CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 962 enrolled
Drug / intervention
Blood draw +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT01025336
NCT01025336Phase 3Completed

A Study To Evaluate The Persistence Of The Antibody Response Elicited By 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Adults Who Have Previously Been Vaccinated With Either 2 Doses Of 13vPnC Or 13vPnC And 23-Valent Pneumococcal Polysaccharide Vaccine In Different Sequential Order In Study 6115A1-3010 Or 6115A1 3005

Pfizer·interventional·Posted Dec 3, 2009·Updated Jun 20, 2012

In Brief

A Phase 3 clinical trial evaluating Blood draw for Healthy. Completed, enrolled 962 participants across 29 sites.

Detailed Summary

The purpose of this study is to evaluate the levels of antibodies 1 year after receiving the second vaccine dose in two groups of adults over the age of 60: (1) those who have previously received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) and (2) those who have previously received 1 dose of 13vPnc and 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). This study will also assess whether the use of the 2 vaccines, 13vPnC and 23vPS, administered in different sequential order results in different prolonged antibody levels. This study is limited to individuals who participated in either study 6115A1-3010 (NCT00574548) or 6115A1-3005 (NCT00546572).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 3, 2009
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.6 years ago

Interventions

Blood drawother

Group 1.1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1 Group 1.2- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 1

Blood drawother

Group 1- 0.5 mL dose of 13vPnC was administered in the deltoid muscle at year 0 and year 1 Group 2- 0.5 mL dose of 23vPS was administered in the deltoid muscle at year 0 and 0.5 mL dose of 13vPNC was administered in the deltoid muscle at year 1