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Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

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ClinicalTrials.gov Identifier: NCT03548337
Recruitment Status : Active, not recruiting
First Posted : June 7, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

Condition or disease Intervention/treatment Phase
Vaccines Biological: 13vPnC Phase 4

Detailed Description:
A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE 4, RANDOMIZED, OPEN-LABEL TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 13- VALENT PNEUMOCOCCAL CONJUGATE VACCINE FORMULATED IN MULTIDOSE VIALS WHEN GIVEN WITH ROUTINE PEDIATRIC VACCINES IN HEALTHY INFANTS IN INDIA
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Active Comparator: 13vPnC with 2-PE from a MDV
Multi Dose Vial with preservative
Biological: 13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative

Active Comparator: 13vPnC without 2-PE in a PFS
Pre Filled Syringe without preservative
Biological: 13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative




Primary Outcome Measures :
  1. Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group. [ Time Frame: Within the 7 days after the first dose of the infant series ]
    Within the 7 days after the first dose of the infant series

  2. Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the second dose of the infant series ]
    Within the 7 days after the second dose of the infant series

  3. Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the third dose of the infant series ]
    Within the 7 days after the third dose of the infant series

  4. Incidence of local reactions and systemic events at the following time periods in the MDV group and in the PFS group [ Time Frame: Within the 7 days after the toddler dose ]
    Within the 7 days after the toddler dose

  5. Incidence of AEs in the MDV group and in the PFS group from the first dose up to 1 month after the infant series [ Time Frame: First dose up to 1 month after the infant series ]
    First dose up to 1 month after the infant series

  6. Incidence of AEs in the MDV group and in the PFS group from the toddler dose up to 1 month after the toddler dose [ Time Frame: From the toddler dose up to 1 month after the toddler dose. ]
    From the toddler dose up to 1 month after the toddler dose.

  7. Incidence of serious adverse events (SAEs) in the MDV group and in the PFS group from the first dose up to 1 month after the toddler dose [ Time Frame: First dose up to 1 month after the toddler dose. ]
    First dose up to 1 month after the toddler dose.

  8. Incidence of newly diagnosed chronic medical conditions in the MDV group and in the PFS group from 1 month after the infant series up to the toddler dose [ Time Frame: From 1 month after the infant series up to the toddler dose ]
    From 1 month after the infant series up to the toddler dose


Secondary Outcome Measures :
  1. The proportion of subjects with IgG concentrations equal to or above the defined threshold for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group

  2. The proportion of subjects with IgG concentrations equal to or above the defined threshold for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group

  3. The serotype-specific IgG GMC for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group

  4. The serotype-specific IgG GMC for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group

  5. The serotype-specific OPA GMT for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group

  6. The serotype-specific OPA GMT for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group

  7. The proportion of subjects achieving a serotype-specific OPA titer ≥ the lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the infant series in the MDV group and in the PFS group ]
    1 month after the infant series in the MDV group and in the PFS group

  8. The proportion of subjects achieving a serotype-specific OPA titer ≥ the lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured [ Time Frame: 1 month after the toddler dose in the MDV group and in the PFS group ]
    1 month after the toddler dose in the MDV group and in the PFS group



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.


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Ages Eligible for Study:   42 Days to 72 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian(s) has/have been informed of all pertinent aspects of the study.
  2. Parent(s)/legal guardian(s)/caregiver(s) willing and able to comply with scheduled visits, treatment plan, and other study procedures.
  3. Aged 6 weeks (42 to 72 days) at the time of vaccination. (The day of birth is considered Day 0.)
  4. Available for the entire study period and whose parent(s)/legal guardian(s)/caregiver(s) can be reached by telephone.
  5. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  6. Weight of 3.0 kg or greater at the time of vaccination.

Exclusion Criteria:

  1. Infant who is a direct descendant (child, grandchild) of

    • Investigator site staff members directly involved in the conduct of the study, or
    • Site staff members otherwise supervised by the investigator, or
    • Pfizer employees directly involved in the conduct of the study.
  2. Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
  3. Previous vaccination with licensed or investigational pneumococcal conjugate vaccine.
  4. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  5. Contraindication to vaccination with pneumococcal conjugate vaccine, or any other vaccine or vaccine component. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression, including known human immunodeficiency virus infection.
  7. Major known congenital malformation or serious chronic disorder.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb's palsy.
  9. Other acute or chronic medical condition including recent laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  10. Receipt of blood products or gamma globulin (including hepatitis B immunoglobulin and monoclonal antibodies, eg, Synagis).

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): NCT03548337


Locations
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India
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India, 380016
Manipal Hospital
Bengaluru, Karnataka, India, 560017
KEM Hospital Research Centre
Pune, Maharashtra, India, 411 011
Bharati Vidyapeeth University Medical College
Pune, Maharashtra, India, 411043
Sri Ramachandra Hospital
Chennai, Tamil NADU, India, 600116
Kanchi Kamakoti Childs Trust Hospital
Chennai, Tamil Nadu, India, 600034
Sir Ganga Ram Hospital
New Delhi, India, 110060
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03548337     History of Changes
Other Study ID Numbers: B4671004
INDIA INFANT MDV ( Other Identifier: Alias Study Number )
2016-005134-29 ( EudraCT Number )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs