NCT01939158|CompletedPhase 3ResultsFDA Drug

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

Pfizer ClinicalTrials.gov

Compare

4 other identifiers

MENACWY-TT-104C09210032013-001083-28116892

Study Type

interventional

Target

803

Locations

6 countries

Sites

Timeline

RegisteredSep 2013

StartedOct 2013

CompletionDec 2019

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

803

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach

6 countries

51 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.2 years study duration

First Submitted

Initial submission to the registry

August 29, 2013

Completed

13 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed

21 days until next milestone

Study Start

First participant enrolled

October 2, 2013

Completed

6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2019

Completed

1.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2021

Completed

Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

6.2 years

First QC Date

August 29, 2013

Results QC Date

September 7, 2021

Last Update Submit

September 7, 2021

Conditions

Infections, Meningococcal

Keywords

Co-administrationSafetyPersistenceImmunogenicityPrevenar 13Meningococcal vaccineToddlers5 years

Outcome Measures

Primary Outcomes (9)

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 Outcomes (21)

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
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
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
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
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
1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)
+16 more secondary outcomes

Study Arms (4)

ACWY1d group

EXPERIMENTAL

Subjects will receive 1 dose of the MenACWY-TT vaccine

Biological: Meningococcal vaccine GSK134612

ACWY2d group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612

Co-ad group

EXPERIMENTAL

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

Biological: Meningococcal vaccine GSK134612Biological: Prevenar 13™

PCV-13 group

ACTIVE COMPARATOR

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

Biological: Meningococcal vaccine GSK134612Biological: Prevenar 13™

Interventions

Meningococcal vaccine GSK134612BIOLOGICAL

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

ACWY1d groupACWY2d groupCo-ad groupPCV-13 group

Prevenar 13™BIOLOGICAL

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

Co-ad groupPCV-13 group

Eligibility Criteria

Age12 Months - 14 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (51)

Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

The Childrens Hospital at Westmead

Westmead, New South Wales, 2145, Australia

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Vaccine and Immunization Research Group

Melbourne, Victoria, 3010, Australia

Location

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

Nedlands, Western Australia, 6009, Australia

Location

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

Winnipeg, Manitoba, R3E 3P4, Canada

Location

Canadian Center for Vaccinology - IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Medicor Research Inc.

Greater Sudbury, Ontario, P3A 1W8, Canada

Location

Dr. Allen Greenspoon Medicine Professional Corporation

Hamilton, Ontario, L8L 5G8, Canada

Location

CHU de Quebec-Universite Laval

Québec, Quebec, G1E 7G9, Canada

Location

Medicentrum 6 s.r.o

Prague, Vokovice, 160 00, Czechia

Location