Trial Outcomes & Findings for Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007) (NCT NCT00560950)
NCT ID: NCT00560950
Last Updated: 2017-04-11
Results Overview
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.
COMPLETED
PHASE3
143 participants
Day 1 & Day 30
2017-04-11
Participant Flow
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.
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
Participant milestones
| Measure |
1st Revaccination Group
Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
|
2nd Revaccination Group
Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
71
|
|
Overall Study
COMPLETED
|
71
|
71
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
1st Revaccination Group
Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
|
2nd Revaccination Group
Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)
Baseline characteristics by cohort
| Measure |
1st Revaccination Group
n=72 Participants
Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
|
2nd Revaccination Group
n=71 Participants
Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
|
Total
n=143 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.6 years
n=5 Participants
|
77.1 years
n=7 Participants
|
75.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3
|
0.6 gpELISA units/mL
Interval 0.5 to 0.8
|
1.4 gpELISA units/mL
Interval 1.1 to 1.8
|
0.7 gpELISA units/mL
Interval 0.5 to 0.8
|
1.2 gpELISA units/mL
Interval 0.9 to 1.6
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4
|
1.1 gpELISA units/mL
Interval 0.8 to 1.5
|
3.0 gpELISA units/mL
Interval 2.2 to 3.9
|
1.7 gpELISA units/mL
Interval 1.4 to 2.2
|
3.0 gpELISA units/mL
Interval 2.2 to 4.0
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B
|
2.0 gpELISA units/mL
Interval 1.5 to 2.7
|
4.6 gpELISA units/mL
Interval 3.3 to 6.4
|
3.0 gpELISA units/mL
Interval 2.2 to 4.2
|
5.2 gpELISA units/mL
Interval 3.6 to 7.5
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8
|
3.0 gpELISA units/mL
Interval 2.4 to 3.7
|
9.3 gpELISA units/mL
Interval 7.4 to 11.8
|
3.4 gpELISA units/mL
Interval 2.7 to 4.4
|
7.4 gpELISA units/mL
Interval 5.8 to 9.3
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V
|
2.7 gpELISA units/mL
Interval 2.0 to 3.6
|
7.2 gpELISA units/mL
Interval 5.7 to 9.1
|
4.1 gpELISA units/mL
Interval 3.2 to 5.4
|
8.0 gpELISA units/mL
Interval 6.0 to 10.7
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F
|
0.4 gpELISA units/mL
Interval 0.3 to 0.6
|
1.5 gpELISA units/mL
Interval 1.0 to 2.1
|
0.8 gpELISA units/mL
Interval 0.6 to 1.2
|
1.5 gpELISA units/mL
Interval 1.0 to 2.2
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14
|
9.2 gpELISA units/mL
Interval 6.9 to 12.2
|
18.0 gpELISA units/mL
Interval 13.4 to 24.0
|
10.3 gpELISA units/mL
Interval 8.2 to 13.0
|
17.2 gpELISA units/mL
Interval 13.3 to 22.2
|
PRIMARY outcome
Timeframe: Day 1 & Day 30Population: All eligible participants
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.
Outcome measures
| Measure |
1st Revaccination Group Day 1
n=68 Participants
|
1st Revaccination Group Day 30
n=67 Participants
|
2nd Revaccination Group Day 1
n=67 Participants
|
2nd Revaccination Group Day 30
n=67 Participants
|
|---|---|---|---|---|
|
Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F
|
1.8 gpELISA units/mL
Interval 1.2 to 2.6
|
4.7 gpELISA units/mL
Interval 3.1 to 7.1
|
2.8 gpELISA units/mL
Interval 2.0 to 3.8
|
5.6 gpELISA units/mL
Interval 3.8 to 8.2
|
Adverse Events
1st Revaccination Group
2nd Revaccination Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1st Revaccination Group
n=71 participants at risk
Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
|
2nd Revaccination Group
n=71 participants at risk
Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/71
|
1.4%
1/71
|
|
Eye disorders
Dry Eye
|
0.00%
0/71
|
1.4%
1/71
|
|
Eye disorders
Lacrimation Increased
|
1.4%
1/71
|
0.00%
0/71
|
|
Eye disorders
Macular Degeneration
|
0.00%
0/71
|
1.4%
1/71
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/71
|
1.4%
1/71
|
|
Gastrointestinal disorders
Aphthous
|
1.4%
1/71
|
0.00%
0/71
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/71
|
1.4%
1/71
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/71
|
4.2%
3/71
|
|
Gastrointestinal disorders
Oral Disorder
|
1.4%
1/71
|
0.00%
0/71
|
|
General disorders
Anaesthesia
|
0.00%
0/71
|
1.4%
1/71
|
|
General disorders
Chills
|
1.4%
1/71
|
9.9%
7/71
|
|
General disorders
Coldness
|
0.00%
0/71
|
1.4%
1/71
|
|
General disorders
Erythema
|
19.7%
14/71
|
29.6%
21/71
|
|
General disorders
Fatigue
|
25.4%
18/71
|
38.0%
27/71
|
|
General disorders
Induration
|
0.00%
0/71
|
1.4%
1/71
|
|
General disorders
Oedema Peripheral
|
2.8%
2/71
|
0.00%
0/71
|
|
General disorders
Pain
|
25.4%
18/71
|
33.8%
24/71
|
|
General disorders
Pain (Injection site)
|
62.0%
44/71
|
74.6%
53/71
|
|
General disorders
Paraesthesia
|
0.00%
0/71
|
1.4%
1/71
|
|
General disorders
Peripheral Coldness
|
0.00%
0/71
|
1.4%
1/71
|
|
General disorders
Pruritus
|
2.8%
2/71
|
5.6%
4/71
|
|
General disorders
Pyrexia
|
1.4%
1/71
|
5.6%
4/71
|
|
General disorders
Swelling
|
19.7%
14/71
|
39.4%
28/71
|
|
General disorders
Warmth
|
2.8%
2/71
|
1.4%
1/71
|
|
Infections and infestations
Cystitis
|
1.4%
1/71
|
0.00%
0/71
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71
|
1.4%
1/71
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/71
|
1.4%
1/71
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/71
|
1.4%
1/71
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/71
|
1.4%
1/71
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/71
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
2/71
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Joint Range of Motion Decreased
|
1.4%
1/71
|
0.00%
0/71
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/71
|
2.8%
2/71
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
2.8%
2/71
|
1.4%
1/71
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/71
|
1.4%
1/71
|
|
Nervous system disorders
Headache
|
18.3%
13/71
|
25.4%
18/71
|
|
Nervous system disorders
Hypoaesthesia
|
1.4%
1/71
|
0.00%
0/71
|
|
Nervous system disorders
Migrane
|
0.00%
0/71
|
1.4%
1/71
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/71
|
1.4%
1/71
|
|
Psychiatric disorders
Insomnia
|
1.4%
1/71
|
0.00%
0/71
|
|
Psychiatric disorders
Restlessness
|
1.4%
1/71
|
0.00%
0/71
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
1/71
|
0.00%
0/71
|
|
Skin and subcutaneous tissue disorders
Pruritus Generalised
|
0.00%
0/71
|
1.4%
1/71
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER