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Study Evaluating Pneumococcal Vaccine in Healthy Infants

NCT ID: NCT00205803

Last Updated: 2012-08-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.

Detailed Description

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Conditions

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Healthy Subjects Pneumococcal Infections

Keywords

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Infant Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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13vPnC

Group Type EXPERIMENTAL

13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

7vPnC

Group Type ACTIVE_COMPARATOR

7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

Intervention Type BIOLOGICAL

Interventions

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13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

7-Valent Pneumococcal Conjugate Vaccine (7vPnC)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
2. In good health as determined by medical history, physical examination and judgment of the investigator,
3. Subject must have been born ≥36 weeks of gestational age,
4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

Exclusion Criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine,
2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
4. 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 palsy,
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
6. History of culture-proven invasive disease caused by S. pneumoniae,
7. Previous anaphylactic reaction to any vaccine or vaccine components,
8. Major known congenital malformation or serious chronic disorders,
9. Participation in another investigational study (however, observation-only trials are permitted),
10. Known or suspected immune deficiency/suppression,
11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; eg, Synagis®).
Minimum Eligible Age

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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New York, New York, United States

Site Status

Countries

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United States

References

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Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.

Reference Type DERIVED
PMID: 20435707 (View on PubMed)

Other Identifiers

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6096A1-003

Identifier Type: -

Identifier Source: org_study_id