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13-valent Pneumococcal Conjugate Vaccine Study in Adults and Children in India

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.
 
ClinicalTrials.gov Identifier: NCT02034877
Recruitment Status : Completed
First Posted : January 14, 2014
Results First Posted : July 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
This study is to describe the safety and immunogenicity of 13vPnC in Indian adults 50 to 65 years of age and in Indian children 6 to 17 years of age.

Condition or disease Intervention/treatment Phase
Prevention of Pneumonia and Invasive Disease Caused by the Serotypes in 13vPnC Biological: 13-valent Pneumococcal conjugate vaccine Procedure: Blood sample collection Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1200 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Biological: 13-valent Pneumococcal conjugate vaccine
1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1

Procedure: Blood sample collection
10 mL of blood will be collected just before and approximately 1 month after vaccination.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination [ Time Frame: Within 1 month after 13vPnC vaccination ]
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.

  2. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
    Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

  3. Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
    Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

  4. Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination, 1 month after 13vPnC vaccination ]
    GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs 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 and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

  5. Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination [ Time Frame: Before 13vPnC vaccination ]
    Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

  6. Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination [ Time Frame: 1 month after 13vPnC vaccination ]
    Percentage of participants achieving serotype-specific pneumococcal OPA titer >=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Indian adults subjects between 50 and 65 years of age and indian children between 6 and 17years of age, determined by clinical judgment to be eligible for 13vPnC vaccination.

Exclusion Criteria:

Any contraindication to 13vPnC vaccination, vaccination with any pneumococcal vaccine within the last year

Contacts and Locations
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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): NCT02034877


Locations
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India
King George Hospital
Visakhapatnam, Andhra Pradesh, India, 530002
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India, 380016
S.B.K.S Medical Institute & Research Centre
Vadodara, Gujarat, India, 391760
M.S. Ramaiah Cliical Research Centre, M.S. Ramaiah Medical College & Hospitals
Bangalore, Karnataka, India, 560054
M.S. Ramaiah Medical College and Hospitals
Bangalore, Karnataka, India, 560054
Sushruta Multispeciality Hospital & Research Centre Pvt. Ltd.
Hubli, Karnataka, India, 580021
Cheluvamba Hospital
Mysore, Karnataka, India, 570001
Niramaya Hospital
Chinchwad Pune, Maharashtra, India, 411019
Chopda Medicare and Research Centre Pvt. Ltd
Nashik, Maharashtra, India, 422005
Supe Heart & Diabetes Hospital and Research Centre
Nasik, Maharashtra, India, 422002
Medipoint Hospitals Pvt. Ltd.
Pune, Maharashtra, India, 411007
Padmashree Dr. D. Y. Patil Medical College
Pune, Maharashtra, India, 411018
Christian Medical College
Vellore, Tamilnadu, India, 632 004
Samvedna Hospital
Varanasi, Uttar Pradesh, India, 221005
Bhatia Hospital
Mumbai, India, 400007
Orange City Hospital and Research Institute
Nagpur, India, 440015
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02034877    
Other Study ID Numbers: B1851140
2014-001174-34 ( EudraCT Number )
First Posted: January 14, 2014    Key Record Dates
Results First Posted: July 1, 2016
Last Update Posted: July 1, 2016
Last Verified: May 2016
Keywords provided by Pfizer:
13-valent pneunococcal conjugate vaccine
pneumococcal disease prevention; safety and immunogenicity study
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs