Clinical trial NCT01939158: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections, Meningococcal
Keywords: Co-administration
Safety
Persistence
Immunogenicity
Prevenar 13
Meningococcal vaccine
Toddlers
5 years
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 803
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
measure: Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group
timeFrame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
measure: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 1
measure: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 1
measure: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 3
measure: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 3
measure: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 5
measure: Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 5
measure: 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
timeFrame: 1 month after administration of Prevnar 13 (i.e. at Month 1)
Secondary outcomes:
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
measure: 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
timeFrame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
measure: 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
timeFrame: 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
measure: 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
timeFrame: 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)
measure: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups
timeFrame: At Year 1, Year 3, Year 5
measure: 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
timeFrame: At Year 1, Year 3, Year 5
measure: 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
timeFrame: At Year 1, Year 3, Year 5
measure: 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
timeFrame: At Year 1, Year 3, Year 5
measure: 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
timeFrame: 1 month after administration of Prevnar 13 (i.e. at Month 1)
measure: 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
timeFrame: 1 month after administration of Prevnar 13 (i.e. at Month 1)
measure: 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
timeFrame: 1 month after administration of Prevnar 13 (i.e. at Month 1)
measure: Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination
timeFrame: Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])
measure: Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination
timeFrame: Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])
measure: Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)
timeFrame: Within 31 days post any vaccination
measure: Number of Participants With Serious Adverse Events From Month 0 to Month 9
timeFrame: Month 0 to Month 9
measure: Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study
timeFrame: Baseline up to end of study (up to 5 years)
measure: Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9
timeFrame: Month 0 to Month 9
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Westmead
country: Australia
facility: The Childrens Hospital at Westmead
state: New South Wales
city: North Adelaide
country: Australia
facility: Women's and Children's Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Vaccine and Immunization Research Group
state: Victoria
city: Nedlands
country: Australia
facility: Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital
state: Western Australia
city: Winnipeg
country: Canada
facility: The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM]
state: Manitoba
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology - IWK Health Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Dr. Allen Greenspoon Medicine Professional Corporation
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc.
state: Ontario
city: Quebec City
country: Canada
facility: CHU de Quebec-Universite Laval
state: Quebec
city: Praha 6
country: Czechia
facility: Medicentrum 6 s.r.o
state: Vokovice
city: Benesov
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Boletice nad Labem
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Brandys nad Labem
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Caslav
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Chrastava
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Chrudim 2
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Decin
country: Czechia
facility: Krajska zdravotni, a.s., Nemocnice Decin
city: Domazlice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Holice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradec Kralove
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hradek nad Nisou
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Hronov
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Jindrichuv Hradec
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Kladno
country: Czechia
facility: Ordinace Praktickeho Lekare Pro Deti A Dorost
city: Krupka
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Liberec 7
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Melnik
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Nachod
country: Czechia
facility: Oblastni nemocnice Nachod
city: Neveklov
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Novy Jicin
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Odolena Voda
country: Czechia
facility: Ordinace Praktickeho Lekare pro deti a dorost
city: Ostrov Nad Ohri
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Ostrov
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Pardubice
country: Czechia
facility: Nemocnice Pardubice
city: Praha 3
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Praha 5
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Smirice
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Trutnov
country: Czechia
facility: Ordinace Praktickeho Lekare pro deti a dorost
city: Tynec nad Sazavou
country: Czechia
facility: Ordinace praktickeho lekare pro deti a dorost
city: Panama
country: Panama
facility: Centro Pediatrico America, Consultorios America
city: Panama
country: Panama
facility: CEVAXIN Plaza Carolina
city: Panama
country: Panama
facility: Consultorios America Via Espana
city: Panama
country: Panama
facility: ULAPS Guadalupe
city: Soweto
country: South Africa
facility: Chris Hani Baragwanath Academic Hospital
state: Gauteng
city: Gauteng
country: South Africa
facility: Setshaba Clinical Research
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Medicine
state: Sihhiye
city: Izmir
country: Turkey
facility: Ege University Hospital Medical Faculty
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: