Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old

• ClinicalTrials.gov Identifier: NCT00196976
• Recruitment Status: Completed
• First Posted: September 20, 2005
• Results First Posted: March 1, 2017
• Last Update Posted: June 8, 2018
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Infections, Meningococcal	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	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 461 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Prevention
• 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
• Study Start Date: March 24, 2005
• Actual Primary Completion Date: March 1, 2006
• Actual Study Completion Date: March 3, 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: GSK134612A Form1 (T), Primary Group; 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.	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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: Mencevax™ACWY; 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)
Experimental: GSK134612A Form2 (T), Primary Group; 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.	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Experimental: GSK134612A Form3 (T), Primary Group; 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.	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Experimental: GSK134612A Form4 (T), Primary Group; 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.	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Active Comparator: Control (T), Primary Group; 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.	Biological: 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: 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: Meningitec™; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age; Biological: Mencevax™ACWY; 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)
Experimental: GSK134612A Form1 (C), Primary Group; 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).	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Experimental: GSK134612A Form2 (C), Primary Group; 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).	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Experimental: GSK134612A Form3 (C), Primary Group; 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).	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Experimental: GSK134612A Form4 (C), Primary Group; 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).	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: 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: 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
Active Comparator: Control (C), Primary Group; 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).	Biological: Mencevax™ACWY; 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)
Experimental: GSK134612A Form1 (T), Booster Group; 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).	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination; Biological: Mencevax™ACWY; 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)
Active Comparator: Control (T), Booster Group; 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).	Biological: Meningitec™; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age; Biological: Mencevax™ACWY; 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)
Experimental: GSK134612A Form1 (C), Booster Group; 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.	Biological: Conjugated meningococcal ACWY-TT (vaccine); One intramuscular dose during the primary vaccination
Active Comparator: Control (C), Booster Group; 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.	Biological: Meningitec™; One intramuscular dose during the primary vaccination study in subjects of 12-24 months of age

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Number of Seroprotected Subjects Against Different Meningococcal Serogroups [ Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose ]
   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.
2. 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 ]
   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.
3. Antibody Titers Against Different Meningococcal Serogroups [ Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose ]
   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).
4. 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 ]
   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).
5. Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides [ Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose ]
   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).
6. Antibody Concentrations Against Different Meningococcal Polysaccharides [ Time Frame: Prior to (Month 0) and one month after (Month 1) the first vaccine dose ]
   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).
7. 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 ]
   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).
8. Antibody Concentrations Against Tetanus (Anti-T) [ Time Frame: 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).
9. 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 ]
   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.
10. 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 ]
    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.
11. 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 ]
    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.
12. 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 ]
    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.
13. Number of Seroprotected Subjects Against Different Meningococcal Serogroups [ Time Frame: 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.
14. Number of Seropositive Subjects for Different Anti-meningococcal Serogroups [ Time Frame: 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.
15. Antibody Titers Against Different Meningococcal Serogroups [ Time Frame: At one month (M1) and 12 months (M12) post-primary 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).
16. Number of Seropositive Subjects for Different Anti-meningococcal Polysaccharides [ Time Frame: 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).
17. Number of Seroprotected Subjects Against Different Meningococcal Polysaccharides [ Time Frame: 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).
18. Antibody Concentrations Against Different Meningococcal Polysaccharides [ Time Frame: At one month (M1) and 12 months (M12) post-primary 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).
19. 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 ]
    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.
20. Antibody Titers Against Different Meningococcal Serogroups [ Time Frame: 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).
21. 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 ]
    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.
22. Antibody Concentrations Against Different Meningococcal Polysaccharides [ Time Frame: 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).
23. Number of Subjects With Any Solicited Local Symptoms [ Time Frame: 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.
24. Number of Subjects With Any Solicited General Symptoms [ Time Frame: 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.
25. 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 ]
    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.
26. 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 ]
    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.
27. Number of Subjects With Any Unsolicited AEs [ Time Frame: 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.
28. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: 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.
29. 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) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 12 Months to 60 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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:

  • 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.

Contacts and Locations

Locations

Austria

GSK Investigational Site

Eferding, Austria, A-4070

GSK Investigational Site

Graz, Austria, A-8036

GSK Investigational Site

Salzburg, Austria, A-5020

GSK Investigational Site

Vienna, Austria, A-1020

GSK Investigational Site

Villach, Austria, A-9500

GSK Investigational Site

Wels, Austria, A-4600

Greece

GSK Investigational Site

Athens, Greece, 11527

GSK Investigational Site

Heraklion, Crete, Greece, 71110

GSK Investigational Site

Ioannina, Greece, 452 21

GSK Investigational Site

Komotini, Greece, 69100

GSK Investigational Site

Koufalia, Greece, 571 00

GSK Investigational Site

Markopoulo, Greece, 19003

GSK Investigational Site

N. Efkarpia, Thessaloniki, Greece, 564 29

GSK Investigational Site

Nea Makri, Greece, 19005

GSK Investigational Site

Rio/Patras, Greece, 26500

GSK Investigational Site

Thessaloniki, Greece, 54636

GSK Investigational Site

Tripolis, Greece, 22100

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

Additional Information:

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. 

Study Data/Documents: Dataset Specification 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register

Informed Consent Form 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register

Statistical Analysis Plan 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register

Individual Participant Data Set 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103533 are summarised with study 103534 on the GSK Clinical Study Register.

Study Protocol 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register

Clinical Study Report 

Identifier: 103533
For additional information about this study please refer to the GSK Clinical Study Register

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00196976
• Other Study ID Numbers: 103533; 103534 ( Other Identifier: GSK )
• First Posted: September 20, 2005
• Results First Posted: March 1, 2017
• Last Update Posted: June 8, 2018
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:

Safety; Meningococcal vaccine; Dose selection; Toddlers; Immunogenicity; Conjugate vaccine; Reactogenicity; Children

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Edetic Acid; Vaccines; Pentetic Acid; Immunologic Factors; Physiological Effects of Drugs; Antidotes; Protective Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Iron Chelating Agents; Anticoagulants; Calcium Chelating Agents