Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

• Conditions: Healthy infants; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2006-001685-16-Outside-EU/EEA
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1.Aged 2 months (42 through 98 days) at the time of enrollment.
2.Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3.In good health as determined by medical history, physical examination, and judgment of the investigator.
4.Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 500
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Previous vaccination with licensed or investigational pneumococcal vaccine.
2.Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
3.A previous anaphylactic reaction to any vaccine or vaccine-related component.
4.Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
5.Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6.Known or suspected immune deficiency or suppression.
7.History of culture-proven invasive disease caused by S. pneumoniae.
8.Major known congenital malformation or serious chronic disorder.
9.Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
10.Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
11.Participation in another investigational trial. Participation in purely observational studies is acceptable.
12.Infant who is a direct descendant (eg. child or grandchild) of the study site personnel.

Study & Design

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