AzTrials
AzTrials

Infections, MeningococcalPhase 3NCT01939158

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 3 study testing Meningococcal vaccine GSK134612 and Prevenar 13™ in people with Infections, Meningococcal, run by Pfizer at 51 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 14 monthsHealthy volunteers can take part
Conditions the study is for
Infections, Meningococcal
What is being tested?
Meningococcal vaccine GSK134612 and Prevenar 13™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
803 participants
Where
51 sitesin 6 countries
Study dates
2 Oct 2013to 5 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 14 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

51 sites in 6 countries.

51 sites in 6 countries

Czechia33 sites

  • Ordinace praktickeho lekare pro deti a dorost

    Benešov, 256 01

  • Ordinace praktickeho lekare pro deti a dorost

    Boletice nad Labem, 40711

  • Ordinace praktickeho lekare pro deti a dorost

    Brandýs nad Labem, 250 01

  • Ordinace praktickeho lekare pro deti a dorost

    Čáslav, 286 01

  • Ordinace praktickeho lekare pro deti a dorost

    Chrastava, 463 31

  • Ordinace praktickeho lekare pro deti a dorost

    Chrudim, 537 01

  • Krajska zdravotni, a.s., Nemocnice Decin

    Děčín, 405 01

  • Ordinace praktickeho lekare pro deti a dorost

    Domažlice, 34401

  • Ordinace praktickeho lekare pro deti a dorost

    Holice, 534 01

  • Ordinace praktickeho lekare pro deti a dorost

    Hradec Králové, 500 02

  • Ordinace praktickeho lekare pro deti a dorost

    Hrádek nad Nisou, 463 34

  • Ordinace praktickeho lekare pro deti a dorost

    Hronov, 54931

  • Ordinace praktickeho lekare pro deti a dorost

    Jindřichův Hradec, 377 01

  • Ordinace Praktickeho Lekare Pro Deti A Dorost

    Kladno, 272 01

  • Ordinace praktickeho lekare pro deti a dorost

    Krupka, 417 41

  • Ordinace praktickeho lekare pro deti a dorost

    Liberec, 460 07

  • Ordinace praktickeho lekare pro deti a dorost

    Mělník, 276 01

  • Oblastni nemocnice Nachod

    Náchod, 547 01

  • Ordinace praktickeho lekare pro deti a dorost

    Neveklov, 257 56

  • Ordinace praktickeho lekare pro deti a dorost

    Nový Jičín, 741 01

  • Ordinace Praktickeho Lekare pro deti a dorost

    Odolena Voda, 250 70

  • Ordinace praktickeho lekare pro deti a dorost

    Ostrov, 363 01

  • Ordinace praktickeho lekare pro deti a dorost

    Ostrov, 36301

  • Ordinace praktickeho lekare pro deti a dorost

    Pardubice, 530 03

  • Ordinace praktickeho lekare pro deti a dorost

    Pardubice, 530 09

  • Ordinace praktickeho lekare pro deti a dorost

    Pardubice, 530 12

  • Nemocnice Pardubice

    Pardubice, 532 03

  • Medicentrum 6 s.r.o

    Prague, Vokovice, 160 00

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 130 00

  • Ordinace praktickeho lekare pro deti a dorost

    Prague, 15200

  • Ordinace praktickeho lekare pro deti a dorost

    Smiřice, 503 03

  • Ordinace Praktickeho Lekare pro deti a dorost

    Trutnov, 541 01

  • Ordinace praktickeho lekare pro deti a dorost

    Týnec nad Sázavou, 257 41

Other trials in Czechia

Australia5 sites

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Vaccine and Immunization Research Group

    Melbourne, Victoria, 3010

  • Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital

    Nedlands, Western Australia, 6009

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • The Childrens Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Canada5 sites

  • Medicor Research Inc.

