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Phase 3 Completed N=803 Randomized Prevention

Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

Infections, Meningococcal
Source: ClinicalTrials.gov NCT01939158 ↗
Enrolled (actual)
803
Serious AEs
6.5%
Results posted
Oct 2021
Primary outcomePrimary: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups — 97.8; 96.8; 94.9; 95.0 percentage of participants
◆ Published Evidence
Emerging
5citations · ~2 / year
A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children.
Vaccine · 2023 · Likely link

Summary

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

Linked Publications

  • A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children.
    Vaccine · 2023 · 5 citations · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
97.8; 96.8; 94.9; 95.0; 95.5; 96.0
PRIMARY
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
98.0; 98.7; 100.0; 99.3
PRIMARY
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
63.5; 70.6; 49.1; 55.2; 65.3; 77.6
PRIMARY
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
62.7; 76.6; 16.2; 21.2; 57.2; 123.1
PRIMARY
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
46.9; 54.5; 35.4; 33.9; 59.2; 72.7
PRIMARY
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
29.7; 28.5; 9.8; 11.5; 42.5; 92.9
PRIMARY
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
58.6; 65.8; 20.5; 28.4; 44.4; 50.4
PRIMARY
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
46.8; 69.9; 6.6; 8.5; 25.0; 37.1
PRIMARY
Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
2.94; 2.62; 0.80; 0.71; 2.46; 1.96
SECONDARY
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
95.9; 97.0; 98.7; 97.1; 62.5; 68.9
SECONDARY
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
97.0; 100.0; 97.1; 95.3; 97.0; 100.0
SECONDARY
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups
118.0; 132.9; 151.9; 160.8; 27.5; 26.2
SECONDARY
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
170.5; 1753.3; 756.8; 513.0
SECONDARY
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
96.4; 95.3; 96.4; 97.0; 95.9; 85.8
SECONDARY
Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group
1957.7; 376.4; 3490.5; 1481.2
SECONDARY
Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups
94.4; 95.6; 93.8; 85.5; 85.4; 88.1
SECONDARY
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups
1437.0; 1275.2; 1146.4; 452.3; 369.3; 337.3
SECONDARY
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
37.1; 35.5; 81.7; 93.7; 95.8; 98.5
SECONDARY
Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
6.1; 6.4; 35.2; 73.4; 209.0; 232.6
SECONDARY
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
66.5; 70.4; 42.7; 50.3; 60.2; 72.8
SECONDARY
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups
59.5; 119.4; 12.6; 16.0; 52.0; 109.5
SECONDARY
Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
100; 100; 99.3; 97.5; 100; 99.4
SECONDARY
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
93.8; 90.7; 98.7; 100; 100; 100
SECONDARY
Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups
116.1; 106.1; 137.6; 122.0; 2194.8; 2210.1
SECONDARY
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
52; 64; 72; 85; 72; 58
SECONDARY
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
62; 73; 85; 72; 60; 50
SECONDARY
Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)
11; 15; 11; 11
SECONDARY
Number of Participants With Serious Adverse Events From Month 0 to Month 9
8; 6; 10; 5
SECONDARY
Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study
0; 2; 1; 0
SECONDARY
Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9
2; 3; 1; 5

Eligibility Criteria

Inclusion Criteria

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.

Exclusion Criteria

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Previous vaccination against Neisseria meningitidis.
  • Previous booster vaccination against Streptococcus pneumoniae.
  • Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*
  • Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01939158) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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