Trial Outcomes & Findings for Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older (NCT NCT00741039)

Results Overview

For Pneumovax, complete response will be either seroconversion or a \>3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

8-16 weeks following vaccination.

Results posted on

2015-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Adult Cancer Patients 65 Years of Age and Older Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older	Healthy Volunteers Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
Overall Study STARTED	102	25
Overall Study COMPLETED	100	25
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Adult Cancer Patients 65 Years of Age and Older Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older	Healthy Volunteers Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
Overall Study Patient non-compliance	2	0

Baseline Characteristics

Prospective Trial of Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adult Cancer Patients 65 Years of Age and Older n=102 Participants Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older	Healthy Volunteers n=25 Participants Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older	Total n=127 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	99 Participants n=5 Participants	25 Participants n=7 Participants	124 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	13 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	12 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8-16 weeks following vaccination.

For Pneumovax, complete response will be either seroconversion or a \>3 fold rise in titer against at least 5 of the following serotypes contained in Pneumovax (serotypes 4, 14, 19, 23, 6B, 18C, and 9V).

Outcome measures

Outcome measures
Measure	Adult Cancer Patients 65 Years of Age and Older n=100 Participants Vaccine Responses Against Pneumococcus and Influenza in Adult Cancer Patients 65 Years of Age and Older	Healthy Volunteers n=25 Participants Vaccine Responses Against Pneumococcus and Influenza in Adults 65 Years of Age and Older
Determine Response Rate of Patients > or = to 65 Yrs Diagnosed	63 participants	24 participants

Adverse Events

Adult Cancer Patients 65 Years of Age and Older

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Susan Seo

Memorial Sloan Kettering Cancer Center

Phone: 212-639-3151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place