DiphtheriaPhase 4NCT02853929
Evaluation of Immunogenicity and Safety of a Booster Dose 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 in people with Diphtheria and Hepatitis B, run by GlaxoSmithKline at 29 sites in 6 countries.
Trial summary
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. Read more about this study
- Who is it for?
- Ages 9 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Hepatitis B, Acellular Pertussis
- What is being tested?
- Infanrix hexa
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 551 participants
- Where
- 29 sitesin 6 countries
- Study dates
- 19 Sep 2016to 19 Mar 2019
- 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 9 to 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects' parent(s)/Legally acceptable representatives (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 child 9 months of age at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and having completed their primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048 PRI].
Who cannot join
- Child in care
- Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster 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).
- A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunization 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 immunization 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 Product Information (PI) and according to the local governmental recommendations and provided a written approval of the Sponsor is obtained.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Major congenital defects.
- Serious chronic illness.
- Administration of immunoglobulins and/or any blood products during the period within three months before the booster dose of study vaccines or planned administration during the study period.
- Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination with Infanrix hexa and generally consisting of major alterations in consciousness, unresponsiveness, generalised or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
- History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
- Previous booster vaccination against Hib, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines (e.g: antigen, excipients).
- Hypersensitivity to latex.
- History of any neurological disorders or seizures.
- Any condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Acute disease and/or fever at the time of vaccination.
- Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on 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.
Trial locations and contacts
29 sites in 6 countries.
29 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
Italy4 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
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 a Booster Dose of GSK Biologicals' 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 assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis
- Being tested
- Infanrix hexa
- Keywords
- Pertussis, Immunogenicity, Poliomyelitis, Tetanus, Hepatitis B, Diptheria
- Medical subject headings
- Diphtheria, Hepatitis B, Haemophilus Infections, Tetanus, Poliomyelitis, Whooping Cough
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 co-administered with Prevenar13 as a booster dose.
| Study group | Role | What they receive |
|---|---|---|
| dTpa Group | Experimental | This group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure Receives: Biological: Infanrix hexa |
| Control Group | Active comparator | This group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure Receives: Biological: Infanrix hexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection.
0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection.
Measured: At one month after the booster dose (Day 30)
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))
Booster response to PT, FHA and PRN antigens was defined as:
- for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody 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, 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, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration
Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off.
Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination.
Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN
Measured: At one month after the booster dose (Day 30)
Secondary outcomes (15)
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP.
Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection.
0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection.
Measured: Before the booster dose (Day 0)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.
Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN
Measured: Before the booster dose (Day 0)
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.
Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively.
Measured: Before the booster dose (Day 0)
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL.
Measured: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-poliovirus Type 1, 2, 3 Antibody Titres
Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT).
Measured: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-HBs Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL.
Measured: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations
Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL.
Measured: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off.
Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN
Measured: At one month after the booster dose (Day 30)
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness, swelling. Any redness, swelling is defined as a symptom with a surface diameter greater than 0 millimeter
Measured: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were Drowsiness, Fever, Irritability/Fussiness and Loss of appetite.
Fever was defined as temperature ≥37.5 degree Celsius (°C) /99.5 degree Fahrenheit (°F) for oral, axillary or tympanic route, or ≥38.0°C/100.4°F on rectal route.
Measured: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, resulting in disability/incapacity
Measured: From booster dose up to study end (approximately 6 or 7 months, per subject)
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone
Neurodevelopmental status was measured by ASQ-3 score scale [ASQ-3, 2016] in the black zone. The ASQ-3 included a series of questions designed to assess 5 areas of development (communication, gross motor, fine motor, problem solving, and personal-social). Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was to be referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III [BSID-III])
Measured: At 9 months of age, 18 months of age, and 9 or 18 months of age
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)
Any subject who scored below the cut-off i.e., a score more than 2 Standard Deviations (SDs) below the mean score for the U.S. reference group (i.e., black zone in the score chart) in any of the 5 domains of the ASQ-3 was referred to a developmental specialist for a formal neurodevelopmental assessment (using the Bayley Scale for Infant Development, Version III BSID-III)
Measured: At 9 months of age, 18 months of age, and 9 or 18 months of age
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)
The estimated proportion (expressed in percentage) of infants with a BSID-III indicator of neurodevelopmental delay was based on ASQ-3 black zone indicator and subsequent BSID-III assessment using the following formula: 100 * (Number of subjects with ASQ-3 below cut off / Number of enrolled subjects with available results) * (Number of subjects with at least one indicator of neurodevelopmental delay using BSID III / Number of subjects referred for BSID III evaluation)
Measured: At 9 months of age, 18 months of age, and 9 or 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study start19 Sep 2016
- Primary completion19 Mar 2019
- Study completion19 Mar 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 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 551 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
- NCT02853929
- Sponsor's protocol ID
- 201334
- Other IDs
- 2014-001120-30, 2014
- Status last verified
- Dec 2019
- First submitted
- 14 Jul 2016
- Last updated
- 14 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Martinon-Torres F, Halperin SA, Nolan T, Tapiero B, Perrett KP, de la Cueva IS, Garcia-Sicilia J, Stranak Z, Vanderkooi OG, Kosina P, Rumlarova S, Virta M, Arribas JMM, Miranda-Valdivieso M, Novas BA, Bozensky J, Ortega MJC, Amador JTR, Baca M, Palomino EE, Zuccotti GV, Janota J, Marchisio PG, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Mesaros N. Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial. Vaccine. 2021 Mar 12;39(11):1598-1608. doi: 10.1016/j.vaccine.2021.02.001. Epub 2021 Feb 19.
