A Phase 3 interventional study of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in Pneumococcal Vaccines and Pneumococcal Conjugate Vaccine, sponsored by Pfizer. Completed at 8 sites in Japan. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-20.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
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Biological: 13-valent pneumococcal conjugate vaccine
Biological: 23-valent pneumococcal polysaccharide vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Also known as: 13vPnC
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Also known as: 23VPS
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: One month after vaccination
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
Time frame: One month after vaccination
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: One month after vaccination
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination
Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
Time frame: Within 14 days after vaccination
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 37.5 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
Time frame: Within 14 days after vaccination
| Milestone | 13vPnC | 23vPS |
|---|---|---|
| Started | 382 | 382 |
| Completed | 381 | 382 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Antibody-mediated serum OPA against each of the 12 pneumococcal serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
| titer | 13vPnC | 23vPS |
|---|---|---|
| 1 (n=366, 366) | 103 (84.6 to 125.5) | 78 (63.6 to 95.8) |
| 3 (n=365, 367) | 44 (38.1 to 51.5) | 61 (52.8 to 70.1) |
| 4 (n=360, 362) | 1016 (850.7 to 1213.2) | 392 (314.7 to 487.1) |
| 5 (n=350, 361) | 347 (282.3 to 425.6) | 118 (98.4 to 142.5) |
| 6B (n=360, 359) | 1995 (1689.3 to 2355.9) | 1440 (1223.5 to 1694.2) |
| 7F (n=365, 364) | 1901 (1642.8 to 2198.7) | 1361 (1153.3 to 1605.6) |
| 9V (n=365,358) | 858 (675.7 to 1089.5) | 379 (290.2 to 493.9) |
| 14 (n=363, 359) | 1028 (866.9 to 1217.9) | 1059 (896.6 to 1250.6) |
| 18C (n=366, 362) | 2015 (1675.4 to 2424.5) | 938 (752.7 to 1170.1) |
| 19A (n=365, 362) | 985 (841.5 to 1153.9) | 429 (358.0 to 513.2) |
| 19F (n=352, 357) | 773 (607.9 to 983.0) | 388 (305.6 to 491.8) |
| 23F (n=366, 363) | 456 (363.7 to 570.6) | 180 (143.1 to 226.1) |
For serotype 6A the percentage of participants achieving at least a 4-fold rise on the serotype-specific antibody titer from pre-vaccination to 1 month post-vaccination was computed along with exact, 2-sided 95% confidence interval for the proportion.
| percentage of participants | 13vPnC | 23vPS |
|---|---|---|
| Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination | 74.0 (68.8 to 78.7) | 47.2 (41.6 to 52.8) |
Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolonoy OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
| titer | 13vPnC | 23vPS |
|---|---|---|
| 1 (n=366, 366) | 103 (84.6 to 125.5) | 78 (63.6 to 95.8) |
| 3 (n=365, 367) | 44 (38.1 to 51.5) | 61 (52.8 to 70.1) |
| 4 (n=360, 362) | 1016 (850.7 to 1213.2) | 392 (314.7 to 487.1) |
| 5 (n=350, 361) | 347 (282.3 to 425.6) | 118 (98.4 to 142.5) |
| 6B (n=360, 359) | 1995 (1689.3 to 2355.9) | 1440 (1223.5 to 1694.2) |
| 7F (n=365, 364) | 1901 (1642.8 to 2198.7) | 1361 (1153.3 to 1605.6) |
| 9V (n=365,358) | 858 (675.7 to 1089.5) | 379 (290.2 to 493.9) |
| 14 (n=363, 359) | 1028 (866.9 to 1217.9) | 1059 (896.6 to 1250.6) |
| 18C (n=366, 362) | 2015 (1675.4 to 2424.5) | 938 (752.7 to 1170.1) |
| 19A (n=365, 362) | 985 (841.5 to 1153.9) | 429 (358.0 to 513.2) |
| 19F (n=352, 357) | 773 (607.9 to 983.0) | 388 (305.6 to 491.8) |
| 23F (n=366, 363) | 456 (363.7 to 570.6) | 180 (143.1 to 226.1) |
| 6A (n=360, 349) | 2122 (1790.9 to 2515.2) | 676 (542.4 to 841.7) |
Local reactions reported using an electronic diary. Redness and swelling scaled as Any (redness present or swelling present); Mild (2.5 to 5.0 centimeters \[cm\]; Moderate (5.1 to 10.0 cm); Severe (\>10 cm). Pain scaled as Any (pain present); Mild (awareness of pain; easily tolerated); Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating). Limitation of arm movement scaled as Any (limitation present); Mild (some limitation); Moderate (unable to move arm above head; able to move arm above shoulder); Severe (unable to move arm above shoulder).
