Acellular PertussisPhase 4NCT02422264
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
A Phase 4 study testing Infanrix hexa and Prevnar13 in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 30 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. Read more about this study
- Who is it for?
- Ages 6 to 14 weeksHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Tetanus, Poliomyelitis
- What is being tested?
- Infanrix hexa and Prevnar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 30 sitesin 6 countries
- Study dates
- 22 Jan 2016to 7 Mar 2018
- Phase
- Phase 4
- 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 6 to 14 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
- Medically stable* prematurely born infants, born after a gestation period of 27-36 weeks may be enrolled in the study at the discretion of the investigator.
- Medically stable refers to the condition of premature infants who do not require significant medical support or ongoing management for debilitating disease and who have demonstrated a clinical course of sustained recovery by the time they receive the first dose of study vaccine.
Who cannot join
- Child in care
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- Administration of any chronic drug therapy to be continued during the study period.
- A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
- In case an emergency mass vaccination for an unforeseen public health threat (e.g.: a pandemic) is organised by the public health authorities, outside the routine immunisation program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its SPC or package insert (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
Show all 20Show fewer
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Previous vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, and/or poliovirus since birth.
- History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including severe combined immunodeficiency disease (SCID), based on medical history and physical examination (no laboratory testing required).
- Family history of congenital or hereditary immunodeficiency.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Major congenital defects
- Serious chronic illness.
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C/99.5°F for oral, axillary or tympanic route, or ≥38.0°C/100.4°F for rectal route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products during the period starting at birth before the first dose of study vaccines or planned administration during the study period.
- Hypersensitivity to latex.
Trial locations and contacts
30 sites in 6 countries.
30 sites in 6 countries
Spain11 sites
GSK Investigational Site
Antequera/Málaga, 29200
GSK Investigational Site
Aravaca, 28023
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Madrid, 28046
GSK Investigational Site
Madrid, 28050
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Málaga, Andalusia, 29004
GSK Investigational Site
Móstoles, 28938
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41014
Czechia5 sites
GSK Investigational Site
Brno, 613 00
GSK Investigational Site
Hradec Králové, 500 02
GSK Investigational Site
Ostrava - Vitkovice, 703 84
GSK Investigational Site
Prague, 140 59
GSK Investigational Site
Prague, 14700
Finland5 sites
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
Italy5 sites
GSK Investigational Site
Milan, Lombardy, 20122
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Milan, Lombardy, 20154
GSK Investigational Site
Novara, Piedmont, 28100
GSK Investigational Site
Turin, Piedmont, 10126
Canada3 sites
GSK Investigational Site
Calgary, Alberta, T3B 6A8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
Montreal, Quebec, H3T 1C5
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated Polio-virus and Haemophilus Influenzae Type b Vaccine (Infanrix Hexa™) (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
- Being tested
- Infanrix hexa, Prevnar13
- Medical subject headings
- Tetanus, Poliomyelitis, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix hexaBiological
- All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.
Prevnar13Drug
- All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
| Study group | Role | What they receive |
|---|---|---|
| dTpa Group | Experimental | This group will consist of infants born to mothers belonging to the dTpa Group in study 116945 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of BoostrixTM during pregnancy and a dose of placebo immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. Receives: Biological: Infanrix hexa; Drug: Prevnar13 |
| Control Group | Active comparator | This group will consist of infants born to mothers belonging to the Control group in study 116945 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of BoostrixTM immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. Receives: Biological: Infanrix hexa; Drug: Prevnar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
Measured: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
Measured: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
Measured: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.
Measured: 1 month after the last dose of the primary vaccination
Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
Measured: 1 month after the last dose of the primary vaccination
Secondary outcomes (15)
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
A seroprotected subject is a subject whose antibody concentration was ≥ the level defining clinical protection, of 0.1 IU/mL.
Measured: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Measured: Before the first dose of Infanrix hexa
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Measured: Before the first dose of Infanrix hexa
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT, anti-FHA and anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Measured: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in IU/mL.
