ClinicalTrials.gg
Sign In
TerminatedNCT03276754Updated Aug 19, 2024Results posted

Immunization To Prevent Acute COPD Exacerbations

An observational study in Pneumococcal Infections and COPD, sponsored by Pfizer. Terminated at 11 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Pfizer · Observational

Why this study was terminated
The study was terminated prematurely due to the inability to recruit the planned number of subjects and the interim analysis indicated that the number of included patients did not allow draw any valid conclusion about the main objective of the study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
530
Ages
18 Years and older
Sex
All
01

Study summary

Prospective multicenter observational study, to evaluate the impact of routine clinical practice vaccination with PCV13 on the reduction of the risk of moderate/severe COPD exacerbations

Read the detailed description

Patients with chronic obstructive pulmonary disease (COPD) have been demonstrated to have an increased risk of pneumococcal disease. Pneumonia is frequent among patients hospitalized for COPD exacerbations and is associated with increased health care utilization and higher mortality. Up to 50%-70% of exacerbations can be attributed to respiratory infections by viruses or bacteria, even more in the most severe patients. They are often associated with the colonization of airways by multiple bacteria or viruses of low virulence that in normal conditions are parts of the normal flora of the upper airway. Current recommendations for immunization of patients with COPD include vaccination against influenza and Streptococcus pneumoniae. The aim of this study is to evaluate the potential benefits of immunization of COPD patients with PCV13 and/or against influenza in terms of clinical benefits and quality of life.

02

Conditions studied

  • Pneumococcal Infections
  • COPD

Keywords

  • Pneumococcal infections
  • COPD exacerbations
03

In context

Pneumococcal Infections

286 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.

This study's enrollment of 530 is below the median of 659 across 49 observational studies indexed under Pneumococcal Infections.

Browse Pneumococcal Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Subjects ≥18 years diagnosed with COPD, followed up at the Pulmonology Department of the partipant centres

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient ≥18 years diagnosed with COPD (any stage, the subgroups for the analysis would be based on COPD severity grade)
  2. Ability to understand and complete the required QoL questionnaires
  3. At least 2 years of clinical history available that includes records of previous moderate/severe exacerbations, influenza and pneumococcal vaccination history comorbidities and previous treatments.
  4. Spirometry data (maximum 6 months old, or if not available at enrollment, to be performed as per normal clinical practice at visit 1 +/- one month)

Exclusion criteria

Exclusion criteria:

  1. Impossibility to perform prospective follow up
  2. Present any immunocompromising condition
  3. Present any other respiratory diseases as co-morbidity (subjects with overlap syndromes COPD-asthma will be excluded. Mixed phenotype defined as: symptoms of increased variability of airflow and incompletely reversible airflow obstruction)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
530 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population

    COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.

    Time frame: Baseline and Month 24

  2. Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population

    Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. COPD severity was graded as per GOLD criteria. Grade 1 mild/unknown: (FEV1 \>= 80 %, FEV1/ FVC \< 0.7 or no spirometry data). Grade 2: Moderate: (50% \<= FEV1\< 80%, FEV1/FVC \< 0.7), Grade 3: Severe (30% \<=FEV1 \< 50%, FEV1/FVC \< 0.7), Grade 4: Very severe (FEV1\< 30% or FEV1\< 50% plus respiratory failure, FEV1/FVC \< 0.7). Adjusted rate of exacerbation was calculated as (total no. of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in adjusted rate of moderate/severe exacerbations by COPD severity (Grade 1 and Grade \>1) at Month 24 is reported.

    Time frame: Baseline and Month 24

Secondary outcomes

  1. Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination

    Evaluate the impact of influenza and PCV13 vaccination on the reduction of COPD exacerbations. Adjusted rate of exacerbation was calculated as (total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in rate of moderate/severe exacerbations with and without history of influenza vaccination is presented in this outcome measure.

