NCT01962207 is a Phase 3 clinical trial of Meningococcal vaccine GSK134612 in Infections, Meningococcal, sponsored by Pfizer.

Who is sponsoring NCT01962207?

NCT01962207 is sponsored by Pfizer.

What drugs are being tested in NCT01962207?

Interventions in NCT01962207: Meningococcal vaccine GSK134612.

What condition does NCT01962207 study?

NCT01962207 studies Infections, Meningococcal.

Is NCT01962207 still recruiting?

NCT01962207 is currently completed. Last updated 4 March 2019.

Are results published for NCT01962207?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-03-04 · How we verify

NCT01962207

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A PHASE IIIB, OPEN, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 6, 7, 8, 9 AND 10 YEARS AFTER THE ADMINISTRATION OF ONE DOSE OF THE MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF MENINGITEC(REGISTERED) VACCINE OR ONE DOSE OF THE MENINGOCOCCAL POLYSACCHARIDE VACCINE MENCEVAX(REGISTERED) ACWY, AND TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER PRIMARY VACCINATION OF 1-10 YEAR OLD SUBJECTS WITH MENACWY-TT, MENINGITEC(REGISTERED) OR MENCEVAX(REGISTERED) ACWY.

Completed Phase 3 Results posted Last updated 4 March 2019

What this trial tests

Phase 3 trial testing Meningococcal vaccine GSK134612 in Infections, Meningococcal in 243 participants. Completed in 1 June 2018.

Timeline

1 October 2013

Primary endpoint
1 December 2017

1 June 2018

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	243
Start date	1 October 2013
Primary completion	1 December 2017
Estimated completion	1 June 2018
Sites	9 locations across Finland

Drugs / interventions tested

Meningococcal vaccine GSK134612 — full drug profile →

Conditions studied

Infections, Meningococcal — all drugs for Infections, Meningococcal →

Sponsor

Pfizer — full company profile →

Who can join

Eligibility, any sex, with Infections, Meningococcal. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
Time frame: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100)
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).
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
Time frame: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
Serogroups included MenA, MenC, MenW-135 and MenY.
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
Time frame: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
Serogroups included MenA, MenC, MenW-135 and MenY.
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
Time frame: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Serogroups included MenA, MenC, MenW-135 and MenY.
Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
Time frame: 10 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Serogroups included MenA, MenC, MenW-135 and MenY.
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Time frame: 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)
Serogroups included MenA, MenC, MenW-135 and MenY.

Sponsor's own description

The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age.
Vesikari T, Peyrani P, Webber C, Van Der Wielen M, et al · · 2020 · cited 15× · PMID 32598244 · DOI 10.1080/21645515.2020.1746110

Verify or expand the search:

Other trials of Meningococcal vaccine GSK134612

Trials testing the same drug.

NCT01939158 — Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT · Phase 3 · completed
NCT01755689 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administr · Phase 3 · completed
NCT01767376 — Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When C · Phase 3 · completed
NCT01641042 — Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subje · Phase 3 · completed
NCT00955682 — Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK134612 · Phase 3 · completed

Other Pfizer trials

Trials by the same sponsor.

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NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01962207 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 4 March 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01962207.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing