AzTrials
AzTrials

Infections, StreptococcalPhase 2NCT01616459

Immunogenicity and Safety of Two Formulations of GSK Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

A Phase 2 study testing Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 42 sites in 4 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Streptococcal
What is being tested?
Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A and Synflorix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
953 participants
Where
42 sitesin 4 countries
Study dates
11 Jul 2012to 22 Jan 2014
Phase
Phase 2
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 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants.
  • Written informed consent obtained from the parents/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of at least 36 weeks.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions:
  • Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines.
  • Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines.
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  • Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age.
  • 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, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations.
  • 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 product .
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness, including Kawasaki's syndrome.
  • History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during study period.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b.
  • Previous vaccination against S. pneumoniae.
  • History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease.
  • Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.

Trial locations and contacts

42 sites in 4 countries.

42 sites in 4 countries

Germany16 sites

  • GSK Investigational Site

    Berchtesgaden, Bavaria, 83471

  • GSK Investigational Site

    Berlin, 13055

  • GSK Investigational Site

    Berlin, 14197

  • GSK Investigational Site

    Detmold, North Rhine-Westphalia, 32756

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Kirchheim, Bavaria, 85551

  • GSK Investigational Site

    Kleve-Materborn, North Rhine-Westphalia, 47533

  • GSK Investigational Site

    Löhne, North Rhine-Westphalia, 32584

  • GSK Investigational Site

    Munich, Bavaria, 81241

  • GSK Investigational Site

    Olching, Bavaria, 82140

  • GSK Investigational Site

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70469

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Wanzleben, Saxony-Anhalt, 39164

Other trials in Germany

Czechia13 sites

  • GSK Investigational Site

    Benešov, 256 01

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Domažlice, 34401

  • GSK Investigational Site

    Jindřichův Hradec, 37701

  • GSK Investigational Site

    Kladno, 272 01

  • GSK Investigational Site

    Liberec, 46015

  • GSK Investigational Site

    Lipník nad Bečvou, 75131

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Ostrava - Poruba, 70800

  • GSK Investigational Site

    Ostrov, 363 01

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 1600

Other trials in Czechia

Poland7 sites

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Oleśnica, 56-400

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Torun, 87-100

  • GSK Investigational Site

    Trzebnica, 55-100

  • GSK Investigational Site

    Warsaw, 01-809

  • GSK Investigational Site

    Wroclaw, 50345

Other trials in Poland

Spain6 sites

  • GSK Investigational Site

    Almería, 04009

  • GSK Investigational Site

    Antequera/Málaga, 29200

  • GSK Investigational Site

    Burgos, 09006

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Valencia, 46026

  • GSK Investigational Site

    Valladolid, 47012

Other trials in Spain

About this study

Official title: Immunogenicity and Safety Study of Two Formulations of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (2830929A and 2830930A) When Administered in Healthy Infants

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Read the detailed description

The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines.

Being tested
Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A, Synflorix™, Prevnar 13™, Infanrix hexa™
Keywords
Streptococcus pneumoniae, Haemophilus influenzae, Pneumococcal vaccine, Infants, Safety, Immunogenicity
Medical subject headings
Streptococcal Infections, Haemophilus Infections

What participants receive

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

  • Pneumococcal conjugate vaccine GSK2830929ABiological

    Intramuscular injection

  • Pneumococcal conjugate vaccine GSK2830930ABiological

    Intramuscular injection

  • Synflorix™Biological

    Intramuscular injection

  • Prevnar 13™Biological

    Intramuscular injection

  • Infanrix hexa™Biological

    Intramuscular injection

Study groups in NCT01616459
Study groupRoleWhat they receive
11Pn GroupExperimentalHealthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
Receives: Biological: Pneumococcal conjugate vaccine GSK2830929A; Biological: Infanrix hexa™
12Pn GroupExperimentalHealthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
Receives: Biological: Pneumococcal conjugate vaccine GSK2830930A; Biological: Infanrix hexa™
Synflorix GroupActive comparatorHealthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
Receives: Biological: Synflorix™; Biological: Infanrix hexa™
Prevnar13 GroupActive comparatorHealthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
Receives: Biological: Prevnar 13™; Biological: Infanrix hexa™

What is being measured

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

  1. Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study

    Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  2. Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes

    N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 month post-dose 3 (primary phase)

  3. Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype

    N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 month post-dose 3 (primary phase)

  4. Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes

    N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 month post-dose 3 (primary phase)

  5. Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes

    N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).

    Measured: 1 month post-dose 3 (primary phase)

Secondary outcomes (20)

  1. Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study

    Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.

    Measured: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

  2. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study

    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  3. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study

    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.

    Measured: At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine

  4. Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  5. Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study

    Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 100 EL.U/mL.

    Measured: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

  6. Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).

    Measured: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).

  7. Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study

    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).

    Measured: Within the 4-day (Days 0-3) period after booster vaccination

  8. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study

    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.

    Measured: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).

  9. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study

    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38.0 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (>) 40.0°C.

    Measured: Within the 4-day (Days 0-3) period after booster vaccination

  10. Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study

    An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

    Measured: Within the 31-day (Days 0-30) period post primary vaccination, across doses

  11. Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study

    An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

    Measured: Within the 31-day (Days 0-30) period post booster vaccination

  12. Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study

    A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

    Measured: From Month 0 to Month 3

  13. Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study

    A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.

    Measured: From Day 0 to Month 11

  14. Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study

    Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

    Measured: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

  15. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study

    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  16. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study

    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).

    Measured: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine

  17. Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.

    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  18. Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.

    No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

    Measured: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine

  19. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study

    No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

    Measured: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine

  20. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study

    No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.

    Measured: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine

Timeline

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

  1. First posted11 Jun 2012 (estimated)
  2. Study start11 Jul 2012
  3. Primary completion25 Apr 2013
  4. Study completion22 Jan 2014

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
953 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616459
Sponsor's protocol ID
116485
Other IDs
2011-005743-27
Status last verified
Jul 2019
First submitted
7 Jun 2012
Last updated
16 Jul 2019
Data monitoring committee
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site

Publications

  • Carmona Martinez A, Prymula R, Miranda Valdivieso M, Otero Reigada MDC, Merino Arribas JM, Brzostek J, Szenborn L, Ruzkova R, Horn MR, Jackowska T, Centeno-Malfaz F, Traskine M, Dobbelaere K, Borys D. Immunogenicity and safety of 11- and 12-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccines (11vPHiD-CV, 12vPHiD-CV) in infants: Results from a phase II, randomised, multicentre study. Vaccine. 2019 Jan 3;37(1):176-186. doi: 10.1016/j.vaccine.2018.07.023. Epub 2018 Jul 24.

    PubMed 30054160

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pneumococcal conjugate vaccine GSK2830929A, Pneumococcal conjugate vaccine GSK2830930A and Synflorix™ in people with Infections, Streptococcal, run by GlaxoSmithKline at 42 sites in 4 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 16 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 42 sites in Germany, Czechia, Poland, Spain. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 16 Jun 2014). 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?

Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study (time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine). 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 NCT01616459, 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 16 Jul 2019.

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