    Time frame: Month 24

  2. Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population

    To evaluate the impact of vaccination with PCV13 on patients quality of life SGRQ form was used. It is a self-administered questionnaire developed to measure health status (quality of life) in participants with chronic airflow limitation. The SGRQ consisted of 50 items, where 10 of them were multiple choice and 40 were true or false. Scores were calculated for three domains: Symptoms (eight items; including cough, sputum production, dyspnea or shortness of breath or breathlessness and wheezing, as well as duration, frequency and severity); Activity (16 true or false questions; refers to activities that are limited due to dyspnea);Impacts (26 items; referred to other situations or aspects related to social or psychological functioning affected by the respiratory problems that may alter the participants lifestyle). The total score and scores for each domain ranged from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).

    Time frame: Baseline, Month 12 and 24

  3. Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population

    To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease.

    Time frame: Baseline, Month 12 and 24

  4. Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population

    To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.

    Time frame: Baseline, Month 24

  5. Percentage of Participants With COPD Vaccinated With PCV13

    Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.

    Time frame: Up to Month 24

Other outcomes

  1. Mean Cost Saving Per COPD Participant With PCV13

    Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure.

    Time frame: Up to Month 24

07

Results

Posted Aug 19, 2024
Limitations and caveats
Several limitations related to the study, such as lack of data about relevant confounding factors, and a lower than expected sample size, which makes impossible the adjustment of analyses by relevant confounding factors such as age, presence and number of comorbidities, severity of the disease, etc, make difficult to discard that the changes in the exacerbation rates are due to other causes.

Participant flow

Participants diagnosed with Chronic Obstructive Pulmonary Disease (COPD) across 11 hospitals in Spain were followed up during their routine follow-up visits in this prospective observational study. Participants were prescribed therapies in line with routine clinical practice.

Participant flow — Overall Study
MilestoneParticipants With COPD
Started530
Without pneumococcal vaccination126
With pneumococcal vaccination404
13-valent pneumococcal conjugate vaccine (pcv13) population114
Completed421
Not completed109
Withdrew: Withdrawal of informed consent4
Withdrew: Presence of any immunosuppressive condition8
Withdrew: Lost to follow-up27
Withdrew: No data reported at month 2431
Withdrew: Death39

Outcome measures

PrimaryChange in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population

COPD exacerbations were defined as a complex of two or more respiratory symptoms (worsening dyspnea, cough, sputum production, chest tightness, or wheezing) related to the underlying COPD, with duration of 3 days or more, that required a change in treatment. Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. Adjusted rate of exacerbation was calculated as (Total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months.

Time frame:
Baseline and Month 24
Reported as:
Mean · Exacerbation per participant in 24 month
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population
Exacerbation per participant in 24 monthParticipants With COPD
Change in Adjusted Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV 13 Population-1.1 ± 2.5
PrimaryChange in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population

Moderate exacerbations were those that required antibiotics and/or systemic corticosteroids without hospitalization. Severe exacerbations were those that lead to hospitalization. COPD severity was graded as per GOLD criteria. Grade 1 mild/unknown: (FEV1 \>= 80 %, FEV1/ FVC \< 0.7 or no spirometry data). Grade 2: Moderate: (50% \<= FEV1\< 80%, FEV1/FVC \< 0.7), Grade 3: Severe (30% \<=FEV1 \< 50%, FEV1/FVC \< 0.7), Grade 4: Very severe (FEV1\< 30% or FEV1\< 50% plus respiratory failure, FEV1/FVC \< 0.7). Adjusted rate of exacerbation was calculated as (total no. of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in adjusted rate of moderate/severe exacerbations by COPD severity (Grade 1 and Grade \>1) at Month 24 is reported.

Time frame:
Baseline and Month 24
Reported as:
Mean · Exacerbation per participant in 24 month
Change in Adjusted Rate of Moderate/Severe Exacerbations by COPD Severity at Month 24 in PCV13 Population
Exacerbation per participant in 24 monthParticipants With COPD
Grade 1: Mild/unknown-1.5 ± 0.9
Grade >1: Moderate to Very Severe-1.1 ± 2.6
SecondaryChange in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination

Evaluate the impact of influenza and PCV13 vaccination on the reduction of COPD exacerbations. Adjusted rate of exacerbation was calculated as (total number of moderate or severe exacerbations) divided by participant follow-up time in months\*24 months. Change in rate of moderate/severe exacerbations with and without history of influenza vaccination is presented in this outcome measure.

Time frame:
Month 24
Reported as:
Mean · Exacerbation per participant in 24 month
Change in Rate of Moderate/Severe COPD Exacerbations at Month 24 in PCV13 Population by History of Influenza Vaccination
Exacerbation per participant in 24 monthParticipants With COPD
Influenza vaccination: No-0.7 ± 2.2
Influenza vaccination: Yes-1.2 ± 2.6
SecondaryChange From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population

To evaluate the impact of vaccination with PCV13 on patients quality of life SGRQ form was used. It is a self-administered questionnaire developed to measure health status (quality of life) in participants with chronic airflow limitation. The SGRQ consisted of 50 items, where 10 of them were multiple choice and 40 were true or false. Scores were calculated for three domains: Symptoms (eight items; including cough, sputum production, dyspnea or shortness of breath or breathlessness and wheezing, as well as duration, frequency and severity); Activity (16 true or false questions; refers to activities that are limited due to dyspnea);Impacts (26 items; referred to other situations or aspects related to social or psychological functioning affected by the respiratory problems that may alter the participants lifestyle). The total score and scores for each domain ranged from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status).

Time frame:
Baseline, Month 12 and 24
Reported as:
Mean · Units on a scale
Change From Baseline in Saint George Respiratory Questionnaire (SGRQ) Score at Month 12 and 24 in PCV13 Population
Units on a scaleParticipants With COPD
Baseline: QOL45.7 ± 15.4
Change at Month 12: QOL-5.6 ± 17.4
Change at Month 24: QOL-6.0 ± 13.8
Baseline: Symptoms47.4 ± 18.9
Change at Month 12: Symptoms-9.0 ± 26.2
Change at Month 24: Symptoms-16.3 ± 23.4
Baseline: Activity56.3 ± 21.2
Change at Month 12: Activity-4.6 ± 19.9
Change at Month 24: Activity-4.2 ± 17.3
Baseline: Impacts39.7 ± 15.4
Change at Month 12: Impacts-5.6 ± 19.1
Change at Month 24: Impacts-6.5 ± 15.5
SecondaryChange From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population

To evaluate the impact of vaccination with PCV13 on patients quality of life ,CAT questionnaire is used. It is used to measure the impact COPD on the participant's wellbeing and daily life and severity of symptoms. The CAT has 8 questions, with score ranging from 0 to 5 for each question, where 0 = no impairment and 5=severe impairment. Total score was calculated as the sum of scores of individual questions and ranged from 0 to 40 with higher scores indicating more severe disease.

Time frame:
Baseline, Month 12 and 24
Reported as:
Mean · Units on a scale
Change From Baseline in COPD Assessment Test (CAT) Score at Month 12 and 24 in PCV13 Population
Units on a scaleParticipants With COPD
Baseline15.5 ± 7.5
Change at Month 12-1.7 ± 6.3
Change at Month 24-1.8 ± 6.1
SecondaryChange From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population

To evaluate the impact of vaccination with PCV13 on the decrease of FEV1 was evaluated. FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.

Time frame:
Baseline, Month 24
Reported as:
Mean · Percentage
Change From Baseline in Forced Expiratory Volume (FEV1) at Month 24 in PCV13 Population
PercentageParticipants With COPD
Baseline51.9 ± 19.0
Change at Month 24-1.7 ± 10.9
SecondaryPercentage of Participants With COPD Vaccinated With PCV13

Percentage of evaluable study participants vaccinated with PCV13 prior or after inclusion in the study.

Time frame:
Up to Month 24
Reported as:
Number · Percentage of Participants
Percentage of Participants With COPD Vaccinated With PCV13
Percentage of ParticipantsParticipants With COPD
Percentage of Participants With COPD Vaccinated With PCV1346.8
Other pre-specifiedMean Cost Saving Per COPD Participant With PCV13

Overall cost of hospitalization and/or treatment of exacerbation episode based on days of hospitalization or Intensive care unit and treatment received were planned to be analyzed in this outcome measure.

Time frame:
Up to Month 24
Reported as:
Number · Euro per participant per year
Mean Cost Saving Per COPD Participant With PCV13
Euro per participant per yearParticipants With COPD
Mean Cost Saving Per COPD Participant With PCV13NA

Adverse events

Collected over Up to 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Participants With COPD39/530 (7.4%)78/530 (14.7%)10/530 (1.9%)
Most frequent serious events
Showing 10 of 49
Most frequent serious events
EventParticipants With COPD
PneumoniaInfections and infestations17/530
COVID-19 pneumoniaInfections and infestations10/530
DeathGeneral disorders9/530
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders7/530
Cardio-respiratory arrestCardiac disorders6/530
Cardiac failureCardiac disorders4/530
COVID-19Infections and infestations3/530
Acute myocardial infarctionCardiac disorders3/530
PneumothoraxRespiratory, thoracic and mediastinal disorders3/530
Abdominal sepsisInfections and infestations1/530
Most frequent other events
Most frequent other events
EventParticipants With COPD
Chest painGeneral disorders1/530
Local reactionGeneral disorders1/530
Vaccination site reactionGeneral disorders1/530
COVID-19Infections and infestations1/530
COVID-19 pneumoniaInfections and infestations1/530
TachyarrhythmiaCardiac disorders1/530
ImmunosuppressionImmune system disorders1/530
Procedural pneumothoraxInjury, poisoning and procedural complications1/530
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders1/530
Pulmonary resectionSurgical and medical procedures1/530

Baseline characteristics

Analysis population included all evaluable participants whose data were included and prospectively observed in the study.

Age, Continuous
Age, Continuous(Years)Participants With COPD
Overall70.2 ± 7.9
Without pneumococcal vaccination68.2 ± 8.4
With pneumococcal vaccination70.8 ± 7.7
PCV13 Population69.2 ± 7.9
Sex: Female, Male
Sex: Female, Male(Participants)Participants With COPD
Overall — Female133
Overall — Male397
Without pneumococcal vaccination — Female42
Without pneumococcal vaccination — Male84
With pneumococcal vaccination — Female91
With pneumococcal vaccination — Male313
PCV13 Population — Female26
PCV13 Population — Male88
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Participants With COPD
Weight
Weight(Kilogram)Participants With COPD
Overall75.0 ± 16.1
Without pneumococcal vaccination74.1 ± 18.9
With pneumococcal vaccination75.2 ± 15.1
PCV13 Population75.2 ± 14.1
Height
Height(Centimeters)Participants With COPD
Overall164.7 ± 8.4
Without pneumococcal vaccination163.8 ± 9.2
With pneumococcal vaccination164.9 ± 8.1
PCV13 Population164.9 ± 7.9
Body Mass Index
Body Mass Index(Kilograms per meter square)Participants With COPD
Overall27.5 ± 5.1
Without pneumococcal vaccination27.4 ± 5.8
With pneumococcal vaccination27.6 ± 4.8
PCV13 Population27.7 ± 4.8
Waist circumference
Waist circumference(Centimeters)Participants With COPD
Overall98.4 ± 16.4
Without pneumococcal vaccination99.1 ± 17.5
With pneumococcal vaccination98.2 ± 16.1
PCV13 Population100.1 ± 17.0
Relevant Medical History
Relevant Medical History(Participants)Participants With COPD
Overall: Medical History- No39
Overall: Medical History- Yes491
Overall: Medical History- Yes (Arterial hypertension)279
Overall: Medical History- Yes (Dyslipidemia)241
Overall: Medical History- Yes (Diabetes mellitus)112
Overall: Medical History- Yes (History of neoplasm)78
Overall: Medical History- Yes (Ischemic heart disease)53
Overall: Medical History- Yes (Cardiac failure)37
Overall: Medical History- Yes (Pneumonias in the last year)36
Overall: Medical History- Yes (Chronic renal failure)27
Overall: Medical History- Yes (Metabolic syndrome)2
Without Pneumococcal Vaccination: No12
Without Pneumococcal Vaccination: Yes114
Without Pneumococcal Vaccination: Yes (Arterial hypertension)60
Without Pneumococcal Vaccination: Yes (Dyslipidemia)53
Without Pneumococcal Vaccination: Yes (Diabetes mellitus)27
Without Pneumococcal Vaccination: Yes (History of neoplasm)10
Without Pneumococcal Vaccination: Yes (Ischemic heart disease)6
Without Pneumococcal Vaccination: Yes (Cardiac failure)11
Without Pneumococcal Vaccination: Yes (Pneumonias in the last year)9
Without Pneumococcal Vaccination: Yes (Chronic renal failure)1
Without Pneumococcal Vaccination: Yes (Metabolic syndrome)0
With Pneumococcal Vaccination: No27
With Pneumococcal Vaccination: Yes377
With Pneumococcal Vaccination: Yes (Arterial hypertension)219
With Pneumococcal Vaccination: Yes (Dyslipidemia)188
With Pneumococcal Vaccination: Yes (Diabetes mellitus)85
With Pneumococcal Vaccination: Yes (History of neoplasm)68
With Pneumococcal Vaccination: Yes (Ischemic heart disease)47
With Pneumococcal Vaccination: Yes (Cardiac failure)26
With Pneumococcal Vaccination: Yes (Pneumonias in the last year)27
With Pneumococcal Vaccination: (Chronic renal failure)26
With Pneumococcal Vaccination: (Metabolic syndrome)2
PCV 13 Population: No13
PCV 13 Population: Yes101
PCV 13 Population: Yes (Arterial hypertension)56
PCV 13 Population: Yes (Dyslipidemia)53
PCV 13 Population: Yes (Diabetes mellitus)23
PCV 13 Population: Yes (History of neoplasm)13
PCV 13 Population: Yes (Ischemic heart disease)11
PCV 13 Population: Yes (Pneumonias in the last year)9
PCV 13 Population: Yes (Cardiac failure)2
PCV 13 Population: Yes (Chronic renal failure)1

11 further baseline measures are reported on the registry.

08

Study locations

11 sites
  • Hospital Universitario Son Espases
    Palma, Balearic Islands 07120, Spain
  • Hospital Universitari Mutua Terrassa
    Terrassa, Barcelona 08221, Spain
  • Hospital el Bierzo
    Ponferrada, LEÓN 24404, Spain
  • Hospital Universitario Fundacion Alcorcon
    Alcorcón, Madrid 28922, Spain
  • Hospital Clinico de Barcelona
    Barcelona, 08036, Spain
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 8041, Spain
  • Hospital Universitario de Burgos
    Burgos, 09006, Spain
  • Hospital Universitario de La Princesa
    Madrid, 28006, Spain
  • Hospital Gregorio Marañon
    Madrid, 28007, Spain
  • Hospital Clinico San Carlos
    Madrid, 28040, Spain
  • Complejo Asistencial de Salamanca
    Salamanca, 37007, Spain
09

References and documents

Study documents

  • Study protocol · Oct 31, 2016
  • Statistical analysis plan · Nov 7, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Jun 2022, 54 months.

Results were first posted in Aug 2024, 2 years 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2017
First posted
Sep 8, 2017
StartActual
Nov 30, 2017
Primary completionActual
Jun 16, 2022
CompletionActual
Jun 16, 2022
Results first posted
Aug 19, 2024
Last update
Aug 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03276754
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Nov 30, 2017
Primary completion
Jun 16, 2022
Completion
Jun 16, 2022
Results posted
Aug 19, 2024
Last update
Aug 19, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pneumococcal Infections →

Other studies from this sponsor

Pfizer →

Start the discussion