Immunogenicity, VaccineNCT05372575

A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

A study testing PCV13 PAC study in people with Immunogenicity, Vaccine, run by Pfizer at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset. Read more about this study

Who is it for?: Ages 5 to 60 months
Conditions the study is for: Immunogenicity, Vaccine
What is being tested?: PCV13 PAC study
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteChina
Study dates: 15 Aug 2019to 14 Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 60 months
All sexes
No healthy volunteers
Child

Who may be able to join

Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
A diagnosis of clinical pneumonia per SCH standard of care.
5 months to ≤60 months of age at the time of consent.
Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation.

Who cannot join

Infant or child who is a family member of:
Investigator site staff members directly involved in the conduct of the study;
Site staff members otherwise supervised by the investigator;
Pfizer employees directly involved in the conduct of the study.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Blood draw is counter indicated.

Show all 10Show fewer

Previous participation in this study within 30 days.
Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China.
Received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw.
Hospital acquired pneumonia (ie, onset >48 hours after hospitalization).

Trial locations and contacts

1 site in 1 country.

China1 site

Children's Hospital of Soochow University
Suzhou, Jiangsu, 215003

Other trials in China

About this study

Official title: A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS

Conditions: Immunogenicity, Vaccine
Being tested: PCV13 PAC study
Keywords: Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCV13 PAC studyBiological
To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.

Study groups in NCT05372575
Study group	Role	What they receive
PCV13 group and non PCV13 group	Other	This study plan to recruit those young patients who have or not have got PCV13 vaccine before study start Receives: Biological: PCV13 PAC study

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample.
Measured: Day 1
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution.
Measured: Day 1
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier).
Measured: Day 1
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 201914 Dec 2021

First posted12 May 2022
Study start15 Aug 2019
Primary completion14 Dec 2021
Study completion14 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immunogenicity, VaccineStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05372575
Sponsor's protocol ID: B1851196
Other IDs: 2022-000845-34
Status last verified: Dec 2022
First submitted: 29 Mar 2022
Last updated: 3 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
RecruitingPhase 3
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Healthy
RecruitingPhase 4
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
SARS-CoV-2
Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
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Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
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All Immunogenicity, Vaccine trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
ClinicalTrials.gov ID: NCT05372575
Acronym / sponsor ID: B1851196
Conditions: Immunogenicity, Vaccine
Keywords: Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 15 Aug 2019 (actual)
Primary completion: 14 Dec 2021 (actual)
Study completion: 14 Dec 2021 (actual)
First posted: 12 May 2022 (actual)
Results: Posted 3 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PCV13 group and non PCV13 group	Other	Biological: PCV13 PAC studyThis study plan to recruit those young patients who have or not have got PCV13 vaccine before study start

Who may qualify

Ages: 5 to 60 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study.
Subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures.
A diagnosis of clinical pneumonia per SCH standard of care.
5 months to ≤60 months of age at the time of consent.
Vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation.

Key exclusion criteria (10 listed)

Infant or child who is a family member of:
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Blood draw is counter indicated.
Previous participation in this study within 30 days.
Previous vaccination with licensed or investigational pneumococcal vaccine. This excludes previous vaccination with 13vPnC as per the approved recommendations in China.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCV13 PAC studyTo test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.	Biological	PCV13 group and non PCV13 group

Primary outcome

Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort
Time frame: Day 1
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by enzyme-linked immunosorbent assay (ELISA) for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample.
Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort
Time frame: Day 1
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. Titer was expressed as reciprocal of the highest serum dilution.
GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis
Time frame: Day 1
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum concentrations of anticapsular IgG were determined by ELISA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in all participants with a collected blood sample. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier).
GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis
Time frame: Day 1
Approximately 5 mL of blood sample was collected within 24 hours of enrollment. Blood must have been drawn from peripheral veins (eg, arm, foot, or scalp veins). Serum levels of MOPA for each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all 13vPnC cohort participants with adequate blood volume. In the Non-13vPnC cohort, a sample of participants with adequate blood volume was selected, to be equal to the number of the 13vPnC Cohort included for MOPA testing. For each cohort, participants were assigned to 2 subgroups: Participant in whom a 13vPnC VT strain had been isolated from the respiratory tract, and participant from whom a 13vPnC VT strain had not been isolated from the respiratory tract (VT carrier versus without VT carrier). Titer was expressed as reciprocal of the highest serum dilution.

