Who is sponsoring NCT03571607?

NCT03571607 is sponsored by Pfizer.

What drugs are being tested in NCT03571607?

Interventions in NCT03571607: 13-valent pneumococcal conjugate vaccine.

What condition does NCT03571607 study?

NCT03571607 studies Pneumococcal Infections.

Is NCT03571607 still recruiting?

NCT03571607 is currently completed. Last updated 18 February 2020.

Are results published for NCT03571607?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-02-18 · How we verify

NCT03571607

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

Completed Phase 3 Results posted Last updated 18 February 2020

What this trial tests

Phase 3 trial testing 13-valent pneumococcal conjugate vaccine in Pneumococcal Infections in 206 participants. Completed in 16 November 2018.

Timeline

12 July 2018

Primary endpoint
16 November 2018

16 November 2018

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	206
Start date	12 July 2018
Primary completion	16 November 2018
Estimated completion	16 November 2018
Sites	8 locations across Japan

Drugs / interventions tested

13-valent pneumococcal conjugate vaccine (13-valent-pneumococcal-conjugate-vaccine) — full drug profile →

Conditions studied

Pneumococcal Infections — all drugs for Pneumococcal Infections →

Sponsor

Pfizer — full company profile →

Who can join

Adults 6 to 64, any sex, with Pneumococcal Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years Primary · Day 1 up to Day 7

Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.0 centimeter \[cm\]), moderate (greater than \[\>\] 2.0 to 7.0 cm) and severe (\>7.0 cm) for participants aged 6 to \<12 years, and as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm) for participants aged 12 to \<18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Redness: Any

Group	Value	95% CI
13vPnC: 6 to <18 Years	21.3	10.7 – 35.7

Redness: Mild

Group	Value	95% CI
13vPnC: 6 to <18 Years	10.6	3.5 – 23.1

Redness: Moderate

Group	Value	95% CI
13vPnC: 6 to <18 Years	10.6	3.5 – 23.1

Redness: Severe

Group	Value	95% CI
13vPnC: 6 to <18 Years	0.0	0.0 – 7.5

Swelling: Any

Group	Value	95% CI
13vPnC: 6 to <18 Years	34.0	20.9 – 49.3

Swelling: Mild

Group	Value	95% CI
13vPnC: 6 to <18 Years	14.9	6.2 – 28.3

Swelling: Moderate

Group	Value	95% CI
13vPnC: 6 to <18 Years	17.0	7.6 – 30.8

Swelling: Severe

Group	Value	95% CI
13vPnC: 6 to <18 Years	2.1	0.1 – 11.3

Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years Primary · Day 1 up to Day 14

Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and, severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Redness: Any

Group	Value	95% CI
13vPnC: 18 to <65 Years	7.4	3.6 – 13.2

Redness: Mild

Group	Value	95% CI
13vPnC: 18 to <65 Years	5.2	2.1 – 10.4

Redness: Moderate

Group	Value	95% CI
13vPnC: 18 to <65 Years	2.2	0.5 – 6.4

Redness: Severe

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.7

Swelling: Any

Group	Value	95% CI
13vPnC: 18 to <65 Years	12.5	7.5 – 19.3

Swelling: Mild

Group	Value	95% CI
13vPnC: 18 to <65 Years	5.1	2.1 – 10.3

Swelling: Moderate

Group	Value	95% CI
13vPnC: 18 to <65 Years	7.4	3.6 – 13.1

Swelling: Severe

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.7

Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years Primary · Day 1 up to Day 7

Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to \

Fever: 37.5 degree C to 38.4 degree C

Group	Value	95% CI
13vPnC: 6 to <18 Years	12.5	4.7 – 25.2

Fever: 38.5 degree C to 38.9 degree C

Group	Value	95% CI
13vPnC: 6 to <18 Years	2.1	0.1 – 11.1

Fever: 39.0 degree C to 40.0 degree C

Group	Value	95% CI
13vPnC: 6 to <18 Years	0.0	0.0 – 7.4

Fever: >40.0 degree C

Group	Value	95% CI
13vPnC: 6 to <18 Years	0.0	0.0 – 7.4

Fatigue: Any

Group	Value	95% CI
13vPnC: 6 to <18 Years	37.5	24.0 – 52.6

Fatigue: Mild

Group	Value	95% CI
13vPnC: 6 to <18 Years	25.0	13.6 – 39.6

Fatigue: Moderate

Group	Value	95% CI
13vPnC: 6 to <18 Years	10.4	3.5 – 22.7

Fatigue: Severe

Group	Value	95% CI
13vPnC: 6 to <18 Years	2.1	0.1 – 11.1

Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years Primary · Day 1 up to Day 14

Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 loose stools in 24 hours). Heada

Fever: 37.5 degree C to 38.4 degree C

Group	Value	95% CI
13vPnC: 18 to <65 Years	6.0	2.6 – 11.4

Fever: 38.5 degree C to 38.9 degree C

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.7

Fever: 39.0 degree C to 40.0 degree C

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.7

Fever: >40.0 degree C

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.7

Fatigue: Any

Group	Value	95% CI
13vPnC: 18 to <65 Years	33.1	25.4 – 41.5

Fatigue: Mild

Group	Value	95% CI
13vPnC: 18 to <65 Years	25.4	18.4 – 33.3

Fatigue: Moderate

Group	Value	95% CI
13vPnC: 18 to <65 Years	7.7	3.9 – 13.4

Fatigue: Severe

Group	Value	95% CI
13vPnC: 18 to <65 Years	0.0	0.0 – 2.6

Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Primary · signing of informed consent form (Day 1) up to Day 43

An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect.

AEs

Group	Value	95% CI
13vPnC: All Participants	16

SAEs

Group	Value	95% CI
13vPnC: All Participants	0

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination Secondary · Pre-vaccination and 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 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). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as recipr

Pre-vaccination; Serotype 1

Group	Value	95% CI
13vPnC: All Participants	10	9.2 – 10.2

1 month after vaccination; Serotype 1

Group	Value	95% CI
13vPnC: All Participants	152	119.2 – 193.8

Pre-vaccination; Serotype 3

Group	Value	95% CI
13vPnC: All Participants	11	9.8 – 13.1

1 month after vaccination; Serotype 3

Group	Value	95% CI
13vPnC: All Participants	63	52.6 – 75.8

Pre-vaccination; Serotype 4

Group	Value	95% CI
13vPnC: All Participants	18	14.5 – 22.1

1 month after vaccination; Serotype 4

Group	Value	95% CI
13vPnC: All Participants	1257	896.0 – 1763.8

Pre-vaccination; Serotype 5

Group	Value	95% CI
13vPnC: All Participants	16	15.3 – 17.5

1 month after vaccination; Serotype 5

Group	Value	95% CI
13vPnC: All Participants	185	143.9 – 237.5

Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination Secondary · Pre-vaccination to 1 month after vaccination

OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.

Serotype 1

Group	Value	95% CI
13vPnC: All Participants	15.6	12.33 – 19.82

Serotype 3

Group	Value	95% CI
13vPnC: All Participants	5.5	4.59 – 6.54

Serotype 4

Group	Value	95% CI
13vPnC: All Participants	61.7	42.80 – 88.99

Serotype 5

Group	Value	95% CI
13vPnC: All Participants	11.2	8.69 – 14.34

Serotype 6A

Group	Value	95% CI
13vPnC: All Participants	34.7	24.39 – 49.44

Serotype 6B

Group	Value	95% CI
13vPnC: All Participants	21.9	15.71 – 30.51

Serotype 7F

Group	Value	95% CI
13vPnC: All Participants	12.1	9.84 – 14.76

Serotype 9V

Group	Value	95% CI
13vPnC: All Participants	6.8	5.36 – 8.62

Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination Secondary · Pre-vaccination and 1 month after vaccination

Pneumococcal IgG antibody 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 direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution.

Pre-vaccination; Serotype 1

Group	Value	95% CI
13vPnC: All Participants	0.132	0.109 – 0.161

1 month after vaccination; Serotype 1

Group	Value	95% CI
13vPnC: All Participants	4.427	3.423 – 5.726

Pre-vaccination; Serotype 3

Group	Value	95% CI
13vPnC: All Participants	0.115	0.094 – 0.141

1 month after vaccination; Serotype 3

Group	Value	95% CI
13vPnC: All Participants	0.531	0.437 – 0.646

Pre-vaccination; Serotype 4

Group	Value	95% CI
13vPnC: All Participants	0.055	0.045 – 0.068

1 month after vaccination; Serotype 4

Group	Value	95% CI
13vPnC: All Participants	1.826	1.387 – 2.404

Pre-vaccination; Serotype 5

Group	Value	95% CI
13vPnC: All Participants	0.058	0.046 – 0.075

1 month after vaccination; Serotype 5

Group	Value	95% CI
13vPnC: All Participants	2.779	1.972 – 3.915

GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination Secondary · Pre- vaccination to 1 month after vaccination

IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination.

Serotype 1

Group	Value	95% CI
13vPnC: All Participants	33.445	26.374 – 42.413

Serotype 3

Group	Value	95% CI
13vPnC: All Participants	4.605	3.839 – 5.524

Serotype 4

Group	Value	95% CI
13vPnC: All Participants	32.960	25.331 – 42.886

Serotype 5

Group	Value	95% CI
13vPnC: All Participants	47.565	36.867 – 61.368

Serotype 6A

Group	Value	95% CI
13vPnC: All Participants	23.587	18.010 – 30.890

Serotype 6B

Group	Value	95% CI
13vPnC: All Participants	22.421	17.045 – 29.493

Serotype 7F

Group	Value	95% CI
13vPnC: All Participants	39.843	31.473 – 50.438

Serotype 9V

Group	Value	95% CI
13vPnC: All Participants	22.232	17.426 – 28.362

Adverse events — posted to ClinicalTrials.gov

Time frame: signing of informed consent form (Day 1) up to Day 43. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

13vPnC: 6 to <18 Years

Serious: 0/53 (0%)

Deaths: 0/53

13vPnC: 18 to <65 Years

Serious: 0/153 (0%)

Deaths: 0/153

13vPnC: All Participants

Serious: 0/206 (0%)

Deaths: 0/206

Other adverse events (32 terms — click to expand)

Reaction	System	13vPnC: 6 to <18 Years	13vPnC: 18 to <65 Years	13vPnC: All Participants
Pain at the injection site	General disorders	—	—	—
Fatigue	General disorders	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Injection site swelling	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Redness	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Injection site pain	General disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Conjunctivitis	Infections and infestations	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Herpes zoster	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Wrist fracture	Injury, poisoning and procedural complications	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Middle insomnia	Psychiatric disorders	—	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—	—
Hyperventilation	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Rash papular	Skin and subcutaneous tissue disorders	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—

Data from ClinicalTrials.gov NCT03571607 adverse events section.

Sponsor's own description

This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and
Yamazaki Y, Ikeda M, Imada T, Furuno K, et al · · 2021 · cited 2× · PMID 34563397 · DOI 10.1016/j.vaccine.2021.08.106

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03571607 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03571607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing