NCT00496093

Brief Summary

To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
133

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_3

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

October 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2007

Completed
Last Updated

March 14, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

July 3, 2007

Last Update Submit

March 13, 2017

Conditions

Pneumococcal Infection

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects exhibiting a >= 2 fold increase in IGG antibody level from pre-vaccination to post-vaccination for both serotypes 1 and 6b

    post-vaccination

Secondary Outcomes (1)

  • Any AE within 15 days after vaccination, with particular attention to injection site AE and fever

    15 days after vaccination

Study Arms (1)

Pneumococcal Vaccine, Polyvalent (23-valent)

EXPERIMENTAL

Participants received one 0.5 mL dose of Pneumococcal Vaccine, Polyvalent (23-valent) by intramuscular (deltoid) injection on Day 1.

Biological: Pneumococcal Vaccine, Polyvalent (23-valent)

Interventions

Pneumococcal Vaccine, Polyvalent (23-valent)BIOLOGICAL
Also known as: V110, PNEUMOVAX™ 23
Pneumococcal Vaccine, Polyvalent (23-valent)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy indian adults of 50 years of age
  • In good health; any underlying chronic illness must be documented to be in stable condition
  • Signed and dated informed consent prior to receipt of the study vaccine

You may not qualify if:

  • Functional or anatomic asplenia
  • History of auto immune disease
  • Hypersensitivity to any of the components of the study vaccine,including phenol
  • Known or suspected immune dysfunction, including persons with congenital immunodeficiency
  • Prior vaccination with any pneumococcal vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

Pneumococcal Vaccines2,4,5,4'-tetrachlorodiphenylsulfoxide

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
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2007

First Posted

July 4, 2007

Study Start

October 1, 2005

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

March 14, 2017

Record last verified: 2017-03