    Greater Sudbury, Ontario, P3A 1W8

  • Canadian Center for Vaccinology - IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • Dr. Allen Greenspoon Medicine Professional Corporation

    Hamilton, Ontario, L8L 5G8

  • CHU de Quebec-Universite Laval

    Québec, Quebec, G1E 7G9

  • The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM]

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Panama4 sites

  • Centro Pediatrico America, Consultorios America

    Panama City

  • CEVAXIN Plaza Carolina

    Panama City

  • Consultorios America Via Espana

    Panama City

  • ULAPS Guadalupe

    Panama City

Other trials in Panama

South Africa2 sites

  • Setshaba Clinical Research

    Gauteng, 0152

  • Chris Hani Baragwanath Academic Hospital

    Soweto, Gauteng, 2013

Other trials in South Africa

Turkey (Türkiye)2 sites

  • Hacettepe University Faculty of Medicine

    Ankara, Sihhiye, 06100

  • Ege University Hospital Medical Faculty

    Izmir, 35100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Meningococcal vaccine GSK134612, Prevenar 13™
Keywords
Co-administration, Safety, Persistence, Immunogenicity, Prevenar 13, Meningococcal vaccine, Toddlers, 5 years
Medical subject headings
Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meningococcal vaccine GSK134612Biological

    1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

  • Prevenar 13™Biological

    1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

Study groups in NCT01939158
Study groupRoleWhat they receive
ACWY1d groupExperimentalSubjects will receive 1 dose of the MenACWY-TT vaccine
Receives: Biological: Meningococcal vaccine GSK134612
ACWY2d groupExperimentalSubjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart
Receives: Biological: Meningococcal vaccine GSK134612
Co-ad groupExperimentalSubjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™
Receives: Biological: Meningococcal vaccine GSK134612; Biological: Prevenar 13™
PCV-13 groupActive comparatorSubjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later
Receives: Biological: Meningococcal vaccine GSK134612; Biological: Prevenar 13™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

  2. 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.

    Measured: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

  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.

    Measured: At Year 1

  4. 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.

    Measured: At Year 1

  5. 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.

    Measured: At Year 3

  6. 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.

    Measured: At Year 3

  7. 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.

    Measured: At Year 5

  8. 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.

    Measured: At Year 5

  9. 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.

    Measured: 1 month after administration of Prevnar 13 (i.e. at Month 1)

Secondary outcomes (21)

  1. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

  2. 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.

    Measured: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

  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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

  4. 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.

    Measured: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)

  5. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

  6. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)

  7. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

  8. 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.

    Measured: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)

  9. 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.

    Measured: At Year 1, Year 3, Year 5

  10. 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.

    Measured: At Year 1, Year 3, Year 5

  11. 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.

    Measured: At Year 1, Year 3, Year 5

  12. 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.

    Measured: At Year 1, Year 3, Year 5

  13. 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.

    Measured: 1 month after administration of Prevnar 13 (i.e. at Month 1)

  14. 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.

    Measured: 1 month after administration of Prevnar 13 (i.e. at Month 1)

  15. 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.

    Measured: 1 month after administration of Prevnar 13 (i.e. at Month 1)

  16. 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.

    Measured: Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])

  17. 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.

    Measured: Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])

  18. 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.

    Measured: Within 31 days post any vaccination

  19. 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.

    Measured: Month 0 to Month 9

  20. 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.

    Measured: Baseline up to end of study (up to 5 years)

  21. 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.

    Measured: Month 0 to Month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2013 (estimated)
  2. Study start2 Oct 2013
  3. Primary completion5 Dec 2019
  4. Study completion5 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01939158
Sponsor's protocol ID
MENACWY-TT-104
Other IDs
C0921003, 2013-001083-28, 116892
Status last verified
Sep 2021
First submitted
29 Aug 2013
Last updated
5 Oct 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Cutland CL, Peyrani P, Webber C, Newton R, Cutler M, Perez JL. 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 Jan 27;41(5):1153-1160. doi: 10.1016/j.vaccine.2022.11.048. Epub 2023 Jan 6.

    PubMed 36621408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612 and Prevenar 13™ in people with Infections, Meningococcal, run by Pfizer at 51 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Czechia, Australia, Canada, Panama, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939158, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.

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