Infections, StreptococcalPhase 3NCT01175083
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A
A Phase 3 study testing GSK1024850A (Synflorix), Tritanrix-HepB/Hib and Polio Sabin in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Burkina Faso.
Trial summary
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A. Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines. Read more about this study
- Who is it for?
- Ages 8 weeks to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Streptococcal
- What is being tested?
- GSK1024850A (Synflorix), Tritanrix-HepB/Hib and Polio Sabin
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 1 Jun 2011to 23 May 2013
- Phase
- Phase 3
- 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 8 weeks to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 visits).
- A male or female between, and including:
- 8 and 11 weeks of age at the time of the first vaccination for subjects in the <6S and <6NS groups or
- 7 and 11 months at the time of the first vaccination for subjects in the 7-11S and 7-11NS groups or
- 12 and 23 months at the time of first vaccination for subjects in the 12-23S and 12-23NS groups (Note the second dose should be administered at 23 Months of age at the latest to allow, if needed, compliance with the National Recommendations on administration of the 23-valent polysaccharide pneumococcal vaccine in children with SCD as of 24 months of age).
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
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- Additional inclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
- Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7-11S and 12-23S groups).
- Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
- Additional inclusion criteria for healthy children (<6NS, 7-11NS and 12-23NS groups):
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Children with negative diagnosis of sickle cell disease and confirmed hemoglobin status by hemoglobin chromatography and/or electrophoresis.
Who cannot join
- Child in care
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
- 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 (pharmaceutical product or device).
- Previous vaccination or planned vaccination during the study with any pneumococcal vacccine.
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- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- Major congenital malformations.
- History of any neurological disorders or seizures.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Birth weight below 1500g.
- Serious chronic illness other than SCD.
- 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°C on rectal setting. The preferred route for recording temperature in this study will be tympanic.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- Additional exclusion criteria for children with SCD (<6S, 7-11S and 12-23S groups):
- Any confirmed or suspected immunosuppressive or immunodeficient condition, (including human immunodeficiency virus (HIV) infection) other than SCD related conditions, based on medical history and physical examination (no laboratory testing required).
- Additional exclusion criteria for healthy children (<6 NS, 7-11NS and 12-23NS groups):
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
Read the detailed description
This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.
- Conditions
- Infections, Streptococcal
- Being tested
- GSK1024850A (Synflorix), Tritanrix-HepB/Hib, Polio Sabin
- Keywords
- Immunogenicity, Booster vaccination, Catch-up vaccination, Pneumococcal vaccine, Pneumococcal disease, Sickle cell disease, Safety
- Medical subject headings
- Streptococcal Infections, Pneumococcal Infections, Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK1024850A (Synflorix)Biological
2, 3 or 4 intramuscular injection
Tritanrix-HepB/HibBiological
Also called DTPw-HBV/Hib
Intramuscular injection, 4 doses
Polio SabinBiological
Also called OPV
4 oral doses
| Study group | Role | What they receive |
|---|---|---|
| Tritanrix-HepB/Hib+Polio Sabin <6S Group | Experimental | Children below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. Receives: Biological: GSK1024850A (Synflorix); Biological: Tritanrix-HepB/Hib; Biological: Polio Sabin |
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Active comparator | Healthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. Receives: Biological: GSK1024850A (Synflorix); Biological: Tritanrix-HepB/Hib; Biological: Polio Sabin |
| Synflorix 7-11S Group | Experimental | Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. Receives: Biological: GSK1024850A (Synflorix) |
| Synflorix 7-11NS Group | Active comparator | Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. Receives: Biological: GSK1024850A (Synflorix) |
| Synflorix 12-23S Group | Experimental | Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. Receives: Biological: GSK1024850A (Synflorix) |
| Synflorix 12-23NS Group | Active comparator | Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. Receives: Biological: GSK1024850A (Synflorix) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Antibodies have been assessed against the following 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 enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: One month after primary vaccination (Month 3)
Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: One month after the primary vaccination (Month 3)
Secondary outcomes (23)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Antibodies have been assessed against the following 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 enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Antibodies have been assessed against the following 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 enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Antibodies have been assessed against the following 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 enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations < 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Measured: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers < 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Measured: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.
Measured: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.
Measured: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: Within the 31-day (Days 0-30) post-primary and post-booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period from Month 0 to Month 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study start1 Jun 2011
- Primary completion17 Jan 2013
- Study completion23 May 2013
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 Infections, StreptococcalStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT01175083
- Sponsor's protocol ID
- 114056
- Other IDs
- 2012-000254-64
- Status last verified
- Feb 2019
- First submitted
- 3 Aug 2010
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Sirima SB, Tiono A, Gansane Z, Siribie M, Zongo A, Ouedraogo A, Francois N, Strezova A, Dobbelaere K, Borys D. Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study. Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518.
