Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)

A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00560950

Enrollment

143

Registered

2007-11-20

Start date

2007-07-31

Completion date

2008-05-31

Last updated

2017-04-11

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

Conditions

Pneumococcal Infection

Brief summary

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

Detailed description

This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Interventions

BIOLOGICALpneumococcal 23v polysaccharide vaccine

Duration of Treatment: Single vaccination on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

59 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Postmenopausal or negative urine pregnancy test if female * No fever on the day of vaccination

Exclusion criteria

* History of allergy to vaccine components * History of pneumococcal disease * Received any live virus vaccination within 4 weeks prior to study start * Received any inactivated vaccination within 7 days prior to study start * Received any blood products within 5 months prior to study start * Participated in an investigational drug or vaccine study in the past 30 days * Received immunosuppressive therapy * Patient has an immune deficiency

Design outcomes

Primary

Measure	Time frame	Description
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F	Day 1 & Day 30	Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Participant flow

Recruitment details

This was a Phase III study. The first patient was enrolled (FPE) on 13-Jul-2007. The last patient last visit (LPLV) was on 30-May-2008. A total of 5 US study centers were involved in the recruitment.

Pre-assignment details

Base trial 4/97-4/98 Prior to results posted Initial: subjects received 1st or 2nd dose of PN23 Persistence: followed immune response 5 yrs; ended 4/03 Extension 7/07-4/08: enrolled 9-10 yrs after base. 1dose of PN23 Blood drawn Days 1&30, immune response to 8 serotypes measured 143 of 400 enrolled: difficulty enrolling eligible/interested subjects

Participants by arm

Arm	Count
1st Revaccination Group Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase	72
2nd Revaccination Group Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase	71
Total	143

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	0

Baseline characteristics

Characteristic	1st Revaccination Group	2nd Revaccination Group	Total
Age, Continuous	74.6 years	77.1 years	75.8 years
Sex: Female, Male Female	45 Participants	45 Participants	90 Participants
Sex: Female, Male Male	27 Participants	26 Participants	53 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	48 / —	60 / —
serious Total, serious adverse events	0 / 71	0 / 71

Outcome results

Primary

Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F

Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA.

Time frame: Day 1 & Day 30