Acellular PertussisPhase 2NCT01453998
Safety and Immunogenicity of a Booster Dose of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
A Phase 2 study testing Infanrix hexa, Prevenar 13 and GSK217744 in people with Acellular Pertussis and Hepatitis B, run by GlaxoSmithKline at 16 sites in 2 countries.
Trial summary
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. Read more about this study
- Who is it for?
- Ages 12 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b
- What is being tested?
- Infanrix hexa, Prevenar 13 and GSK217744
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 657 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 14 Oct 2011to 12 Nov 2012
- Phase
- Phase 2
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 12 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who participated in the study 113948 (NCT01248884) and received three doses of the new or licensed DTPa-HBV-IPV/Hib study vaccine.
- A male or female child between, and including, 12 and 15 months of age at the time of the booster vaccination.
- Subjects who the investigator believes that parent(s)/ Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period.
- Participation in another clinical study within three months prior to enrolment in the present booster study or 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 product (pharmaceutical product or device).
- Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Hib vaccination or disease since the conclusion visit of study 113948 (NCT01248884).
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- Serious chronic illness.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the booster dose of study vaccine or planned administration during the study period.
- Occurrence of any of the following events following previous administration of the study vaccine constitutes an absolute contraindication to further dosing.
- Anaphylactic or other hypersensitivity reaction.
- Encephalopathy defined as an acute, severe central nervous system disorder occurring within 7 days following vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
- Temperature of ≥ 40.0°C (axillary) or 40.5°C (rectal) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0° on rectal setting.
- 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
16 sites in 2 countries.
16 sites in 2 countries
Finland14 sites
GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Kuopio, 70210
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
GSK Investigational Site
Vantaa, 01600
Dominican Republic2 sites
GSK Investigational Site
Santo Domingo
GSK Investigational Site
Santo Domingo, Distrito Nacional
About this study
The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the booster vaccine dose of 2 new formulations of DTPa-HBV-IPV/Hib administered between 12 and 15 months of age, and the immune persistence following the primary series. All children in this booster study received a primary vaccination at 2, 3 and 4 months of age in study 113948 (NCT01248884). No new subjects will be enrolled in this booster study.
- Conditions
- Acellular Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Tetanus, Diphtheria, Poliomyelitis
- Being tested
- Infanrix hexa, Prevenar 13, GSK217744
- Medical subject headings
- Hepatitis B, Haemophilus Infections, Tetanus, Diphtheria, Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix hexaBiological
Also called DTPa-HBV-IPV/Hib
Single dose, licensed formulation, intramuscular into right thigh
Prevenar 13Biological
Also called Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
Single co-administered dose, intramuscular into left thigh
GSK217744Biological
Single dose, investigational formulation A or B, intramuscular into right thigh
| Study group | Role | What they receive |
|---|---|---|
| GSK217744 Group 1 | Experimental | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. Receives: Biological: Infanrix hexa; Biological: Prevenar 13; Biological: GSK217744 |
| GSK217744 Group 2 | Experimental | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13. The Infanrix hexa/GSK217744 and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. Receives: Biological: Infanrix hexa; Biological: Prevenar 13; Biological: GSK217744 |
| Infanrix hexa Group | Active comparator | Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa vaccine in the primary study and a booster dose of Infanrix hexa in this study, co-administered with a booster dose of Prevenar 13. The Infanrix hexa and Prevenar 13 vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. Receives: Biological: Infanrix hexa; Biological: Prevenar 13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Types 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Measured: 1 month post booster vaccination (subjects enrolled after protocol amendment 2)
Secondary outcomes (42)
Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Measured: Before (PRE) and 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-D and Anti-T Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Measured: Before (PRE) 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-D and Anti-T Antibodies
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PT, Anti-FHA and Anti-PRN
Concentrations were expressed as geometric mean concentrations (GMCs). Seropositivity cut-off assay was 5 EL.U/mL.
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2))
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Measured: 1 month post booster vaccination (POST) ( subjects enrolled after protocol amendment 2)
Anti-Hepatitis B (Anti-HBs) Antibody Concentration
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Anti-HBs Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs). Seroprotection cut-off assay was 10 mIU/mL.
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Hepatitis B (Anti-HBs) Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was a subject whose antibody concentration was greater than or equal to the level defining clinical protection of 10 milli-international units per millilitre (mIU/mL).
Measured: Before (PRE) booaster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentration for Anti-poliovirus Types 1, 2, 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-poliovirus Types 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentration for Anti-poliovirus Type 1, 2 and 3
Concentrations were expressed as geometric mean titers (GMTs). The seroprotection cut-off of the assay was 8.
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects Against Anti-Poliovirus Type 1, 2 and 3
A seroprotected subject was a subject whose antibody titre was greater than or equal to the level defining clinical protection of 8.
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PRP Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Concentrations for Anti-polyribosyl-ribitol Phosphate Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.15 µg /mL.
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2))
Number of Seropositive Subjects for Anti-Pertussis Toxoid (Anti-PT), Anti-Filamentous Haemagglutinin (Anti-FHA), Anti-Pertactin (Anti-PRN)
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PT, Anti-FHA, Anti-PRN
A seropositive subject was a subject whose antibody concentration was greater than or equal to (≥) the assay cut-off of 5 ELISA units per milliliter (EL.U/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol Phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled before protocol amendment 2)
Number of Seroprotected Subjects for Anti-PRP
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: Before (PRE) booster vaccination (subjects enrolled after protocol amendment 2)
Concentrations for Anti-pneumococcal (Anti-PNE) Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Concentrations for Anti-PNE Antibodies
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Seropositive Subjects for Anti-PNE Serotypes
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: 1 month post booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens (Anti-PT, Anti-FHA and Anti-PRN)
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Measured: 1 month post booster vaccination (POST) (subjects enrolled before protocol amendment 2)
Number of Subjects With Booster Response to Anti-pertussis Antigens
Booster response defined as : - For initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL one month after booster vaccination - For initially seropositive subjects, antibody concentration at Post-booster ≥ 2 fold the pre-vaccination antibody concentration
Measured: 1 month poste booster vaccination (POST) (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited Local Symptom
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptoms
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Solicited General Symptom
Solicited local symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any Unsolicited AEs
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow up period after vaccination. (subjects enrolled after protocol amendment 2)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Measured: During the entire study period (Days 0-30). (subjects enrolled before protocol amendment 2)
Number of Subjects Reporting Any SAEs
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Measured: During the entire study period (Days 0-30). (subjects enrolled after protocol amendment 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study start14 Oct 2011
- Primary completion12 Nov 2012
- Study completion12 Nov 2012
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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 657 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
- NCT01453998
- Sponsor's protocol ID
- 114843
- Other IDs
- 2011-000876-33
- Status last verified
- Jul 2020
- First submitted
- 6 Oct 2011
- Last updated
- 17 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Vesikari T, Rivera L, Korhonen T, Ahonen A, Cheuvart B, Hezareh M, Janssens W, Mesaros N. Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa. Hum Vaccin Immunother. 2017 Jul 3;13(7):1505-1515. doi: 10.1080/21645515.2017.1294294. Epub 2017 Mar 24.
PubMed 28340322