MedTrace Logo

Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

NCT01215175 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2019-03-18

Study results available
· View outcomes & findings →

Summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Prevnar™

13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

BIOLOGICAL

V114, Aluminum Adjuvanted

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.

BIOLOGICAL

V114, Aluminum Nonadjuvanted

15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-25
Primary Completion
2010-04-16
Completion
2011-01-05

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01215175 on ClinicalTrials.gov