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Trial record 1 of 1 for:    115597
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Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545375
First Posted: March 6, 2012
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.

Condition Intervention Phase
Infections, Streptococcal Biological: Pneumococcal vaccine GSK2189242A Biological: Placebo Biological: Prevnar 13® Biological: PedvaxHIB® Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study to Determine Protective Efficacy Against Otitis Media and Assess Safety of an Investigational Pneumococcal Vaccine 2189242A in Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).

    Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP [AAP, 2004], as per the judgment of a treating physician or equivalent licensed medical professional:

    A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear[s] that resulted in interference with or precluded normal activity or sleep).



Secondary Outcome Measures:
  • Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).

    A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record.


  • Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).

    Definition of clinical AOM diagnosed and verified against modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional:

    1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is indicated by any of the following: a) Bulging of tympanic membrane, b) Limited or absent mobility of tympanic membrane, c) Air-fluid level behind tympanic membrane, d) Otorrhea OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane.


  • Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) [ Time Frame: From the administration of dose 1 up to Month 22 ]
    Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology.

  • Time to Occurrence of Any Draining Acute Otitis Media (AOM) [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).

    Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF.


  • Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T[year)]).

    Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF.


  • Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage [ Time Frame: From the administration of dose 1 up to Month 22 ]
    AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode.

  • Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).

    ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.


  • Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).

    ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds.


  • Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode. [ Time Frame: Any time from 2 weeks after the administration of dose 3 up to Month 22 ]

    Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/ sum of follow-up expressed in years (T[year)]).

    A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record.


  • Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort [ Time Frame: At 6-12 weeks of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22) ]
    Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed.

  • Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort [ Time Frame: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively ]

    Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL).

    Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies.


  • Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies [ Time Frame: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively ]
    Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues.

  • Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort [ Time Frame: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11). ]
    Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. Results at time point post booster (Month 22) were not analized at the time of posting; They will be added as soon as they are available.

  • Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F [ Time Frame: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] ]
    Antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL.

  • Antibody Concentrations Against Vaccine Serotypes 6C [ Time Frame: One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] ]
    No analysis was performed on antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.

  • Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes [ Time Frame: One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] ]
    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.

  • Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C [ Time Frame: One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] ]
    Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8.

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 4-day (Days 0-3) post-booster vaccination period ]
    Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose ]
    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 4-day (Days 0-3) post-booster vaccination period ]
    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses ]
    An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort [ Time Frame: Within the 31-day (Days 0-30) period post booster vaccination ]
    An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group.

  • Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Month 22 ]
    An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.


Enrollment: 1806
Actual Study Start Date: May 21, 2012
Study Completion Date: July 26, 2016
Primary Completion Date: July 26, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dPly-PhtD Group

Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.

PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.

At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

Biological: Pneumococcal vaccine GSK2189242A
4 doses administered intramuscularly
Biological: Prevnar 13®
4 doses administered intramuscularly
Biological: PedvaxHIB®
4 doses administered intramuscularly
Placebo Comparator: Control Group

Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age.

PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months.

At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate.

Biological: Placebo
4 doses administered intramuscularly
Biological: Prevnar 13®
4 doses administered intramuscularly
Biological: PedvaxHIB®
4 doses administered intramuscularly

Detailed Description:

The study will also evaluate the impact of the pneumococcal vaccine GSK2189242A on nasopharyngeal carriage in a subgroup of children called Carriage subgroup. Immunogenicity and reactogenicity of the pneumococcal vaccine GSK2189242A will be evaluated in another subgroup of children called Immuno/reacto subgroup.

Protocol Posting has been updated following Protocol Amendment 3, April 2012, leading to the addition of a secondary outcome measure.

Protocol Posting has been updated following Protocol Amendment 7, March 2017, to add serological testing for antibodies against the Hib polysaccharide PRP on samples collected 12 months following booster dose (Month 22) in the Immuno/reacto sub-cohort, in order to evaluate the long term persistence of immune responses to co-administered PedvaxHIB vaccine.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject who the investigator believes that their parent(s)/Legally Authorized Representative(s) (LARs) can and will comply with the requirements of the protocol.
  • A male or female American Indian infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
  • Voluntary, written informed consent obtained from the parents/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
  • Healthy subject as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of more than 35 6/7 weeks.

Exclusion Criteria:

For all infants:

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol starting from 30 days before each dose and ending 30 days after each dose of study vaccines, with the exception of licensed inactivated influenza vaccines and recommended pediatric vaccines.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Previous vaccination against S. pneumoniae.
  • Obstruction or anomalies of the nasopharyngeal space.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s) including latex.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Any medical or social condition which might interfere with the assessment of the study objectives in the opinion of the investigator.

For infants in the Immuno/reacto subgroup only:

• Previous vaccination against H. influenzae type b.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545375


Locations
United States, Arizona
GSK Investigational Site
Chinle, Arizona, United States, 86505
GSK Investigational Site
Fort Defiance, Arizona, United States, 86504
GSK Investigational Site
Whiteriver, Arizona, United States, 85941
United States, New Mexico
GSK Investigational Site
Gallup, New Mexico, United States, 87301
GSK Investigational Site
Shiprock, New Mexico, United States, 87420
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01545375     History of Changes
Other Study ID Numbers: 115597
First Submitted: March 1, 2012
First Posted: March 6, 2012
Results First Submitted: July 11, 2017
Results First Posted: September 12, 2017
Last Update Posted: September 12, 2017
Last Verified: July 2017

Keywords provided by GlaxoSmithKline:
nasopharyngeal carriage
safety
immunogenicity
US
Pneumococcal vaccine
efficacy
Streptococcus pneumoniae
infants

Additional relevant MeSH terms:
Infection
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs