Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00164411

Enrollment

Registered

2005-09-14

Start date

2004-01-31

Completion date

2005-03-31

Last updated

2012-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

Keywords

Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity

Brief summary

The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination (tetanus shot) before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.

Detailed description

The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults. In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults: * Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23 * PCV7, 4-month interval, PPV23 * PPV23 We aim to: * compare the safety profiles of pneumococcal vaccines given on each of the three schedules * compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules * compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules * study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens

Interventions

BIOLOGICALTetanus-diphtheria toxoids (Td)

BIOLOGICAL7-valent pneumococcal conjugate vaccine

BIOLOGICAL23-valent polysaccharide vaccine

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 64 Years

Healthy volunteers

Yes

Exclusion criteria

* Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start * Any vaccination within 2 weeks prior to first study vaccine * Evidence of systemic or local infection within one week prior to first study vaccine * HIV infection * Renal failure * Receipt of a pneumococcal or Td vaccine within 5 years * Current receipt of therapy for neoplastic disease * Current receipt of immunosuppressive therapy * Terminal illness withlife expectancy less than 3 months

Design outcomes

Primary

Measure	Time frame
ELISA for S. pneumoniae antibody 2 months after receiving PPV23	—
Functional S. pneumoniae antibody 2 months after receiving PPV23	—

Secondary

Measure	Time frame
Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026