PubMed 28403055
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Pneumococcal Vaccine 1024850A When Administered to Children Between 8 Weeks and 2 Years of Age
- ClinicalTrials.gov ID
- NCT01175083
- Acronym / sponsor ID
- 114056
- Conditions
- Infections, Streptococcal
- Keywords
- Immunogenicity, Booster vaccination, Catch-up vaccination, Pneumococcal vaccine, Pneumococcal disease, Sickle cell disease, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2011 (actual)
- Primary completion
- 17 Jan 2013 (actual)
- Study completion
- 23 May 2013 (actual)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A.
Children that are below 6 months at the time of enrolment will also receive the DTPw-HBV/Hib and OPV vaccines.
Detailed description
This protocol posting has been updated according to Protocol Amendment 2, September 2010. The impacted sections are arms and inclusion criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tritanrix-HepB/Hib+Polio Sabin <6S Group | Experimental | Biological: GSK1024850A (Synflorix), Biological: Tritanrix-HepB/Hib, Biological: Polio SabinChildren below (<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Tritanrix-HepB/Hib+Polio Sabin <6NS Group | Active comparator | Biological: GSK1024850A (Synflorix), Biological: Tritanrix-HepB/Hib, Biological: Polio SabinHealthy children, below (<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8. |
| Synflorix 7-11S Group | Experimental | Biological: GSK1024850A (Synflorix)Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 7-11NS Group | Active comparator | Biological: GSK1024850A (Synflorix)Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3. |
| Synflorix 12-23S Group | Experimental | Biological: GSK1024850A (Synflorix)Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
| Synflorix 12-23NS Group | Active comparator | Biological: GSK1024850A (Synflorix)Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2. |
Who may qualify
- Ages
- 8 weeks to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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 visits).
- A male or female between, and including:
- Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
- Children with diagnosis of sickle cell disease [homozygous sickle cell disease (hemoglobin SS disease), double heterozygous sickle hemoglobin C disease (hemoglobin SC disease) and the sickle ß-thalassemias] and confirmed hemoglobin status by hemoglobin chromatography and electrophoresis (<6S group) or electrophoresis (7-11S and 12-23S groups).
- Free of any other known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context
Key exclusion criteria (19 listed)
- Child in care
- Use of any investigational or non-registered product (drug or vaccine) 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 (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccines and ending 30 days after. Locally recommended vaccines (recommended through the EPI program or through national immunization campaigns) for example inactivated influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the eCRF.
- 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 (pharmaceutical product or device).
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 |
|---|---|---|
| GSK1024850A (Synflorix)2, 3 or 4 intramuscular injection | Biological | Synflorix 12-23NS Group, Synflorix 12-23S Group, Synflorix 7-11NS Group, Synflorix 7-11S Group, Tritanrix-HepB/Hib+Polio Sabin <6NS Group, Tritanrix-HepB/Hib+Polio Sabin <6S Group |
| Tritanrix-HepB/HibAlso: DTPw-HBV/HibIntramuscular injection, 4 doses | Biological | Tritanrix-HepB/Hib+Polio Sabin <6NS Group, Tritanrix-HepB/Hib+Polio Sabin <6S Group |
| Polio SabinAlso: OPV4 oral doses | Biological | Tritanrix-HepB/Hib+Polio Sabin <6NS Group, Tritanrix-HepB/Hib+Polio Sabin <6S Group |
Primary outcome
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: One month after primary vaccination (Month 3)
Antibodies have been assessed against the following 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 enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: One month after the primary vaccination (Month 3)
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations < 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
23 secondary outcomes
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Time frame: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccination
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Time frame: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dose
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Time frame: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Time frame: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) post-primary and post-booster vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period from Month 0 to Month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28403055Sirima SB, Tiono A, Gansane Z, Siribie M, Zongo A, Ouedraogo A, Francois N, Strezova A, Dobbelaere K, Borys D. Immunogenicity and Safety of 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine (PHiD-CV) Administered to Children With Sickle Cell Disease Between 8 Weeks and 2 Years of Age: A Phase III, Open, Controlled Study. Pediatr Infect Dis J. 2017 May;36(5):e136-e150. doi: 10.1097/INF.0000000000001518.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GSK1024850A (Synflorix), Tritanrix-HepB/Hib and Polio Sabin in people with Infections, Streptococcal, run by GlaxoSmithKline at 1 site in Burkina Faso.
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 12 inclusion and 19 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 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines (time frame: One month after primary vaccination (Month 3)). 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 NCT01175083, 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 6 Jun 2019; AzTrials last refreshed its copy on 6 Nov 2026.