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

NCT ID: NCT01939158

Last Updated: 2021-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-02
• Study Completion Date: 2019-12-05

Brief Summary

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

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.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ACWY1d group

Subjects will receive 1 dose of the MenACWY-TT vaccine

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

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

ACWY2d group

Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

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

Co-ad group

Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™

Group Type: EXPERIMENTAL

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

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

Prevenar 13™

Intervention Type: BIOLOGICAL

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

PCV-13 group

Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later

Group Type: ACTIVE_COMPARATOR

Meningococcal vaccine GSK134612

Intervention Type: BIOLOGICAL

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

Prevenar 13™

Intervention Type: BIOLOGICAL

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

Interventions

Meningococcal vaccine GSK134612

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

Intervention Type: BIOLOGICAL

Prevenar 13™

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
• Previous vaccination against Neisseria meningitidis.
• Previous booster vaccination against Streptococcus pneumoniae.
• Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
• History of meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*

• Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
• Acute disease and/or fever at the time of enrollment.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Canberra Hospital

Garran, Australian Capital Territory, Australia

The Childrens Hospital at Westmead

Westmead, New South Wales, Australia

Women's and Children's Hospital

North Adelaide, South Australia, Australia

Vaccine and Immunization Research Group

Melbourne, Victoria, Australia

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

Nedlands, Western Australia, Australia

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

Winnipeg, Manitoba, Canada

Canadian Center for Vaccinology - IWK Health Centre

Halifax, Nova Scotia, Canada

Medicor Research Inc.

Greater Sudbury, Ontario, Canada

Dr. Allen Greenspoon Medicine Professional Corporation

Hamilton, Ontario, Canada

CHU de Quebec-Universite Laval

Québec, Quebec, Canada

Medicentrum 6 s.r.o

Prague, Vokovice, Czechia

Ordinace praktickeho lekare pro deti a dorost

Benešov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Boletice nad Labem, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Brandýs nad Labem, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Chrastava, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Chrudim, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Čáslav, , Czechia

Krajska zdravotni, a.s., Nemocnice Decin

Děčín, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Domažlice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Holice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Hradec Králové, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Hrádek nad Nisou, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Hronov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, , Czechia

Ordinace Praktickeho Lekare Pro Deti A Dorost

Kladno, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Krupka, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Liberec, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Mělník, , Czechia

Oblastni nemocnice Nachod

Náchod, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Neveklov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Nový Jičín, , Czechia

Ordinace Praktickeho Lekare pro deti a dorost

Odolena Voda, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Ostrov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Ostrov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Pardubice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Pardubice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Pardubice, , Czechia

Nemocnice Pardubice

Pardubice, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Prague, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Prague, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Smiřice, , Czechia

Ordinace Praktickeho Lekare pro deti a dorost

Trutnov, , Czechia

Ordinace praktickeho lekare pro deti a dorost

Týnec nad Sázavou, , Czechia

Centro Pediatrico America, Consultorios America

Panama City, , Panama

CEVAXIN Plaza Carolina

Panama City, , Panama

Consultorios America Via Espana

Panama City, , Panama

ULAPS Guadalupe

Panama City, , Panama

Chris Hani Baragwanath Academic Hospital

Soweto, Gauteng, South Africa

Setshaba Clinical Research

Gauteng, , South Africa

Hacettepe University Faculty of Medicine

Ankara, Sihhiye, Turkey (Türkiye)

Ege University Hospital Medical Faculty

Izmir, , Turkey (Türkiye)

Countries

Australia; Canada; Czechia; Panama; South Africa; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 36621408 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=MENACWY-TT-104&StudyName=A+Phase+Iii%2C+Randomised%2C+Open%2C+Controlled%2C+Multicentre%2C+Primary+Vaccination+Study+To+Evaluate+The+Immunogenicity+And+Persistence+Of+1+And+2+Doses+Of+Meningococcal+Conjugate+Vaccine+Menacwy-tt+In+Toddlers+%28after+1+Month+And+Up+To+5+Years%29+And+To+Demonstrate+Non-inferiority+Of+Co-administration+Of+Menacwy-tt+And+13-valent+Pneumococcal+Conjugate+Vaccine+Prevenar+13%28registered%29+Versus+Separate+Administration+Of+The+2+Vaccines

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

Other Identifiers

C0921003

Identifier Type: OTHER

Identifier Source: secondary_id

2013-001083-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

116892

Identifier Type: OTHER

Identifier Source: secondary_id

MENACWY-TT-104

Identifier Type: -

Identifier Source: org_study_id