Results and safety

Results posted to the registry on 3 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
13vPnC Cohort	101	94
Non-13vPnC Cohort	199	183

Primary outcome: Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort

Time frame: Day 1. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (µg/mL)

Measure	13vPnC Cohort n = 92	Non-13vPnC Cohort n = 184
Serotype: 1	1.55 (1.17 to 2.06)	0.12 (0.09 to 0.15)
Serotype: 3	0.42 (0.32 to 0.54)	0.07 (0.06 to 0.08)
Serotype: 4	1.36 (1.00 to 1.84)	0.08 (0.06 to 0.10)
Serotype: 5	1.74 (1.41 to 2.15)	0.72 (0.63 to 0.82)
Serotype: 6A	2.42 (1.85 to 3.15)	0.38 (0.33 to 0.44)
Serotype: 6B	2.47 (1.90 to 3.22)	0.37 (0.32 to 0.43)
Serotype: 7F	1.81 (1.41 to 2.32)	0.19 (0.16 to 0.23)
Serotype: 9V	1.18 (0.96 to 1.46)	0.30 (0.26 to 0.36)

13vPnC Cohort vs Non-13vPnC Cohort: Geometric Mean Ratio (GMR): 13.16 (95% CI 8.99 to 19.28)
13vPnC Cohort vs Non-13vPnC Cohort: GMR: 5.88 (95% CI 4.32 to 8.01)
13vPnC Cohort vs Non-13vPnC Cohort: GMR: 17.98 (95% CI 12.07 to 26.78)

Population analysed: Analysis population for this outcome measure (OM) included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.

Primary outcome: Geometric Mean Titers (GMTs) of Pneumococcal Multiplex Opsonophagocytic Activity (MOPA) by Cohort

Time frame: Day 1. Number (95% Confidence Interval). Unit: Titers

Measure	13vPnC Cohort n = 92	Non-13vPnC Cohort n = 184
Serotype: 1	70.9 (40.8 to 123.3)	14.8 (9.2 to 24.0)
Serotype: 3	272.8 (173.9 to 428.0)	30.1 (18.7 to 48.4)
Serotype: 4	1148.4 (755.0 to 1746.6)	79.9 (38.6 to 165.3)
Serotype: 5	326.5 (197.8 to 538.8)	18.1 (10.8 to 30.2)
Serotype: 6A	1825.9 (1077.4 to 3094.4)	53.9 (27.0 to 107.4)
Serotype: 6B	844.8 (489.7 to 1457.4)	60.1 (31.9 to 113.4)
Serotype: 7F	3791.4 (2495.7 to 5759.6)	223.2 (115.8 to 430.2)
Serotype: 9V	919.7 (559.9 to 1510.6)	47.6 (27.2 to 83.3)

13vPnC Cohort vs Non-13vPnC Cohort: Geometric Mean Ratio (GMR): 4.78 (95% CI 2.32 to 9.86)
13vPnC Cohort vs Non-13vPnC Cohort: GMR: 9.06 (95% CI 4.72 to 17.39)
13vPnC Cohort vs Non-13vPnC Cohort: GMR: 14.37 (95% CI 6.25 to 33.05)

Population analysed: Analysis population for this OM included all participants who signed the informed consent document, met all inclusion/exclusion criteria, and had at least 1 immunogenicity assay value available for analysis. Overall number of participants analyzed indicates the number of participants in this analysis population. Number Analyzed in each row indicates the number of participants with valid and determinate assay results for the specified serotype.

Primary outcome: GMCs of Pneumococcal IgG by Cohort and Vaccine Type (VT) Carriage Status - Subgroup Analysis

Time frame: Day 1. Geometric mean (95% Confidence Interval). Unit: microgram per milliliter (µg/mL)

Measure	13vPnC Cohort: VT+ Subgroup n = 7	13vPnC Cohort: VT- or Sp- Subgroup n = 79	Non-13vPnC Cohort: VT+ Subgroup n = 20	Non-13vPnC Cohort: VT- or Sp- Subgroup n = 140
Serotype: 1	0.81 (0.28 to 2.33)	1.69 (1.23 to 2.31)	0.08 (0.04 to 0.18)	0.12 (0.09 to 0.16)
Serotype: 3	0.32 (0.10 to 1.04)	0.44 (0.33 to 0.58)	0.05 (0.03 to 0.09)	0.07 (0.06 to 0.09)
Serotype: 4	0.97 (0.26 to 3.64)	1.43 (1.02 to 2.00)	0.05 (0.02 to 0.11)	0.07 (0.05 to 0.09)
Serotype: 5	1.45 (0.51 to 4.15)	1.77 (1.41 to 2.24)	0.58 (0.40 to 0.83)	0.72 (0.61 to 0.85)
Serotype: 6A	1.78 (0.73 to 4.32)	2.59 (1.93 to 3.48)	0.34 (0.22 to 0.51)	0.36 (0.31 to 0.43)
Serotype: 6B	1.94 (0.78 to 4.81)	2.60 (1.93 to 3.50)	0.51 (0.31 to 0.84)	0.33 (0.28 to 0.40)
Serotype: 7F	0.83 (0.36 to 1.92)	1.97 (1.50 to 2.59)	0.14 (0.07 to 0.29)	0.19 (0.15 to 0.23)
Serotype: 9V	0.97 (0.37 to 2.53)	1.21 (0.96 to 1.54)	0.22 (0.10 to 0.46)	0.30 (0.25 to 0.36)

13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: Geometric Mean Ratio (GMR): 0.48 (95% CI 0.16 to 1.42)
13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: GMR: 0.74 (95% CI 0.27 to 1.98)
13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: GMR: 0.68 (95% CI 0.21 to 2.19)

Primary outcome: GMTs of Pneumococcal MOPA by Cohort and VT Carriage Status - Subgroup Analysis

Time frame: Day 1. Number (95% Confidence Interval). Unit: Titers

Measure	13vPnC Cohort: VT+ Subgroup n = 7	13vPnC Cohort: VT- or Sp- Subgroup n = 79	Non-13vPnC Cohort: VT+ Subgroup n = 20	Non-13vPnC Cohort: VT- or Sp- Subgroup n = 140
Serotype: 1	35.0 (2.2 to 547.7)	71.1 (38.4 to 131.4)	11.1 (4.1 to 30.5)	14.6 (8.4 to 25.4)
Serotype: 3	146.6 (35.6 to 602.7)	273.7 (163.5 to 458.2)	29.2 (14.0 to 61.0)	28.6 (16.3 to 50.1)
Serotype: 4	522.0 (165.0 to 1651.2)	1154.4 (726.1 to 1835.4)	38.1 (6.7 to 216.9)	86.1 (37.4 to 198.3)
Serotype: 5	539.5 (41.4 to 7035.5)	302.7 (173.2 to 529.0)	11.1 (3.6 to 34.7)	17.6 (9.9 to 31.4)
Serotype: 6A	482.4 (31.8 to 7306.4)	2110.3 (1176.4 to 3785.6)	46.1 (5.8 to 366.1)	52.5 (23.7 to 116.2)
Serotype: 6B	69.4 (1.4 to 3480.8)	1099.1 (639.5 to 1889.0)	102.7 (14.2 to 742.0)	53.9 (26.4 to 110.3)
Serotype: 7F	4661.3 (2222.1 to 9777.9)	3837.7 (2367.8 to 6220.2)	442.5 (87.9 to 2228.3)	180.8 (84.0 to 389.4)
Serotype: 9V	215.9 (6.7 to 6985.7)	1074.9 (637.7 to 1811.9)	65.0 (13.3 to 318.0)	45.3 (23.7 to 86.6)

13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: GMR: 0.49 (95% CI 0.06 to 3.91)
13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: GMR: 0.54 (95% CI 0.10 to 2.92)
13vPnC Cohort: VT+ Subgroup vs 13vPnC Cohort: VT- or Sp- Subgroup: GMR: 0.45 (95% CI 0.10 to 2.07)

Adverse events

Time frame: From the time of the blood draw or aspirate collection through and including 12 hours on Day 1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
13vPnC Cohort	0 of 101 (0%)	0 of 101 (0%)	0 of 101
Non-13vPnC Cohort	0 of 199 (0%)	0 of 199 (0%)	0 of 199

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PCV13 PAC study in people with Immunogenicity, Vaccine, run by Pfizer at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentrations (GMCs) of Pneumococcal Immunoglobulin G (IgG) by Cohort (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05372575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.