Skip to content
DataLookout
Start free
Menu

NCT03621670

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

StatusCompleted
PhasePhase 3
Primary completion
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 40 versions: 39 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Results first posted: Feb 10, 2026v39
  2. Primary endpoints: 15 to 19
    • Study sites: 59 to 57
    • Secondary endpoints revised (23)
    • Study description expanded, about 63 words
    v38
  3. Trial status: Active, Not Recruiting to Completedv37 Show 4 more changesShow less
    • Enrollment target: estimated 1200 to confirmed 1196
    • Study sites: 58 to 59
    • Primary completion date changed from estimate of Dec 31, 2024 to Dec 27, 2024
    • Study completion date changed from estimate of May 23, 2025 to Dec 27, 2024
  4. Study sites: 57 to 58
    • Primary completion date: Oct 8, 2024 to Dec 31, 2024
    • Study completion date: Oct 8, 2024 to May 23, 2025
    v36
  5. Primary endpoints revised (15)
    • Study sites: 59 to 57
    • Primary and study completion dates: Aug 20, 2024 to Oct 8, 2024
    • Interventions: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) (Biological), Hiberix (Biological), M-M-R II (Biological), Pediarix… to Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) (Biological), Hiberix (Biological), M-M-R II (Biological), Pediarix…
    v35
Show 33 earlier versionsHide 33 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 61 to 59
    v34
  2. Study sites: 60 to 61
    • Primary and study completion dates: May 27, 2024 to Aug 20, 2024
    • Study description expanded, about 34 words
    v33
  3. Site details revised at 1 of 60 sitesv32
  4. Study sites: 59 to 60
    • Primary and study completion dates: Jul 22, 2024 to May 27, 2024
    v31
  5. Study sites: 58 to 59v30
  6. Site details revised at 3 of 58 sitesv29
  7. Study sites: 55 to 58v28
  8. Study sites: 51 to 55v27
  9. Primary endpoints revised (15)
    • Study sites: 50 to 51
    • Secondary endpoints: 17 to 23
    • Study title shortened, about 2 words
    v26
  10. Site details revised at 4 of 50 sitesv25
  11. Site details revised at 3 of 50 sitesv24
  12. Site details revised at 1 of 50 sitesv23
  13. Site details revised at 3 of 50 sitesv22
  14. Site details revised at 1 of 50 sitesv21
  15. Primary and study completion dates: Oct 9, 2023 to Jul 22, 2024v20
  16. Enrollment target: 1800 to 1200
    • Primary and study completion dates: Jun 10, 2024 to Oct 9, 2023
    v19
  17. Trial status: Suspended to Recruiting
    • Study sites: 48 to 50
    v18
  18. Trial status: Recruiting to Suspended Sponsor's reason: Due to the COVID-19 pandemic, this study has temporarily suspended recruitment activities. Other elements of the study are ongoing.
    • Study sites: 50 to 48
    v17
  19. Enrollment target: 2700 to 1800
    • Primary and study completion dates: May 29, 2023 to Jun 10, 2024
    • Study sites: 75 to 50
    v16
  20. Primary endpoints revised (15)
    • Study sites: 32 to 75
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (17)
    v15
  21. Site details revised at 1 of 32 sitesv14
  22. Site details revised at 1 of 32 sitesv13
  23. Site details revised at 1 of 32 sitesv12
  24. Study sites: 31 to 32v11
  25. Site details revised at 1 of 31 sitesv10
  26. Site details revised at 1 of 31 sitesv9
  27. Site details revised at 5 of 31 sitesv8
  28. Site details revised at 1 of 31 sitesv7
  29. Study sites: 30 to 31v6
  30. Site details revised at 1 of 30 sitesv5
  31. Study sites: 26 to 30v4
  32. Study sites: 24 to 26v3
  33. Study sites: 15 to 24v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1
Timeframe: Day 1 to Day 7
Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1
Timeframe: Day 1 to Day 7
Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61
Timeframe: Day 61 to Day 67
Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61
Timeframe: Day 61 to Day 67
Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121
Timeframe: Day 121 to Day 127
Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121
Timeframe: Day 121 to Day 127
Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301
Timeframe: Day 301 to Day 307
Number of Participants Reporting Any Solicited Systemic Events After the Fourth Vaccination Administered at Day 301
Timeframe: Day 301 to Day 307
Number of Participants With Any Solicited Systemic AEs During the 30 Days After the Fourth Vaccination at Day 301
Timeframe: Day 301 to Day 330
Number of Participants Reporting Any Unsolicited Adverse Events (AEs) After the First Vaccination Administered at Day 1
Timeframe: Day 1 to Day 30
Number of Participants Reporting Any Unsolicited AEs After the Second Vaccination Administered at Day 61
Timeframe: Day 61 to Day 90
Number of Participants Reporting Any Unsolicted AEs After the Third Vaccination Administered at Day 121
Timeframe: Day 121 to Day 150
Number of Participants Reporting Any Unsolicited AEs After the Fourth Vaccination Administered at Day 301
Timeframe: Day 301 to Day 330
Number of Participants Reporting Any SAEs, AEs Leading to Withdrawal, AESIs and MAAEs
Timeframe: Day 1 up to study end (Day 481 for participants who have not reached 6-month follow-up at the time of Protocol Amendment 7; Day 661 for all others)
Percentage of Participants With Human Serum Bactericidal Assay (hSBA) Antibody Titers >= Lower Limit of Quantitation (LLOQ) for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4) and M13520 (NHBA)
Timeframe: At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Titers >= LLOQ Against All Serogroup B Test Strains Combined (Composite Response)
Timeframe: At Day 151 (1 month after the third vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA) and >= 16 for Strain 96217
Timeframe: At Day 331 (1 month after the fourth vaccination)
Percentage of Participants With hSBA Antibody Titers >= 8 for Strains M14459 (fHbp), NZ98/254 (PorA P1.4), and M13520 (NHBA) and >= 16 for Strain 96217 (NadA) (Composite Response Across All Strains)
Timeframe: At Day 331 (1 month after the fourth vaccination)
Adjusted Geometric Mean Concentrations (GMCs) of Immunoglobubin (IgG) Antibodies Against 13 PCV13 Antigens at 1 Month After Third Vaccination
Timeframe: At Day 151 (1 month after the third vaccination)

Secondary (23)

Adjusted GMCs of IgG Antibodies Against 13 PCV13 Antigens at 1 Month After the Fourth Vaccination Administered at Day 301
Percentage of Participants With Serum Pneumococcal Anti-capsular Polysaccharide IgG >= 0.35 μg/mL
Adjusted GMCs Against 3 Pertussis Antigens (Pertussis Toxin [PT], Pertactin [PRN], Filamentous Hemagglutinin [FHA])
Percentage of Participants With Antibodies Concentrations Against Hepatitis B Surface Antigen (AntiHBsAg) >= 10 mIU/mL
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 0.1 IU/mL
Show 18 moreShow less
Percentage of Participants With Anti-polyribosyl-ribitol Phosphate (PRP) Concentration >= 0.15 µg/mL and >= 1 µg/mL
Adjusted GMCs for Anti-measles Antibodies
Adjusted GMCs for Anti-mumps Antibodies
Adjusted GMCs for Anti-rubella Antibodies
Adjusted GMCs for Anti-Varicella (VV) Antibodies
Percentage of Participants With hSBA Antibody Titers >= 5, >= 8 and >=16 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
Percentage of Participants With hSBA Antibody Titers >= 5 and >= 8 for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
Percentage of Participants With hSBA Antibody Titers >= 5 for Each of the Serogroup B Test Strain M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
hSBA Geometric Mean Titers (GMTs) Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
hSBA Geometric Mean Ratios (GMRs) Over Pre Fourth Vaccination Against Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
Percentage of Participants With hSBA Antibody Titers >= LLOQ for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Test Strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA)
Percentage of Participants With Anti-HBs Antibody Concentrations >= 100 mIU/mL
GMCs for Anti-HBsAg Antibodies
Percentage of Participants With Anti-diphtheria and Anti-tetanus Antibody Concentrations >= 1 IU/mL
GMCs for Anti-diphtheria and Anti-tetanus Antibodies
Percentage of Participants With Anti-polio Type 1, 2 and 3 Neutralization Antibody Titers >= 8
Percentage of Participants With Seroresponse for Anti-Varicella (VV), Anti-measles Virus, Anti-mumps Virus and Anti-rubella Virus Antibodies

Arms and interventions

MenB+PCV GroupExperimental

Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301.

Placebo+PCV GroupPlacebo comparator

Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301.

Biologicals: Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ), Prevnar13, Pediarix, Hiberix, Rotarix, M-M-R II, Varivax, Placebo (saline water), Prevnar 20

Sites

57 sites in 2 countries

United States 56, Puerto Rico 1