Measured: 1 month after the last dose of the primary vaccination
Anti-Polio Type 1, 2 and 3 Antibody Titers
Anti-Polio type 1, 2 and 3 antibody titers were expressed as geometric mean titers (GMT).
Measured: 1 month after the last dose of the primary vaccination
Anti-HBs Antibody Concentrations
Anti-HBs antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL.
Measured: 1 month after the last dose of the primary vaccination
Anti-PRP Antibody Concentrations
Anti-PRP antibody concentrations were expressed as GMCs and measured in µg/mL.
Measured: 1 month after the last dose of the primary vaccination
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PT, anti-FHA, anti-PRN antibody concentrations were expressed as GMCs and measured in IU/mL.
Measured: 1 month after the last dose of the primary vaccination
Anti-pneumococcal Antibody Concentrations
Assessed anti-pneumococcal serotypes were (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), expressed as GMCs and measured in µg/mL.
Measured: 1 month after the last dose of the primary vaccination
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
A seropositive subject is a subject whose antibody concentration is ≥ the assay cut-off defined. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA,2.187 IU/mL for anti-PRN
Measured: 1 month after the last dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Solicited local symptoms were assessed by each and across dose.
Measured: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as axillary route temperature ≥ 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Solicited general symptoms were assessed by each and across dose.
Measured: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Unsolicited Adverse Events
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (days 0-30) follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start22 Jan 2016
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
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 Acellular PertussisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 601 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
- NCT02422264
- Sponsor's protocol ID
- 201330
- Other IDs
- 2014-001117-41, 2014
- Status last verified
- Jun 2019
- First submitted
- 19 Mar 2015
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Perrett KP, Halperin SA, Nolan T, Carmona Martinez A, Martinon-Torres F, Garcia-Sicilia J, Virta M, Vanderkooi OG, Zuccotti GV, Manzoni P, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Stranak Z, Merino Arribas JM, Cilleruelo Ortega MJ, Miranda-Valdivieso M, Arias Novas B, Ramos Amador JT, Omenaca F, Baca M, Marchisio PG, Mesaros N. Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2105-2114. doi: 10.1016/j.vaccine.2019.10.104. Epub 2019 Nov 24.
PubMed 31776027
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Combined Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated Polio-virus and Haemophilus Influenzae Type b Vaccine (Infanrix Hexa™) (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
- ClinicalTrials.gov ID
- NCT02422264
- Acronym / sponsor ID
- 201330
- Conditions
- Acellular Pertussis, Tetanus, Poliomyelitis, Diphtheria, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2016 (actual)
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- Results
- Posted 10 Jun 2019
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 evaluate the immunogenicity and safety of GSK Biologicals' Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if the presence of transplacentally transferred maternal antibodies interfere with the immune response to primary vaccination with Infanrix hexa and a co-administered pneumococcal conjugate vaccine given as a part of this study in infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dTpa Group | Experimental | Biological: Infanrix hexa, Drug: Prevnar13This group will consist of infants born to mothers belonging to the dTpa Group in study 116945 [DTPA (BOOSTRIX)-047] i.e. who received a single dose of BoostrixTM during pregnancy and a dose of placebo immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. |
| Control Group | Active comparator | Biological: Infanrix hexa, Drug: Prevnar13This group will consist of infants born to mothers belonging to the Control group in study 116945 [DTPA (BOOSTRIX)-047], i.e. who received a single dose of placebo during pregnancy and a dose of BoostrixTM immediately post-delivery. All infants in this group will receive Infanrix hexaTM co-administered with Prevenar 13®. |
Who may qualify
- Ages
- 6 to 14 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- A male or female between, 6 and 14 weeks of age (including 6 weeks and up to and including 14 weeks and 6 days of age) at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born to a mother enrolled in study 116945 [DTPA (BOOSTRIX)-047].
Key exclusion criteria (20 listed)
- Child in care
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting at birth prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- Administration of any chronic drug therapy to be continued during the study period.
- A vaccine not foreseen by the study protocol administered during the period starting from 30 days before each dose of vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunisation schedule, that are allowed at any time during the study period.
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 |
|---|---|---|
| Infanrix hexa• All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh. | Biological | Control Group, dTpa Group |
| Prevnar13• All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh. | Drug | Control Group, dTpa Group |
Primary outcome
Number of Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Time frame: 1 month after the last dose of the primary vaccination
Vaccine response to the PT, FHA and PRN antigens, is defined as the appearance of antibodies in subjects who were initially seronegative (i.e., with concentrations lower than (<) the cut-off value of the assay), or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e., with concentrations greater than or equal to (≥) the cut-off value of the assay). Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA, 2.187 IU/mL for anti-PRN.
Number of Seroprotected Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off
Time frame: 1 month after the last dose of the primary vaccination
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.1 International Units per milliliter (IU/mL).
Number of Seroprotected Subjects With Anti Hepatitis B (Anti-HBs) Antibody Concentration Above or Equal to the Assay Cut-off
Time frame: 1 month after the last dose of the primary vaccination
A seroprotected subject is a subject whose antibody concentration/titre was ≥ to the level defining clinical protection, of 10 micro International Units per milliliter (mIU/mL).
Number of Seroprotected Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentration Above or Equal to 8
Time frame: 1 month after the last dose of the primary vaccination
A seroprotected subject is a subject whose antibody titre was ≥ the level defining clinical protection, of 8 ED50.
Number of Seroprotected Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Above or Equal to the Assay Cut-off
Time frame: 1 month after the last dose of the primary vaccination
A seroprotected subject is a subject whose antibody concentration/titre was ≥ the level defining clinical protection, of 0.15 micrograms per milliliter (µg/mL).
15 secondary outcomes
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) Antibody Concentration Above or Equal to the Assay Cut-off.
Time frame: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Time frame: Before the first dose of Infanrix hexa
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
Time frame: Before the first dose of Infanrix hexa
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Before the first dose of Infanrix hexa
Anti-D and Anti-T Antibody Concentrations
Time frame: 1 month after the last dose of the primary vaccination
Anti-Polio Type 1, 2 and 3 Antibody Titers
Time frame: 1 month after the last dose of the primary vaccination
Anti-HBs Antibody Concentrations
Time frame: 1 month after the last dose of the primary vaccination
Anti-PRP Antibody Concentrations
Time frame: 1 month after the last dose of the primary vaccination
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Time frame: 1 month after the last dose of the primary vaccination
Anti-pneumococcal Antibody Concentrations
Time frame: 1 month after the last dose of the primary vaccination
Number of Subjects With Anti-PT, Anti-FHA, Anti-PRN Antibody Concentration Above or Equal to the Assay Cut-off.
Time frame: 1 month after the last dose of the primary vaccination
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Day 0-Day 3) follow-up period after each vaccination
Number of Subjects With Unsolicited Adverse Events
Time frame: During the 31-day (days 0-30) follow-up period after each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Day 0, prior to vaccination until the study end, at Month 3 or 5 (depending on vaccination schedule of the country)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31776027Perrett KP, Halperin SA, Nolan T, Carmona Martinez A, Martinon-Torres F, Garcia-Sicilia J, Virta M, Vanderkooi OG, Zuccotti GV, Manzoni P, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Stranak Z, Merino Arribas JM, Cilleruelo Ortega MJ, Miranda-Valdivieso M, Arias Novas B, Ramos Amador JT, Omenaca F, Baca M, Marchisio PG, Mesaros N. Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial. Vaccine. 2020 Feb 18;38(8):2105-2114. doi: 10.1016/j.vaccine.2019.10.104. Epub 2019 Nov 24.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Acellular Pertussis
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
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus
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
30 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infanrix hexa and Prevnar13 in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 30 sites in 6 countries.
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 7 inclusion and 20 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain, Czechia, Finland, Italy, Canada and 1 more country. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jun 2019). 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 Subjects With Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens (time frame: 1 month after the last dose of the primary vaccination). The study lists 5 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 NCT02422264, 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 9 Jul 2019.