Study to Evaluate 13 Valent Pneumococcal Conjugate Vaccine (13vPnC) Vaccine Followed by 23-valent Pneumococcal Polysaccharide Vaccine (23vPS) Vaccine in Allogeneic Hematopoietic Stem Cell Transplant Recipients

November 30, 2018 updated by: Pfizer

A Phase 3, Open-label Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine Followed By 23-valent Pneumococcal Polysaccharide Vaccine In Recipients Of Allogeneic Hematopoietic Stem Cell Transplant Aged 2 Years And Older

People who have received an allogeneic hematopoetic stem cell transplant (HSCT) are more likely than other people to get ill from a germ called Streptococcus pneumoniae. Most people who have had a stem cell transplant are offered a vaccine called 23-valent pneumococcal polysaccharide vaccine (23vPS) to help protect against this germ. The purpose of this study is to evaluate the immune response in HSCT recipients who receive a 13 valent pneumococcal vaccine (13vPnC) followed by 23vPS.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
251

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Belgium, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Brugge, Belgium, 8000
        • Algemeen Ziekenhuis St.-Jan A.V.
      • Brussels, Belgium, 1200
        • Clinical University St Luc
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven (UZ) Gasthuisberg
      • Liege, Belgium, 4000
        • CHU Liège
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneuve-Rosemont
  • Czechia
      • Bmo, Czechia, 625 00
        • Fakultni nemocnice Brno/Interni hematoonkologicka klinika
      • Praha 5, Czechia, 15006
        • Fakultni nemocnice v Motole
  • France
      • Besancon, France, 25000
        • Hopital Jean Minjoz
      • Créteil, France, 94000
        • Hopital Henri Mondor
      • Créteil, France, 94010
        • Hôpital Henri Mondor, Pharmacie
      • PARIS Cedex 10, France, 75475
        • Hôpital Saint-Louis
      • PARIS Cedex 19, France, 75935
        • Hopital Robert Debre - Service Pharmacie
      • Paris, France, 75010
        • Hopital Saint Louis
      • Paris, France, 75019
        • CHRU Robert Debré
      • Paris Cedex 19, France, 75019
        • Hôpital Robert Debré
  • Germany
      • Berlin, Germany, 13353
        • Charite Universitaetsmedizin
      • Hamburg, Germany, 20246
        • Clinical Trial Center North MediGate GmbH
      • Hamburg, Germany, 20246
        • Klinik und Poliklinik fuer Paediatrische Haematologie und Onkologie
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg Eppendorf Clinical Trial Center North MediGate GmbH
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf, Onkologisches Zentrum
      • Jena, Germany, 07740
        • Universitätsklinikum Jena
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Muenster, Germany, 48149
        • "Universitaetsklinikum Muenster,
  • Netherlands
      • Utrecht, Netherlands, 3584 EA
        • UMC Utrecht, Wilhelmina Kinder Ziekenhuis
  • Poland
      • Gdansk, Poland, 80-952
        • Klinika Hematologii i Transplantologii
      • Krakow, Poland, 31-223
        • NZOZ "HIPOKRATES-II" Sp. z o.o.
      • Wroclaw, Poland, 50-345
        • Klinika Transplantacji Szpiku, Onkologii i Hematologii Dzieciecej
  • Spain
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28009
        • Hospital Universitario Infantil Nino Jesus
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Sweden
      • Goteborg, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset
      • Huddinge, Sweden, 141 86
        • Karolinska Universitetssjukhuset Huddinge
      • Lund, Sweden, 221 85
        • Universitetssjukhuset i Lund, Barnonkologen Avd 64
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital Huddinge
      • Uppsala, Sweden, 751 85
        • Akademiska Sjukhuset, Infektionskliniken
  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • New York
      • New Hyde Park, New York, United States, 11040
        • Steven And Alexandra Cohen Children's Medical Center Of New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Medical Center Research Pharmacy
      • New York, New York, United States, 10032
        • Columbia University Medical Center-Presbyterian Hospital Building
      • New York, New York, United States, 10032
        • Columbia University/Taub Institute Irving Center for Clinical Research
      • New York, New York, United States, 10032
        • New York-Presbyterian Morgan Stanley Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subject >=2 years of age.
  • Allogeneic HSCT for hematologic disorder.
  • Allogeneic HSCT with full myeloablative conditioning or reduced intensity conditioning.
  • Allogeneic HSCT approximately 3 to 6 months (91 days to 203 days) before enrollment.
  • Stable engraftment (absolute neutrophil count (ANC) >1000/µL; platelet count >50,000/µL).
  • Complete hematologic remission of underlying disease with very good partial remission (VGPR) acceptable in the case of lymphoma and myeloma.
  • Subject or parent/legal guardian expected to be available for the entire study and can be contacted by telephone.
  • Subject or parent/legal guardian must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
  • Hematological recovery as defined by ANC >1000/µL; platelet count >50,000/µL.
  • All female and male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control from signing of the ICF until for 3 months after the last vaccination.
  • Negative urine pregnancy test for all female subjects of child bearing potential.

