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

A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES

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.

Study Overview

• Status: Completed
• Conditions: Infections, Meningococcal
• Intervention / Treatment: Biological: Meningococcal vaccine GSK134612; Biological: Prevenar 13™

Detailed Description

The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.

• Study Type: Interventional
• Enrollment (Actual): 803
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • The Childrens Hospital at Westmead
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Women's and Children's Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3010
      • Vaccine and Immunization Research Group
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
      • The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM]
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Canadian Center for Vaccinology - IWK Health Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Dr. Allen Greenspoon Medicine Professional Corporation
    • Sudbury, Ontario, Canada, P3A 1W8
      • Medicor Research Inc.
  • Quebec
    • Quebec City, Quebec, Canada, G1E 7G9
      • CHU de Quebec-Universite Laval
• Czechia
  • Benesov, Czechia, 256 01
    • Ordinace praktického lékaře pro děti a dorost
  • Boletice nad Labem, Czechia, 40711
    • Ordinace praktického lékaře pro děti a dorost
  • Brandys nad Labem, Czechia, 250 01
    • Ordinace praktického lékaře pro děti a dorost
  • Caslav, Czechia, 286 01
    • Ordinace praktického lékaře pro děti a dorost
  • Chrastava, Czechia, 463 31
    • Ordinace praktického lékaře pro děti a dorost
  • Chrudim 2, Czechia, 537 01
    • Ordinace praktického lékaře pro děti a dorost
  • Decin, Czechia, 405 01
    • Krajska zdravotni, a.s., Nemocnice Decin
  • Domazlice, Czechia, 34401
    • Ordinace praktického lékaře pro děti a dorost
  • Holice, Czechia, 534 01
    • Ordinace praktického lékaře pro děti a dorost
  • Hradec Kralove, Czechia, 500 02
    • Ordinace praktického lékaře pro děti a dorost
  • Hradek nad Nisou, Czechia, 463 34
    • Ordinace praktického lékaře pro děti a dorost
  • Hronov, Czechia, 54931
    • Ordinace praktického lékaře pro děti a dorost
  • Jindrichuv Hradec, Czechia, 377 01
    • Ordinace praktického lékaře pro děti a dorost
  • Kladno, Czechia, 272 01
    • Ordinace praktického lékaře pro děti a dorost
  • Krupka, Czechia, 417 41
    • Ordinace praktického lékaře pro děti a dorost
  • Liberec 7, Czechia, 460 07
    • Ordinace praktického lékaře pro děti a dorost
  • Melnik, Czechia, 276 01
    • Ordinace praktického lékaře pro děti a dorost
  • Nachod, Czechia, 547 01
    • Oblastni nemocnice Nachod
  • Neveklov, Czechia, 257 56
    • Ordinace praktického lékaře pro děti a dorost
  • Novy Jicin, Czechia, 741 01
    • Ordinace praktického lékaře pro děti a dorost
  • Odolena Voda, Czechia, 250 70
    • Ordinace praktického lékaře pro děti a dorost
  • Ostrov, Czechia, 363 01
    • Ordinace praktického lékaře pro děti a dorost
  • Ostrov Nad Ohri, Czechia, 36301
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 530 03
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 530 09
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 530 12
    • Ordinace praktického lékaře pro děti a dorost
  • Pardubice, Czechia, 532 03
    • Nemocnice Pardubice
  • Praha 3, Czechia, 130 00
    • Ordinace praktického lékaře pro děti a dorost
  • Praha 5, Czechia, 15200
    • Ordinace praktického lékaře pro děti a dorost
  • Smirice, Czechia, 503 03
    • Ordinace praktického lékaře pro děti a dorost
  • Trutnov, Czechia, 541 01
    • Ordinace praktického lékaře pro děti a dorost
  • Tynec nad Sazavou, Czechia, 257 41
    • Ordinace praktického lékaře pro děti a dorost
  • Vokovice
    • Praha 6, Vokovice, Czechia, 160 00
      • Medicentrum 6 s.r.o
• Panama
  • Panama, Panama
    • Centro Pediatrico America, Consultorios America
  • Panama, Panama
    • CEVAXIN Plaza Carolina
  • Panama, Panama
    • Consultorios America Via Espana
  • Panama, Panama
    • ULAPS Guadalupe
• South Africa
  • Gauteng, South Africa, 0152
    • Setshaba Clinical Research
  • Gauteng
    • Soweto, Gauteng, South Africa, 2013
      • Chris Hani Baragwanath Academic hospital
• Turkey
  • Izmir, Turkey, 35100
    • Ege University Hospital Medical Faculty
  • Sihhiye
    • Ankara, Sihhiye, Turkey, 06100
      • Hacettepe University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACWY1d group; Subjects will receive 1 dose of the MenACWY-TT vaccine	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
Experimental: ACWY2d group; Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
Experimental: Co-ad group; Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region; Biological: Prevenar 13™; 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
Active Comparator: PCV-13 group; Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later	Biological: Meningococcal vaccine GSK134612; 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region; Biological: Prevenar 13™; 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 3
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 3
Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 5
Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 5
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	GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.	1 month after administration of Prevnar 13 (i.e. at Month 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
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	Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
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	Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
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	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
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	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1, Year 3, Year 5
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	Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1, Year 3, Year 5
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	Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1, Year 3, Year 5
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	Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.	At Year 1, Year 3, Year 5
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	Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.	1 month after administration of Prevnar 13 (i.e. at Month 1)
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	OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.	1 month after administration of Prevnar 13 (i.e. at Month 1)
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	OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.	1 month after administration of Prevnar 13 (i.e. at Month 1)
Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination	Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category.	Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])
Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination	Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively.	Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])
Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)	An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.	Within 31 days post any vaccination
Number of Participants With Serious Adverse Events From Month 0 to Month 9	An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.	Month 0 to Month 9
Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study	An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.	Baseline up to end of study (up to 5 years)
Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9	New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.	Month 0 to Month 9

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2013
• Primary Completion (Actual): December 5, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Persistence; Meningococcal vaccine; Toddlers; Prevenar 13; Co-administration; 5 years
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: MENACWY-TT-104; C0921003 (Other Identifier: Alias Study Number); 2013-001083-28 (EudraCT Number); 116892 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes