Infections, MeningococcalPhase 2NCT00196976
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
A Phase 2 study testing Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in people with Infections, Meningococcal, run by GlaxoSmithKline at 17 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. Read more about this study
- Who is it for?
- Ages 12 to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 461 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 24 Mar 2005to 3 Mar 2006
- 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 12 to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Who cannot join
- 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
- Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
- For subjects aged 12-14 months at enrolment:
Show all 17Show fewer
- For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
- History of meningococcal serogroup A, C, W-135 or Y disease.
- Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Greece11 sites
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Heraklion, Crete, 71110
GSK Investigational Site
Ioannina, 452 21
GSK Investigational Site
Komotini, 69100
GSK Investigational Site
Koufalia, 571 00
GSK Investigational Site
Markopoulo Mesogaias, 19003
GSK Investigational Site
N. Efkarpia, Thessaloniki, 564 29
GSK Investigational Site
Nea Makri, 19005
GSK Investigational Site
Rio/Patras, 26500
GSK Investigational Site
Thessaloniki, 54636
GSK Investigational Site
Tripoli, 22100
Austria6 sites
GSK Investigational Site
Eferding, A-4070
GSK Investigational Site
Graz, A-8036
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Vienna, A-1020
GSK Investigational Site
Villach, A-9500
GSK Investigational Site
Wels, A-4600
About this study
Official title: Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
- Conditions
- Infections, Meningococcal
- Being tested
- Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™), Meningitec™, Mencevax™ACWY
- Keywords
- Safety, Meningococcal vaccine, Dose selection, Toddlers, Immunogenicity, Conjugate vaccine, Reactogenicity, Children
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conjugated meningococcal ACWY-TT (vaccine)Biological
One intramuscular dose during the primary vaccination
DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)Biological
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only
DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Biological
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only
Meningitec™Biological
One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age
Mencevax™ACWYBiological
One subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E)
| Study group | Role | What they receive |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Experimental | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™); Biological: Mencevax™ACWY |
| GSK134612A Form2 (T), Primary Group | Experimental | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| GSK134612A Form3 (T), Primary Group | Experimental | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| GSK134612A Form4 (T), Primary Group | Experimental | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| Control (T), Primary Group | Active comparator | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. Receives: Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™); Biological: Meningitec™; Biological: Mencevax™ACWY |
| GSK134612A Form1 (C), Primary Group | Experimental | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| GSK134612A Form2 (C), Primary Group | Experimental | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| GSK134612A Form3 (C), Primary Group | Experimental | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| GSK134612A Form4 (C), Primary Group | Experimental | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib); Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) |
| Control (C), Primary Group | Active comparator | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533). Receives: Biological: Mencevax™ACWY |
| GSK134612A Form1 (T), Booster Group | Experimental | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine); Biological: Mencevax™ACWY |
| Control (T), Booster Group | Active comparator | Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). Receives: Biological: Meningitec™; Biological: Mencevax™ACWY |
| GSK134612A Form1 (C), Booster Group | Experimental | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination. Receives: Biological: Conjugated meningococcal ACWY-TT (vaccine) |
| Control (C), Booster Group | Active comparator | Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination. Receives: Biological: Meningitec™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
Measured: One month after the first vaccine dose (Month 1)
Secondary outcomes (29)
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Measured: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
A seropositive subject for anti-tetanus was defined as having antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units per milliliter (IU/mL). Antibody titers were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Tetanus (Anti-T)
Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) method, presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Toddlers With Any Solicited Local Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited Local Symptoms
The children subgroup received one dose of the meningococcal vaccine. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Toddlers With Any Solicited General Symptoms
The toddlers subgroup received 2 primary vaccine doses, as follows: first dose of a meningococcal vaccine and second dose of a diphtheria, tetanus and acellular pertusis-containing vaccine. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Measured: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited General Symptoms
The children subgroup received one primary meningococcal vaccine dose. Assessed solicited general symptoms included drowsiness, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Measured: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
A seroprotected subject against meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY assessed, was defined as having antibody titers greater than or equal to (≥) 1:8.
Measured: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
A seropositive subject for meningococcal serogroups rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Y assessed, was defined as having antibody titers greater than or equal to (≥) 1:128.
Measured: At one month (M1) and 12 months (M12) post-primary vaccination
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Measured: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
A seropositive subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the cut-off value of 0.3 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seroprotected subject for meningococcal polysaccharide A (PSA), C (PSC), W-135 (PSW-135) and Y (PSY) assessed, was defined as having antibody (anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY) concentrations greater than or equal to (≥) the value of 2.0 micrograms per milliliter (μg/mL). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: At one month (M1) and 12 months (M12) post primary vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
A seropositive subject for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY was defined as a vaccinated subject with antibody titers greater than or equal to (≥) 1:128, while for a seroprotected subject, titers were ≥1:8.
Measured: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Titers Against Different Meningococcal Serogroups
Antibody titers against meningococcal serogroups A, C, W-135 and Y (MenA, MenC, MenW-135 and MenY) have been assessed, using rabbit complement and expressed as geometric mean titers (GMTs).
Measured: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
A seropositive subject for anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY was defined as a vaccinated subject with antibody concentrations greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL), while for a seroprotected subject, antibody concentrations were ≥ 2.0 μg/mL.
Measured: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
The meningococcal polysaccharides assessed included polysaccharide A (anti-PSA), polysaccharide B (anti-PSB), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY). Antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL).
Measured: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = incidence of a particular symptom regardless of intensity or relationship to vaccination.
Measured: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
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 31 days (Days 0-30) after the primary meningococcal vaccination
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
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 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Number of Subjects With Any Unsolicited 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 31 days (Days 0-30) after the booster vaccination
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 primary vaccination study (from Month 0 up to Month 2)
Number of Subjects With 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: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study start24 Mar 2005
- Primary completion1 Mar 2006
- Study completion3 Mar 2006
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.
- Other trials for Infections, MeningococcalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 461 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
- NCT00196976
- Sponsor's protocol ID
- 103533
- Other IDs
- 103534
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jun 2018
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Immunogenicity, Reactogenicity, Safety of 4 Different Formulations of GSK Biologicals' Conjugate Vaccine (MenACWY) vs 1 Dose of MenC-CRM197 or Mencevax™ ACWY in Children Aged 12-14 Months & 3-5 Years
- ClinicalTrials.gov ID
- NCT00196976
- Acronym / sponsor ID
- 103533
- Conditions
- Infections, Meningococcal
- Keywords
- Safety, Meningococcal vaccine, Dose selection, Toddlers, Immunogenicity, Conjugate vaccine, Reactogenicity, Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 461 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2005
- Primary completion
- 1 Mar 2006 (actual)
- Study completion
- 3 Mar 2006 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 1 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years. The selection of the best formulation will be based on data obtained up to one month after the vaccine dose.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age. 3 formulations of GSK's MenACWY conjugate vaccine will be administered in a double-blind manner, while the 4th one will be single-blinded. Administration of the candidate vaccine or the active controls (MenC-CRM197 or Mencevax™ ACWY) will be done in an open manner. The study will be conducted in two stages: The primary vaccination phase (Study Stage 1) of the study will include all subjects; the second (booster/persistence) phase of the study (Study Stage 2) will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation.
The study will be conducted in a double-blind manner for groups receiving formulations A, B, C and in single blind manner with respect to the group receiving formulation D. The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens.
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| GSK134612A Form1 (T), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™), Biological: Mencevax™ACWYHealthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form2 (T), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form3 (T), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form4 (T), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| Control (T), Primary Group | Active comparator | Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™), Biological: Meningitec™, Biological: Mencevax™ACWYHealthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, were administered one dose of Pfizer's Meningitec™ conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). In accordance with local immunization policy, one dose of a diphtheria, tetanus and acellular pertusis (Infanrix™ or Infanrix™ Hexa) vaccine was also administered intramuscularly into the left thigh, one month after meningococcal vaccination. |
| GSK134612A Form1 (C), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 1 (Form1) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form2 (C), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 2 (Form2) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form3 (C), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 3 (Form3) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| GSK134612A Form4 (C), Primary Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of formulation 4 (Form4) of the GSK134612A conjugate vaccine, intramuscularly into the left arm's deltoid region, during this primary vaccination study (103533). |
| Control (C), Primary Group | Active comparator | Biological: Mencevax™ACWYHealthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, were administered one dose of Mencevax™ ACWY vaccine, subcutaneously into the left upper arm, during this primary vaccination study (103533). |
| GSK134612A Form1 (T), Booster Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine), Biological: Mencevax™ACWYHealthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). |
| Control (T), Booster Group | Active comparator | Biological: Meningitec™, Biological: Mencevax™ACWYHealthy male and female toddlers (T) between, and including, 12 to 14 months of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, additionally received 1/5 dose of Mencevax™ ACWY vaccine subcutaneously into the left upper arm, during the booster study (103534). |
| GSK134612A Form1 (C), Booster Group | Experimental | Biological: Conjugated meningococcal ACWY-TT (vaccine)Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with formulation 1 (Form1) of the GSK134612A conjugate vaccine, did not receive any booster vaccination. |
| Control (C), Booster Group | Active comparator | Biological: Meningitec™Healthy male and female children (C) between, and including, 3 to 5 years of age at the time of the first vaccination, who 12 months after being primed with Pfizer's Meningitec™ conjugate vaccine, did not receive any booster vaccination. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including 12 and 14 months or 3 and 5 years of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Previously completed routine childhood vaccinations to the best of his/her parents'/guardians' knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Key exclusion criteria (17 listed)
- 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) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV).
- Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
- Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
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 |
|---|---|---|
| Conjugated meningococcal ACWY-TT (vaccine)One intramuscular dose during the primary vaccination | Biological | GSK134612A Form1 (C), Booster Group, GSK134612A Form1 (C), Primary Group, GSK134612A Form1 (T), Booster Group, GSK134612A Form1 (T), Primary Group, GSK134612A Form2 (C), Primary Group, GSK134612A Form2 (T), Primary Group, GSK134612A Form3 (C), Primary Group, GSK134612A Form3 (T), Primary Group, GSK134612A Form4 (C), Primary Group, GSK134612A Form4 (T), Primary Group |
| DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Greece only | Biological | Control (T), Primary Group, GSK134612A Form1 (C), Primary Group, GSK134612A Form1 (T), Primary Group, GSK134612A Form2 (C), Primary Group, GSK134612A Form2 (T), Primary Group, GSK134612A Form3 (C), Primary Group, GSK134612A Form3 (T), Primary Group, GSK134612A Form4 (C), Primary Group, GSK134612A Form4 (T), Primary Group |
| DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age, in Austria only | Biological | Control (T), Primary Group, GSK134612A Form1 (C), Primary Group, GSK134612A Form1 (T), Primary Group, GSK134612A Form2 (C), Primary Group, GSK134612A Form2 (T), Primary Group, GSK134612A Form3 (C), Primary Group, GSK134612A Form3 (T), Primary Group, GSK134612A Form4 (C), Primary Group, GSK134612A Form4 (T), Primary Group |
| Meningitec™One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age | Biological | Control (C), Booster Group, Control (T), Booster Group, Control (T), Primary Group |
| Mencevax™ACWYOne subcutaneous dose during the primary vaccination study in subjects of 3-5 years of age (Group E) and intramuscular administration of 1/5 dose during the booster vaccination study in subjects of 12-14 months of age (Groups A and E) | Biological | Control (C), Primary Group, Control (T), Booster Group, Control (T), Primary Group, GSK134612A Form1 (T), Booster Group, GSK134612A Form1 (T), Primary Group |
Primary outcome
Number of Subjects With an Immune Response to Different Meningococcal Serogroups
Time frame: One month after the first vaccine dose (Month 1)
A responder to serum bactericidal assay meningococcal serogroups A, C, W and Y, using rabbit complement (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) was defined as follows: -for initially seronegative subjects (antibody titers < 1:8 for rSBA-Men), a subject achieving a post-vaccination rSBA-Men antibody titer of ≥ 1:32; - for initially seropositive subjects (antibody titers ≥ 1:8 for rSBA-Men), a subject having a ≥ 4-fold increase in rSBA-Men antibody titer from pre to post vaccination.
29 secondary outcomes
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Time frame: Prior to (Month 0) and one month after (Month 1) after the first vaccine dose
Antibody Titers Against Different Meningococcal Serogroups
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Different Meningococcal Polysaccharides
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Seropositive Subjects for Anti-tetanus (Anti-T)
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Antibody Concentrations Against Tetanus (Anti-T)
Time frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose
Number of Toddlers With Any Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Toddlers With Any Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Children With Any Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose
Number of Seroprotected Subjects Against Different Meningococcal Serogroups
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Antibody Titers Against Different Meningococcal Serogroups
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time frame: At one month (M1) and 12 months (M12) post primary vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
Time frame: At one month (M1) and 12 months (M12) post-primary vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Titers Against Different Meningococcal Serogroups
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Antibody Concentrations Against Different Meningococcal Polysaccharides
Time frame: Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period following booster dose
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination
Time frame: Within 31 days (Days 0-30) after the primary meningococcal vaccination
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination
Time frame: Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, during the primary vaccination
Number of Subjects With Any Unsolicited AEs
Time frame: Within 31 days (Days 0-30) after the booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the primary vaccination study (from Month 0 up to Month 2)
Number of Subjects With SAEs
Time frame: Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) in people with Infections, Meningococcal, run by GlaxoSmithKline at 17 sites in 2 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 17 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Greece, Austria. 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 1 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With an Immune Response to Different Meningococcal Serogroups (time frame: One month after the first vaccine dose (Month 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2018.