Exclusion Criteria:

  • Autologous HSCT.
  • Receipt of donor lymphocyte infusions during the 28 days preceding enrollment.
  • Uncontrolled GVHD that in the opinion of the investigator would prevent the subject from participating in the study.
  • Lansky/Karnofsky Score <=60%.
  • Receipt of plasma products or immunoglobulins during the 60 days preceding enrollment.
  • Receipt of rituximab since HSCT.
  • Receipt of chemotherapy for relapse of underlying malignant disease since HSCT.
  • Human immunodeficiency virus (HIV) infection.
  • Lymphoproliferative disorder since HSCT.
  • Chronic illnesses with cardiac, pulmonary, renal, or liver failure that in the opinion of the investigator would prevent the subject participating in the study.
  • Vaccination with any licensed or experimental pneumococcal vaccine since HSCT.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would in the opinion of the investigator contraindicate intramuscular injection.
  • Participation in another study with ongoing use of an unlicensed investigational product from 28 days before study enrollment until the end of the study.
  • Participation in another study with ongoing use of a licensed investigational product that in the opinion of the investigator would interfere with the evaluation of the study objectives.
  • Permanent residence in a nursing home or other residential care facility.
  • Pregnant or breastfeeding female subject.
  • Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or is a member of the study personnel.
  • Receipt of advanced therapy medicinal products (ATMP) including gene therapy products, somatic cell therapy products, and tissue engineered products at any time before enrollment.
  • If information is available, - previous allergic or anaphylactic reaction to any vaccine or vaccine-related component in a stem cell donor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
Biological: 13vPnC

0.5mL 13vPnC dose will be administered intramuscularly into the left limb at visits 1,2,3 and 5.

Starting 3-6 months after HSCT 3 doses given at monthly intervals. 4th dose given 6 months after 3rd dose.

Biological: 23vPS
0.5mL dose of 23vPS will be administered intramuscularly at visit 6. 23vPS given 1 month after 4th dose of 13vPnC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in All Participants
Time Frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 3 in Pediatric, Adult and All Participants
Time Frame: 1 month after 13vPnC Dose 3
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 3 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
1 month after 13vPnC Dose 3
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Time Frame: 1 month after 13vPnC Dose 4
Antibody GMC for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) for pediatric, adult and all participants are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. Geometric means were calculated using all participants with available data for 1 month after 13vPnC Dose 4 blood draw. CI for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
1 month after 13vPnC Dose 4
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 3 in Pediatric and Adult Participants
Time Frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 3 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 3 blood draws.
Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 3
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From Before 13vPnC Dose 1 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Time Frame: Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC Dose 1 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before 13vPnC Dose 1 and after 13vPnC Dose 4 blood draws.
Before 13vPnC Dose 1 (pre-vaccination), 1 month after 13vPnC Dose 4
Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After 13vPnC Dose 3 to 1 Month After 13vPnC Dose 4 in Pediatric, Adult and All Participants
Time Frame: 1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4
GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month after 13vPnC Dose 3 to 1 month after 13vPnC Dose 4 were computed using the logarithmically transformed assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both after 13vPnC Dose 3 and after 13vPnC Dose 4 blood draws.
1 month after 13vPnC Dose 3, 1 month after 13vPnC Dose 4

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 1
Time Frame: Within 14 days after 13vPnC Dose 1
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 1
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 2
Time Frame: Within 14 days after 13vPnC Dose 2
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 2
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 3
Time Frame: Within 14 days after 13vPnC Dose 3
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 3
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Local Reactions: 13vPnC Dose 4
Time Frame: Within 14 days after 13vPnC Dose 4
Specific local reactions were prompted for each day, and reported using an electronic diary. Redness and Swelling were scaled as Any (redness present or swelling present); Mild (0.5 to 2.0 centimeters [cm] for participants aged 2 to <12 years and 2.5 to 5.0 cm for participants aged >= 12 years); Moderate (2.5 to 7.0 cm for participants aged 2 to <12 years and 5.5 to 10.0 cm for participants aged >= 12 years); Severe (greater than [>] 7.0 cm for participants aged 2 to <12 years and >10.0 cm for participants aged >= 12 years). Pain at injection site was scaled as Any (pain present); Mild (did not interfere with activity); Moderate (interfered with activity); Severe (prevented daily activity).
Within 14 days after 13vPnC Dose 4
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 1
Time Frame: Within 14 days after 13vPnC Dose 1
Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
Within 14 days after 13vPnC Dose 1
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 2
Time Frame: Within 14 days after 13vPnC Dose 2
Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
Within 14 days after 13vPnC Dose 2
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 3
Time Frame: Within 14 days after 13vPnC Dose 3
Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
Within 14 days after 13vPnC Dose 3
Percentage of Pediatric, Adult and All Participants Reporting Pre-specified Systemic Events: 13vPnC Dose 4
Time Frame: Within 14 days after 13vPnC Dose 4
Specific systemic events (fever >=38 degrees Celsius [C], fatigue, headache, vomiting, diarrhea, muscle pain, joint pain and use of medication to treat pain/fever) were prompted for each day, and reported using an electronic diary. Fatigue, headache, muscle pain and joint pain were scaled as: Any (symptom present); Mild (did not interfere with activity); Moderate (some interference with activity); Severe (prevented routine daily activity). Vomiting was scaled as: Any (vomiting present); Mild (1-2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (required intravenous hydration). Diarrhea was scaled as: Any (diarrhea present); Mild (2-3 loose stools in 24 hours); Moderate (4-5 loose stools 24 hours); Severe (>=6 loose stools in 24 hours).
Within 14 days after 13vPnC Dose 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 6115A1-3003
  • B1851022 (Other Identifier: Alias Study Number)
  • 2009-012087-13 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings