A Phase 3, Open Label, Trial, Evaluating the safety, tolerability and Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Children Previously Partially Immunized with Prevenar

Active, not recruiting

• Conditions: Healthy infants; MedDRA version: 9.1Level: LLTClassification code 10061353Term: Pneumococcal infection

• Registration Number: EUCTR2008-003631-21-SE
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Group 1. Male or female subject between the age of = 140 and = 196 days of age at time of enrollment. Group 2. Male or female subject between the age of = 336 and = 392 days of age at time of enrollment
2.The last dose of Prevenar must have been received at least 42 days before enrollment. Written documentation endorsed by a health professional showing that one dose of Prevenar and one dose of the NIP vaccinations have been given.
3.Child is determined to be in good health by medical history, physical examination, and judgment of the investigator.
4.Child is available for the entire study period and his/her parent/legal guardian can be reached by telephone
5.Parent/legal guardian must be able and willing to comply with all study procedures.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Previous vaccination with licensed or investigational pneumococcal vaccine other than Prevenar.
2.A contraindication to vaccination with pneumococcal conjugate vaccine.
3.Child had a previous anaphylactic reaction or allergy to any vaccine or vaccine-related component.
4.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5.History of culture-proven invasive disease caused by S.pneumoniae
6.Known or suspected immune deficiency or immune suppression.
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 disorder.
9.Received blood products or gamma globulin, in the last 3 months.
10.Participation in another interventional or investigational trial. Participation in purely observational studies is acceptable.
11.Infant or toddler who is a direct descendant (e.g. child or grandchild) of the study site personnel.
12.Any of the following major illness or conditions that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s participation in, and completion of, the study, or could preclude the evaluation of the subject’s response.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified