DiphtheriaNCT02447978
Duration of Protection: GSK DTaP Vaccines
An observational study of Diphtheria and Acellular Pertussis, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis. Read more about this study
- Who is it for?
- Ages 47 months to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Acellular Pertussis, Tetanus
- What is being tested?
- Infanrix, Pediarix and Kinrix
- Type of treatment
- Vaccines
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 47 months to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.
Who may be able to join
- Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
- The 5th dose was given between the ages of 47 and 84 months.
- All 5 DTaP doses received were manufactured by GSK, depending on study objective (otherwise this criterion will not apply).
- Born in 1999 and later.
- All individuals meeting above inclusion criteria who tested PCR-positive for pertussis and negative for parapertussis during the study period.
- All individuals meeting above inclusion criteria who tested PCR-negative for both pertussis and parapertussis during the study period.
- All individuals from the general KPNC population meeting above inclusion criteria who match a PCR-positive case on sex, age, race or ethnic group, and medical center.
- KPNC members on the day their matched case under-went the PCR test (anchor date).
Who cannot join
- Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
- Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
- Individuals who received reduced antigen content pertussis vaccine (Tdap) or any pertussis-containing vaccine after their 5th DTaP dose but before their PCR test date (or anchor date).
- Individuals will be excluded from serving as a control once they test positive for pertussis.
About this study
Official title: Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
The purpose of this study is to assess duration of protection for GSK DTaP vaccines in preventing pertussis.
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Being tested
- Infanrix, Pediarix, Kinrix
- Medical subject headings
- Diphtheria, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfanrixBiological
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Indicated as a 5-dose series in infants and children 6 weeks to 7 years of age.
PediarixBiological
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Indicated as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).
KinrixBiological
Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
| Study group | Role | What they receive |
|---|---|---|
| PCR-positive pertussis cases | Cases will be all individuals who tested PCR-positive for pertussis and negative for parapertussis during the study period and who received 5 doses of DTaP vaccines (either manufactured by GSK or any brand, depending on study objective) through 84 months of age before testing PCR-positive. Receives: Biological: Infanrix; Biological: Pediarix; Biological: Kinrix | |
| PCR-negative pertussis controls | Controls will consist of persons who tested PCR-negative for both pertussis and parapertussis and who received 5 DTaP doses (either manufactured by GSK or any brand, depending on study objective) before testing PCR negative. Receives: Biological: Infanrix; Biological: Pediarix; Biological: Kinrix | |
| KPNC-matched controls | Controls will consist of all KPNC members of the same sex, age (year and quarter of birth), race or ethnic group (7 groups; 6 for reported, 1 for imputed), and medical centre as each pertussis case and who were members on the date the case tested PCR-positive (anchor date). Receives: Biological: Infanrix; Biological: Pediarix; Biological: Kinrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Measured: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Measured: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Secondary outcomes (2)
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Estimation derived from comparing PCR-positive cases and matched controls
Measured: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Estimation derived from comparing PCR-positive cases and matched controls
Measured: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies 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
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447978
- Sponsor's protocol ID
- 201477
- Status last verified
- Oct 2015
- First submitted
- 26 Mar 2015
- Last updated
- 2 Nov 2015
- Results posted
- No
Publications
Klein NP, Bartlett J, Fireman B, Aukes L, Buck PO, Krishnarajah G, Baxter R. Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 2017 Jun 8;35(26):3395-3400. doi: 10.1016/j.vaccine.2017.05.008. Epub 2017 May 12.
PubMed 28506516
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Protection Following Five Doses of GlaxoSmithKline's (GSK's) DTaP Vaccines in School Age Children
- ClinicalTrials.gov ID
- NCT02447978
- Acronym / sponsor ID
- 201477
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
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 assess duration of protection for GSK DTaP vaccines in preventing pertussis.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCR-positive pertussis cases | – | Biological: Infanrix, Biological: Pediarix, Biological: KinrixCases will be all individuals who tested PCR-positive for pertussis and negative for parapertussis during the study period and who received 5 doses of DTaP vaccines (either manufactured by GSK or any brand, depending on study objective) through 84 months of age before testing PCR-positive. |
| PCR-negative pertussis controls | – | Biological: Infanrix, Biological: Pediarix, Biological: KinrixControls will consist of persons who tested PCR-negative for both pertussis and parapertussis and who received 5 DTaP doses (either manufactured by GSK or any brand, depending on study objective) before testing PCR negative. |
| KPNC-matched controls | – | Biological: Infanrix, Biological: Pediarix, Biological: KinrixControls will consist of all KPNC members of the same sex, age (year and quarter of birth), race or ethnic group (7 groups; 6 for reported, 1 for imputed), and medical centre as each pertussis case and who were members on the date the case tested PCR-positive (anchor date). |
Who may qualify
- Ages
- 47 months to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines between ages 1 month and 84 months at KPNC.
Key inclusion criteria (8 listed)
- Kaiser Permanente Northern California (KPNC) member who received 5 doses of acellular pertussis vaccines be-tween ages 1 month and 84 months at KPNC.
- The 5th dose was given between the ages of 47 and 84 months.
- All 5 DTaP doses received were manufactured by GSK, depending on study objective (otherwise this criterion will not apply).
- Born in 1999 and later.
- All individuals meeting above inclusion criteria who tested PCR-positive for pertussis and negative for parapertussis during the study period.
Key exclusion criteria (4 listed)
- Individuals whose PCR test date (or anchor date) is less than 2 weeks after receiving their 5th DTaP dose.
- Individuals who were not KPNC members for greater than 3 months between their 5th DTaP dose and PCR test date (or anchor date).
- Individuals who received reduced antigen content pertussis vaccine (Tdap) or any pertussis-containing vaccine after their 5th DTaP dose but before their PCR test date (or anchor date).
- Individuals will be excluded from serving as a control once they test positive for pertussis.
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 |
|---|---|---|
| InfanrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Indicated as a 5-dose series in infants and children 6 weeks to 7 years of age. | Biological | KPNC-matched controls, PCR-negative pertussis controls, PCR-positive pertussis cases |
| PediarixDiphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Indicated as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday). | Biological | KPNC-matched controls, PCR-negative pertussis controls, PCR-positive pertussis cases |
| KinrixDiphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine | Biological | KPNC-matched controls, PCR-negative pertussis controls, PCR-positive pertussis cases |
Primary outcome
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Estimation done by comparing time since the 5th DTaP dose between PCR-positive cases and PCR-negative controls
2 secondary outcomes
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed)
Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine
Estimated DTaP (any brand) relative decrease in protection against pertussis disease (PCR-confirmed)
Time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (any brand) vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Derived from this study: PubMed 28506516Klein NP, Bartlett J, Fireman B, Aukes L, Buck PO, Krishnarajah G, Baxter R. Waning protection following 5 doses of a 3-component diphtheria, tetanus, and acellular pertussis vaccine. Vaccine. 2017 Jun 8;35(26):3395-3400. doi: 10.1016/j.vaccine.2017.05.008. Epub 2017 May 12.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria and Acellular Pertussis, run by GlaxoSmithKline.
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 8 inclusion and 4 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 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimated GSK-only DTaP relative decrease in protection against pertussis disease (PCR-confirmed) (time frame: Between 1 and 84 months of age of the subjects who received all 5 doses of DTaP (GSK-only) vaccine). The study lists 2 primary outcomes in all. 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 NCT02447978, 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 2 Nov 2015.