Who is sponsoring NCT00617760?

NCT00617760 is sponsored by Pfizer.

What drugs are being tested in NCT00617760?

Interventions in NCT00617760: Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7), Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT).

What condition does NCT00617760 study?

NCT00617760 studies Neisseria Meningitidis (Bacterial Meningitis), Invasive Pneumococcal Disease (IPD).

Is NCT00617760 still recruiting?

NCT00617760 is currently completed. Last updated 20 May 2015.

Last reviewed 2015-05-20 · How we verify

NCT00617760

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

Open-label, Randomized, 3-arm, Phase 3B Clinical Study to Investigate the Safety and Immunogenicity of a Concomitant Administration of Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate (MenC-TT) Vaccine and 7-valent Pneumococcal CRM197-conjugate Vaccine (PCV7) in Toddlers Previously Immunized During Infancy With PCV7

Completed Phase 3 Last updated 20 May 2015

What this trial tests

Phase 3 trial testing Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) in Neisseria Meningitidis (Bacterial Meningitis) in 330 participants. Completed in 1 December 2009.

Timeline

1 March 2008

Primary endpoint
1 August 2009

1 December 2009

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	330
Start date	1 March 2008
Primary completion	1 August 2009
Estimated completion	1 December 2009
Sites	27 locations across Germany

Drugs / interventions tested

Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) vaccine and 7-valent Pneumococcal CRM197-conjugate vaccine (PCV7)
7-valent Pneumococcal CRM197-conjugate vaccine (PCV7) — full drug profile →
Group C Meningococcal Polysaccharide-Tetansu Toxoid Conjugate (MenC-TT) — full drug profile →

Conditions studied

Neisseria Meningitidis (Bacterial Meningitis) — all drugs for Neisseria Meningitidis (Bacterial Meningitis) →
Invasive Pneumococcal Disease (IPD) — all drugs for Invasive Pneumococcal Disease (IPD) →

Sponsor

Pfizer — full company profile →

Who can join

Adults 12 Months to 18 Months, any sex, with Neisseria Meningitidis (Bacterial Meningitis) or Invasive Pneumococcal Disease (IPD). Healthy volunteers can join.

What's being measured

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

Number of subjects achieving PCV7-specific (elicited by each vaccine pneumococcal serotype) antibody concentrations of at least 0.2 mg/mL 1 month after a booster vaccination with PCV7
Time frame: 1 month after booster vaccination with PCV7
Number of subjects achieving sero-protective levels of meningococcal serogroup C (MenC) specific serum bactericidal activity (SBA), defined as titer >=1:8, 1 month after administration of MenC-TT vaccine
Time frame: 1 month after administration of MenC-TT vaccine

Sponsor's own description

The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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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 NCT00617760 (US National Library of Medicine, public domain)
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: 20 May 2015

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/NCT00617760.

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