PubMed 33612341
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of a Booster Dose of GSK Biologicals' Infanrix Hexa™ (217744) in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
- ClinicalTrials.gov ID
- NCT02853929
- Acronym / sponsor ID
- 201334
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis
- Keywords
- Pertussis, Immunogenicity, Poliomyelitis, Tetanus, Hepatitis B, Diptheria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 551 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 19 Mar 2019 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 3 Aug 2016 (estimated)
- Results
- Posted 14 Jan 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 assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.
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 hexaThis group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a single dose of Boostrix during pregnancy and a dose of placebo immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure |
| Control Group | Active comparator | Biological: Infanrix hexaThis group will consist of healthy male or female infants, aged 9 months at the time of enrollment, born to mothers who received a dose of placebo during pregnancy and single dose of Boostrix immediately post-delivery. All enrolled subjects in this group who will come back for subsequent visit will receive a booster dose of Infanrix hexa co-administered with Prevenar 13 according to the routine national/local immunization or study procedure |
Who may qualify
- Ages
- 9 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects' parent(s)/Legally acceptable representatives (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 child 9 months of age at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and having completed their primary vaccination series as per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048 PRI].
Key exclusion criteria (20 listed)
- Child in care
- Concurrently participating in another clinical study, within three months prior to the booster vaccine dose and at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period within six months prior to the booster 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).
- A vaccine not foreseen by the study protocol administered during the period starting from 30 days before the booster dose of study vaccine and ending 30 days after*, with the exception of inactivated influenza vaccine and other vaccines given as a part of the national/regional immunization 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 hexaAll subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose. | Biological | Control Group, dTpa Group |
Primary outcome
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
Time frame: At one month after the booster dose (Day 30)
Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection.
Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN))
Time frame: At one month after the booster dose (Day 30)
Booster response to PT, FHA and PRN antigens was defined as: * for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody 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, 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, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN
15 secondary outcomes
Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP.
Time frame: Before the booster dose (Day 0)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Time frame: Before the booster dose (Day 0)
Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F)
Time frame: Before the booster dose (Day 0)
Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-poliovirus Type 1, 2, 3 Antibody Titres
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-HBs Antibody Concentrations
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations
Time frame: Before the booster dose (Day 0) and One month after the booster dose (Day 30)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At one month after the booster dose (Day 30)
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination of two vaccines (Infanrix hexa and Prevenar 13)
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From booster dose up to study end (approximately 6 or 7 months, per subject)
Number of Subjects With an ASQ-3 Score (Ages & Stages Questionnaires, Third Edition) in the Black Zone
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Number of Subjects Referred for Formal Neurodevelopmental Evaluation Using BSID-III (Bayley Scale for Infant Development, Version III)
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Estimated Proportion of Infants With at Least One of the Indicators of Neurodevelopmental Impairment Using BSID-III (Bayley Scale for Infant Development, Version III)
Time frame: At 9 months of age, 18 months of age, and 9 or 18 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33612341Martinon-Torres F, Halperin SA, Nolan T, Tapiero B, Perrett KP, de la Cueva IS, Garcia-Sicilia J, Stranak Z, Vanderkooi OG, Kosina P, Rumlarova S, Virta M, Arribas JMM, Miranda-Valdivieso M, Novas BA, Bozensky J, Ortega MJC, Amador JTR, Baca M, Palomino EE, Zuccotti GV, Janota J, Marchisio PG, Kostanyan L, Meyer N, Ceregido MA, Cheuvart B, Kuriyakose SO, Mesaros N. Impact of maternal diphtheria-tetanus-acellular pertussis vaccination on pertussis booster immune responses in toddlers: Follow-up of a randomized trial. Vaccine. 2021 Mar 12;39(11):1598-1608. doi: 10.1016/j.vaccine.2021.02.001. Epub 2021 Feb 19.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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
29 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 in people with Diphtheria and Hepatitis B, run by GlaxoSmithKline at 29 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 5 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 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 14 Jan 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 Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) (time frame: At one month after the booster dose (Day 30)). 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 NCT02853929, 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 14 Jan 2020; AzTrials last refreshed its copy on 8 Nov 2026.