NCT00127153

Brief Summary

The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an investigational pneumococcal vaccine in healthy adults.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for phase_3 healthy

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3 healthy

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

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2005

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

2 months

First QC Date

August 2, 2005

Last Update Submit

January 28, 2015

Conditions

HealthyPneumococcal Infections

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity

Secondary Outcomes (1)

  • Safety

Interventions

V110, pneumococcal vaccine polyvalentBIOLOGICAL

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females in good health, ages 20-40, with no history of pneumococcal vaccination

You may not qualify if:

  • Subjects with a recent febrile illness
  • Known or suspected immune dysfunction, conditions associated with immunosuppression, and receipt of immunosuppressive chemotherapy, including long-term corticosteroid therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

2,4,5,4'-tetrachlorodiphenylsulfoxidePneumococcal Vaccines

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2005

First Posted

August 5, 2005

Study Start

March 1, 2005

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

January 29, 2015

Record last verified: 2015-01