| percentage of participants | 13vPnC | 23vPS |
|---|---|---|
| Redness: Any (n=355, 363) | 28.7 (24.1 to 33.7) | 10.5 (7.5 to 14.1) |
| Redness: Mild (n=352, 362) | 22.2 (17.9 to 26.9) | 7.7 (5.2 to 11.0) |
| Redness: Moderate (n=353, 360) | 17.3 (13.5 to 21.6) | 3.9 (2.1 to 6.4) |
| Redness: Severe (n=349, 359) | 3.4 (1.8 to 5.9) | 0.3 (0.0 to 1.5) |
| Swelling: Any (n=353, 360) | 21.5 (17.4 to 26.2) | 6.7 (4.3 to 9.8) |
| Swelling: Mild (n=351, 360) | 16.5 (12.8 to 20.8) | 5.0 (3.0 to 7.8) |
| Swelling: Moderate (n=351, 359) | 9.7 (6.8 to 13.3) | 2.5 (1.2 to 4.7) |
| Swelling: Severe (n=349, 359) | 1.4 (0.5 to 3.3) | 0.3 (0.0 to 1.5) |
| Pain: Any (n=362, 368) | 45.6 (40.4 to 50.9) | 38.3 (33.3 to 43.5) |
| Pain: Mild (n=362, 368) | 45.3 (40.1 to 50.6) | 37.5 (32.5 to 42.7) |
| Pain: Moderate (n=349, 361) | 2.9 (1.4 to 5.2) | 5.5 (3.4 to 8.4) |
| Pain: Severe (n=348, 359) | 0.0 (0.0 to 1.1) | 1.4 (0.5 to 3.2) |
| Limitation of arm movement: Any (n=355, 362) | 16.3 (12.6 to 20.6) | 16.9 (13.1 to 21.1) |
| Limitation of arm movement: Mild (n=355, 361) | 15.5 (11.9 to 19.7) | 15.8 (12.2 to 20.0) |
| Limitation of arm movement: Moderate(n=348, 360) | 1.1 (0.3 to 2.9) | 3.6 (1.9 to 6.1) |
| Limitation of arm movement: Severe (n=348, 359) | 0.3 (0.0 to 1.6) | 1.7 (0.6 to 3.6) |
Systemic events reported using an electronic diary. Systemic events are any fever greater than or equal to (\>=) 37.5 degrees Celsius \[C\], fatigue, headache, chills, rash, vomiting, decreased appetite, new muscle pain, aggravated muscle pain, new joint pain, aggravated joint pain, use of medication to treat fever and use of medication to treat pain. All reports of fever \>=39 degrees C in 13vPnC and 23vPS were confirmed as data entry errors.
| percentage of participants | 13vPnC | 23vPS |
|---|---|---|
| Fever >=37.5 to <38.5 degrees C (n=348, 359) | 2.6 (1.2 to 4.9) | 2.8 (1.3 to 5.1) |
| Fever >=38.5 to <39 degrees C (n=348, 359) | 0.3 (0.0 to 1.6) | 0.3 (0.0 to 1.5) |
| Fever >=39 to <=40 degrees C (n=348, 359) | 0.0 (0.0 to 1.1) | 0.6 (0.1 to 2.0) |
| Fever >40 degrees C (n=348, 359) | 0.9 (0.2 to 2.5) | 0.0 (0.0 to 1.0) |
| Fatigue (n=352, 362) | 17.3 (13.5 to 21.7) | 16.0 (12.4 to 20.2) |
| Headache (n=351, 361) | 9.4 (6.6 to 12.9) | 11.6 (8.5 to 15.4) |
| Chills (n=348, 359) | 2.9 (1.4 to 5.2) | 1.1 (0.3 to 2.8) |
| Rash (n=350, 359) | 8.9 (6.1 to 12.3) | 3.6 (1.9 to 6.1) |
| Vomiting (n=348, 359) | 1.1 (0.3 to 2.9) | 0.6 (0.1 to 2.0) |
| Decreased appetite (n=348, 360) | 3.7 (2.0 to 6.3) | 5.0 (3.0 to 7.8) |
| New muscle pain (n=354, 362) | 18.4 (14.5 to 22.8) | 17.4 (13.6 to 21.7) |
| Aggravated muscle pain (n=350, 359) | 4.0 (2.2 to 6.6) | 3.9 (2.1 to 6.5) |
| New joint pain (n=350, 359) | 7.7 (5.1 to 11.0) | 7.0 (4.6 to 10.1) |
| Aggravated joint pain (n=349, 359) | 2.9 (1.4 to 5.2) | 3.1 (1.5 to 5.4) |
| Use of medication to treat fever (n=348, 360) | 0.9 (0.2 to 2.5) | 2.2 (1.0 to 4.3) |
| Use of medication to treat pain (n=348, 360) | 1.1 (0.3 to 2.9) | 2.8 (1.3 to 5.0) |
Collected over AEs/SAEs: recorded from signing of informed consent form to completion of study. Participants recorded pre-specified AEs in electronic diary:local reactions; systemic events; use of antipyretic medication (up to 14 days after vaccination).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 13vPnC | — | 1/382 (0.3%) | 211/382 (55.2%) |
| 23vPS | — | 0/382 (0%) | 166/382 (43.5%) |
| Event | 13vPnC | 23vPS |
|---|---|---|
| Pancreatic carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/382 | 0/382 |
| Event | 13vPnC | 23vPS |
|---|---|---|
| Pain (Any)Skin and subcutaneous tissue disorders | 165/362 | 141/368 |
| Pain (Mild)Skin and subcutaneous tissue disorders | 164/362 | 138/368 |
| Redness (Any)Skin and subcutaneous tissue disorders | 102/355 | 38/363 |
| Redness (Mild)Skin and subcutaneous tissue disorders | 78/352 | 28/362 |
| Swelling (Any)Skin and subcutaneous tissue disorders | 76/353 | 24/360 |
| New muscle painGeneral disorders | 65/354 | 63/362 |
| FatigueGeneral disorders | 61/352 | 58/362 |
| Redness (Moderate)Skin and subcutaneous tissue disorders | 61/353 | 14/360 |
| Limitation of arm movement (Any)Skin and subcutaneous tissue disorders | 58/355 | 61/362 |
| Swelling (Mild)Skin and subcutaneous tissue disorders | 58/351 | 18/360 |
| Age Continuous(years) | 13vPnC | 23vPS | Total |
|---|---|---|---|
| Mean | 70.0 ± 4.08 | 69.7 ± 3.66 | 69.9 ± 3.87 |
| Sex: Female, Male(Participants) | 13vPnC | 23vPS | Total |
|---|---|---|---|
| Female | 198 | 187 | 385 |
| Male | 184 | 195 | 379 |
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Studies of the drug tested here: 13-valent pneumococcal vaccine