Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
- Conditions
- Infections, Meningococcal
- Interventions
- Biological: Conjugated meningococcal ACWY-TT (vaccine)Biological: DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib)Biological: DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)Biological: Meningitec™Biological: Mencevax™ACWY
- Registration Number
- NCT00196976
- Lead Sponsor
- GlaxoSmithKline
- Brief 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. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 461
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GSK134612A Form1 (T), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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. GSK134612A Form1 (T), Primary Group 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 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 Form1 (T), Primary Group Mencevax™ACWY 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. GSK134612A Form3 (T), Primary Group Conjugated meningococcal ACWY-TT (vaccine) 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. Control (T), Primary Group 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 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. Control (T), Primary Group Mencevax™ACWY 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. GSK134612A Form2 (T), Primary Group Conjugated meningococcal ACWY-TT (vaccine) 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 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 DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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. GSK134612A Form1 (C), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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 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 Form4 (C), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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). GSK134612A Form1 (T), Primary Group Conjugated meningococcal ACWY-TT (vaccine) 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. GSK134612A Form3 (T), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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 Conjugated meningococcal ACWY-TT (vaccine) 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. GSK134612A Form4 (T), Primary Group 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. GSK134612A Form2 (T), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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 Form2 (T), Primary Group 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. Control (T), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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. GSK134612A Form1 (C), Primary Group 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 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, 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 Form2 (C), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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 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). Control (T), Primary Group Meningitec™ 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. Control (C), Primary Group Mencevax™ACWY 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). GSK134612A Form1 (T), Booster Group Mencevax™ACWY 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). Control (T), Booster Group Meningitec™ 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). Control (C), Booster Group 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. GSK134612A Form1 (C), Primary Group 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, 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 Form4 (C), Primary Group 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). GSK134612A Form1 (T), Booster Group Conjugated meningococcal ACWY-TT (vaccine) 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). GSK134612A Form3 (C), Primary Group 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, 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 Form3 (C), Primary Group DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib) 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 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, 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 (T), Booster Group Mencevax™ACWY 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). GSK134612A Form1 (C), Booster Group 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.
- Primary Outcome Measures
Name Time Method Number of Subjects With an Immune Response to Different Meningococcal Serogroups 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.
- Secondary Outcome Measures
Name Time Method Antibody Titers Against Different Meningococcal Serogroups Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination 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).
Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides At one month (M1) and 12 months (M12) post-primary vaccination 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).
Number of Seropositive Subjects for Anti-tetanus (Anti-T) Prior to (Month 0) and one month after (Month 1) the first vaccine dose 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).
Antibody Concentrations Against Tetanus (Anti-T) Prior to (Month 0) and one month after (Month 1) the first vaccine dose 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).
Number of Children With Any Solicited Local Symptoms During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose 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.
Number of Toddlers With Any Solicited Local Symptoms During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose 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.
Number of Toddlers With Any Solicited General Symptoms During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose 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.
Number of Seroprotected Subjects Against Different Meningococcal Serogroups At one month (M1) and 12 months (M12) post-primary vaccination 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.
Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides At one month (M1) and 12 months (M12) post primary vaccination 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).
Number of Seropositive Subjects for Different Anti-meningococcal Serogroups At one month (M1) and 12 months (M12) post-primary vaccination 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.
Number of Children With Any Solicited General Symptoms During the 8-day (Days 0-7) post-vaccination period after each primary vaccine dose 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.
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Serogroups Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination 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.
Antibody Concentrations Against Different Meningococcal Polysaccharides Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination 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).
Number of Seropositive and Seroprotected Subjects Against Different Meningococcal Polysaccharides Before (PRE= at Month 12) and one month after (at Month 13) booster vaccination 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.
Number of Subjects With Any Solicited General Symptoms During the 8-day (Days 0-7) post-vaccination period following booster dose 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.
Number of Subjects With Any Solicited Local Symptoms During the 8-day (Days 0-7) post-vaccination period following booster dose Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Number of Subjects With Any Unsolicited Adverse Events (AEs) After the Primary Vaccination Within 31 days (Days 0-30) after the primary meningococcal 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.
Number of Subjects With SAEs Since the last study contact in the primary study up to the end of the booster study (from Month 2 up to Month 13) 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.
Number of Subjects With Any Unsolicited AEs During the Primary Vaccination Within 31 days (Days 0-30) post-vaccination with diphteria, tetanus and acellular pertusis-containing vaccine, 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.
Number of Subjects With Any Unsolicited AEs Within 31 days (Days 0-30) after the booster 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.
Number of Subjects With Serious Adverse Events (SAEs) During the primary vaccination study (from Month 0 up to Month 2) 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.
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇷Tripolis, Greece