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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 February 16, 2019

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.
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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.
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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
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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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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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]

Call Now