Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Elderly Subjects

There is evidence that aluminum phosphate (AlPO4) contained as an adjuvant in conjugate vaccines enhances the immune response in infants. There is no data so far evaluating whether this also applies to adults. The objective of this study is to compare the immune response of 2 different 13-valent pneumococcal conjugate (13vPnC) formulations with and without AlPO4 to select a formulation and to compare the immune response to the chosen 13vPnC formulation relative to the immune response to 23-valent pneumococcal polysaccharide vaccine (23vPS).

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Key information

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male and female adults 65 years of age and older.
Determined by medical history, physical examination, and clinical judgment to be eligible for the study.
Expected to be available for the duration of the trial (up to approximately 13 months).

Exclusion criteria

Received previous immunization with 23vPS.
Serious chronic disorders including metastatic malignancy
Known or suspected hypersensitivity to any vaccine or vaccine components

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

Primary outcomes

Demonstrate 13vPnC without AlPO4 is as immunogenic as 13vPnC with AlPO4 to select a 13vPnC formulation.

Secondary outcomes

Demonstrate that the selected 13vPnC formulation is as immunogenic as 23vPS (by IgG).
Safety and tolerability of the selected 13vPnC formulation given 12 months after a previous dose of the selected 13vPnC.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

A Randomized, Open Label, Controlled Phase II Study to Evaluate Safety, Tolerability and Immunogenicity After Two Different 13-Valent Pneumococcal Conjugate Vaccine Formulations in Elderly Subjects Aged 65 Years and Older Who Are Naive to Previous 23vPS Immunization

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Dec 23, 2005
Registry last updated: Aug 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed