Trial Outcomes & Findings for A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older (NCT NCT01646398)

Last Updated: 2013-09-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

764 participants

Primary outcome timeframe

One month after vaccination

Results posted on

2013-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Study STARTED	382	382
Overall Study COMPLETED	381	382
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC n=382 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=382 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.	Total n=764 Participants Total of all reporting groups
Age Continuous	70.0 years STANDARD_DEVIATION 4.08 • n=5 Participants	69.7 years STANDARD_DEVIATION 3.66 • n=7 Participants	69.9 years STANDARD_DEVIATION 3.87 • n=5 Participants
Sex: Female, Male Female	198 Participants n=5 Participants	187 Participants n=7 Participants	385 Participants n=5 Participants
Sex: Female, Male Male	184 Participants n=5 Participants	195 Participants n=7 Participants	379 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after vaccination

Population: Evaluable immunogenicity population:eligible participants, received study vaccine to which randomized, received no prohibited vaccines, had at least 1 valid and determinate assay result, had blood drawn within prescribed time frame and had no major protocol violations. n= number of participants with determinate OPA antibody titer to given serotype.

Outcome measures

Outcome measures
Measure	13vPnC n=366 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=367 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 1 (n=366, 366)	103 titer Interval 84.6 to 125.5	78 titer Interval 63.6 to 95.8
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 3 (n=365, 367)	44 titer Interval 38.1 to 51.5	61 titer Interval 52.8 to 70.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 4 (n=360, 362)	1016 titer Interval 850.7 to 1213.2	392 titer Interval 314.7 to 487.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 5 (n=350, 361)	347 titer Interval 282.3 to 425.6	118 titer Interval 98.4 to 142.5
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 6B (n=360, 359)	1995 titer Interval 1689.3 to 2355.9	1440 titer Interval 1223.5 to 1694.2
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 7F (n=365, 364)	1901 titer Interval 1642.8 to 2198.7	1361 titer Interval 1153.3 to 1605.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 9V (n=365,358)	858 titer Interval 675.7 to 1089.5	379 titer Interval 290.2 to 493.9
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 14 (n=363, 359)	1028 titer Interval 866.9 to 1217.9	1059 titer Interval 896.6 to 1250.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 18C (n=366, 362)	2015 titer Interval 1675.4 to 2424.5	938 titer Interval 752.7 to 1170.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 19A (n=365, 362)	985 titer Interval 841.5 to 1153.9	429 titer Interval 358.0 to 513.2
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 19F (n=352, 357)	773 titer Interval 607.9 to 983.0	388 titer Interval 305.6 to 491.8
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes 1 Month After Vaccination 23F (n=366, 363)	456 titer Interval 363.7 to 570.6	180 titer Interval 143.1 to 226.1

PRIMARY outcome

Timeframe: One month after vaccination

Population: Evaluable immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with determinate fold rise of OPA antibody titer to serotype 6A.

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.

Outcome measures

Outcome measures
Measure	13vPnC n=319 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=320 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Achieving At Least a 4-fold Rise in OPA Titers for Serotype 6A 1 Month After Vaccination	74.0 percentage of participants Interval 68.8 to 78.7	47.2 percentage of participants Interval 41.6 to 52.8

SECONDARY outcome

Timeframe: One 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).

Outcome measures

Outcome measures
Measure	13vPnC n=366 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=367 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 1 (n=366, 366)	103 titer Interval 84.6 to 125.5	78 titer Interval 63.6 to 95.8
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 3 (n=365, 367)	44 titer Interval 38.1 to 51.5	61 titer Interval 52.8 to 70.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 4 (n=360, 362)	1016 titer Interval 850.7 to 1213.2	392 titer Interval 314.7 to 487.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 5 (n=350, 361)	347 titer Interval 282.3 to 425.6	118 titer Interval 98.4 to 142.5
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 6B (n=360, 359)	1995 titer Interval 1689.3 to 2355.9	1440 titer Interval 1223.5 to 1694.2
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 7F (n=365, 364)	1901 titer Interval 1642.8 to 2198.7	1361 titer Interval 1153.3 to 1605.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 9V (n=365,358)	858 titer Interval 675.7 to 1089.5	379 titer Interval 290.2 to 493.9
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 14 (n=363, 359)	1028 titer Interval 866.9 to 1217.9	1059 titer Interval 896.6 to 1250.6
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 18C (n=366, 362)	2015 titer Interval 1675.4 to 2424.5	938 titer Interval 752.7 to 1170.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 19A (n=365, 362)	985 titer Interval 841.5 to 1153.9	429 titer Interval 358.0 to 513.2
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 19F (n=352, 357)	773 titer Interval 607.9 to 983.0	388 titer Interval 305.6 to 491.8
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 23F (n=366, 363)	456 titer Interval 363.7 to 570.6	180 titer Interval 143.1 to 226.1
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 12 Common Serotypes and Serotype 6A 1 Month After Vaccination 6A (n=360, 349)	2122 titer Interval 1790.9 to 2515.2	676 titer Interval 542.4 to 841.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 14 days after vaccination

Population: Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any local reaction. 'n'=number of participants with known values for specified local reaction for each group respectively. Participants may be represented in more than 1 category.

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).

Outcome measures

Outcome measures
Measure	13vPnC n=367 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=370 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Redness: Any (n=355, 363)	28.7 percentage of participants Interval 24.1 to 33.7	10.5 percentage of participants Interval 7.5 to 14.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Redness: Mild (n=352, 362)	22.2 percentage of participants Interval 17.9 to 26.9	7.7 percentage of participants Interval 5.2 to 11.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Redness: Moderate (n=353, 360)	17.3 percentage of participants Interval 13.5 to 21.6	3.9 percentage of participants Interval 2.1 to 6.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Redness: Severe (n=349, 359)	3.4 percentage of participants Interval 1.8 to 5.9	0.3 percentage of participants Interval 0.0 to 1.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Swelling: Any (n=353, 360)	21.5 percentage of participants Interval 17.4 to 26.2	6.7 percentage of participants Interval 4.3 to 9.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Swelling: Mild (n=351, 360)	16.5 percentage of participants Interval 12.8 to 20.8	5.0 percentage of participants Interval 3.0 to 7.8
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Swelling: Moderate (n=351, 359)	9.7 percentage of participants Interval 6.8 to 13.3	2.5 percentage of participants Interval 1.2 to 4.7
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Swelling: Severe (n=349, 359)	1.4 percentage of participants Interval 0.5 to 3.3	0.3 percentage of participants Interval 0.0 to 1.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Pain: Any (n=362, 368)	45.6 percentage of participants Interval 40.4 to 50.9	38.3 percentage of participants Interval 33.3 to 43.5
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Pain: Mild (n=362, 368)	45.3 percentage of participants Interval 40.1 to 50.6	37.5 percentage of participants Interval 32.5 to 42.7
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Pain: Moderate (n=349, 361)	2.9 percentage of participants Interval 1.4 to 5.2	5.5 percentage of participants Interval 3.4 to 8.4
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Pain: Severe (n=348, 359)	0.0 percentage of participants Interval 0.0 to 1.1	1.4 percentage of participants Interval 0.5 to 3.2
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Limitation of arm movement: Any (n=355, 362)	16.3 percentage of participants Interval 12.6 to 20.6	16.9 percentage of participants Interval 13.1 to 21.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Limitation of arm movement: Mild (n=355, 361)	15.5 percentage of participants Interval 11.9 to 19.7	15.8 percentage of participants Interval 12.2 to 20.0
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Limitation of arm movement: Moderate(n=348, 360)	1.1 percentage of participants Interval 0.3 to 2.9	3.6 percentage of participants Interval 1.9 to 6.1
Percentage of Participants Reporting Pre-specified Local Reactions Within 14 Days After Vaccination Limitation of arm movement: Severe (n=348, 359)	0.3 percentage of participants Interval 0.0 to 1.6	1.7 percentage of participants Interval 0.6 to 3.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 14 days after vaccination

Population: Safety population included all participants who received the study vaccine. 'N' (number of participants analyzed)=participants with known values for any systemic events. 'n'=number of participants with known values for specified systemic events for each group respectively. Participants may be represented in more than 1 category.

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.

Outcome measures

Outcome measures
Measure	13vPnC n=357 Participants 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=366 Participants 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Fever >=37.5 to <38.5 degrees C (n=348, 359)	2.6 percentage of participants Interval 1.2 to 4.9	2.8 percentage of participants Interval 1.3 to 5.1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Fever >=38.5 to <39 degrees C (n=348, 359)	0.3 percentage of participants Interval 0.0 to 1.6	0.3 percentage of participants Interval 0.0 to 1.5
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Fever >=39 to <=40 degrees C (n=348, 359)	0.0 percentage of participants Interval 0.0 to 1.1	0.6 percentage of participants Interval 0.1 to 2.0
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Fever >40 degrees C (n=348, 359)	0.9 percentage of participants Interval 0.2 to 2.5	0.0 percentage of participants Interval 0.0 to 1.0
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Fatigue (n=352, 362)	17.3 percentage of participants Interval 13.5 to 21.7	16.0 percentage of participants Interval 12.4 to 20.2
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Headache (n=351, 361)	9.4 percentage of participants Interval 6.6 to 12.9	11.6 percentage of participants Interval 8.5 to 15.4
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Chills (n=348, 359)	2.9 percentage of participants Interval 1.4 to 5.2	1.1 percentage of participants Interval 0.3 to 2.8
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Rash (n=350, 359)	8.9 percentage of participants Interval 6.1 to 12.3	3.6 percentage of participants Interval 1.9 to 6.1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Vomiting (n=348, 359)	1.1 percentage of participants Interval 0.3 to 2.9	0.6 percentage of participants Interval 0.1 to 2.0
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Decreased appetite (n=348, 360)	3.7 percentage of participants Interval 2.0 to 6.3	5.0 percentage of participants Interval 3.0 to 7.8
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination New muscle pain (n=354, 362)	18.4 percentage of participants Interval 14.5 to 22.8	17.4 percentage of participants Interval 13.6 to 21.7
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Aggravated muscle pain (n=350, 359)	4.0 percentage of participants Interval 2.2 to 6.6	3.9 percentage of participants Interval 2.1 to 6.5
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination New joint pain (n=350, 359)	7.7 percentage of participants Interval 5.1 to 11.0	7.0 percentage of participants Interval 4.6 to 10.1
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Aggravated joint pain (n=349, 359)	2.9 percentage of participants Interval 1.4 to 5.2	3.1 percentage of participants Interval 1.5 to 5.4
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Use of medication to treat fever (n=348, 360)	0.9 percentage of participants Interval 0.2 to 2.5	2.2 percentage of participants Interval 1.0 to 4.3
Percentage of Participants Reporting Pre-specified Systemic Events Within 14 Days After Vaccination Use of medication to treat pain (n=348, 360)	1.1 percentage of participants Interval 0.3 to 2.9	2.8 percentage of participants Interval 1.3 to 5.0

Adverse Events

13vPnC

Serious events: 1 serious events

Other events: 211 other events

Deaths: 0 deaths

23vPS

Serious events: 0 serious events

Other events: 166 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13vPnC n=382 participants at risk 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.	23vPS n=382 participants at risk 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.26% 1/382 • 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). SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).	0.00% 0/382 • 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). SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in the electronic diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER