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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

Last updated on January 24, 2020

FOR MORE INFORMATION
Study Location
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, 380016 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-72 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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).

NCT03548337
Pfizer
Not yet recruiting
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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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines
Intervention  ICMJE Biological: 13vPnC
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
Study Arms  ICMJE
  • Active Comparator: 13vPnC with 2-PE from a MDV
    Multi Dose Vial with preservative
    Intervention: Biological: 13vPnC
  • Active Comparator: 13vPnC without 2-PE in a PFS
    Pre Filled Syringe without preservative
    Intervention: Biological: 13vPnC
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 25, 2019)
299
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
300
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 42 Days to 72 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03548337
Other Study ID Numbers  ICMJE B4671004
INDIA INFANT MDV ( Other Identifier: Alias Study Number )
2016-005134-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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