You are here

Study Evaluating Prevenar Vaccine in Healthy Infants

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-100 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female children 2 months of age (42 to 100 days) in good health.

- An informed consent must be signed by a parent or legal guardian following a detailed
explanation of participation in the study.

- Infants whose parent(s)/guardian(s) will be available for the entire study period.

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

- Hypersensitivity to any component of the vaccine, including diphtheria toxoid

- Infants with thrombocytopenia or any coagulation disorder that would contraindicate
intramuscular injection

- Infants with known or suspected impairment of immunologic functions including HIV or
those receiving immunosuppressive therapy.

Other exclusions apply.

NCT00276107
Pfizer
Completed
Study Evaluating Prevenar Vaccine in Healthy Infants

NEED INFO?

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

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Study Evaluating Prevenar Vaccine in Healthy Infants
An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
Biological: Prevenar
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2005
Not Provided

Inclusion Criteria:

  • Healthy male and female children 2 months of age (42 to 100 days) in good health.
  • An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
  • Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

  • Hypersensitivity to any component of the vaccine, including diphtheria toxoid
  • Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.

Sexes Eligible for Study: All
42 Days to 100 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00276107
0887X-101446
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2009

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 thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now