Third Trimester, After Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy
Time frame: During the data collection period (from 1 January 2011 to 31 December 2014)

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pertussis Case Group	107	107
Control Group	183	183

Primary outcome: Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy

Time frame: During the data collection period (from 1 January 2011 to 31 December 2014). Count of participants. Unit: Participants

Measure	Pertussis Case Group n = 106	Control Group n = 180
Unvaccinated	72	112
Vaccinated during third trimester	5	17

Pertussis Case Group vs Control Group: Vaccine Effectiveness: 65.26 (95% CI -64.93 to 92.68)

Population analysed: The analysis includes cases and at least one matched control born from mothers either unvaccinated or vaccinated with Boostrix. Subjects with missing or unknown values, if any, for at least one of the risk factors were excluded from the model.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pertussis Case Group	0 of 0	0 of 0	0
Control Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Due to the specificities of this project, developing both protocol and statistical analysis plan would have been redundant and of no added value. GSK therefore described the planned analysis in a detailed statistical analysis plan.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29028938Skoff TH, Blain AE, Watt J, Scherzinger K, McMahon M, Zansky SM, Kudish K, Cieslak PR, Lewis M, Shang N, Martin SW. Impact of the US Maternal Tetanus, Diphtheria, and Acellular Pertussis Vaccination Program on Preventing Pertussis in Infants <2 Months of Age: A Case-Control Evaluation. Clin Infect Dis. 2017 Nov 29;65(12):1977-1983. doi: 10.1093/cid/cix724.
Individual participant dataSharing planned: No

Related trials for Whooping Cough

RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Whooping Cough, run by GlaxoSmithKline at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Pertussis Cases and Matched Controls Among Infants Born to Mothers Vaccinated With Boostrix Vaccine (During Third Trimester of Pregnancy) or Not Exposed to Any Tdap Vaccine During Pregnancy (time frame: During the data collection period (from 1 January 2011 to 31 December 2014)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03973905, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.