A clinical study to test the safety, tolerability and immune response of a vaccine against pneumococcal bacteria, presented in a multidose vial given with other vaccines to healthy infants.

• Conditions: MedDRA version: 17.1Level: PTClassification code 10061353Term: Pneumococcal infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2012-000482-21-Outside-EU/EEA
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-10
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject’s parent(s)/legal guardian(s) has been informed of all pertinent aspects of the study. If the subject’s parent(s)/legal guardian(s) is illiterate they must thumbprint the ICD and it must be signed and dated by an impartial witness who was present throughout the entire informed consent process.
2. Aged 42 to 70 days at time of enrollment.
3. Available for entire study period.
4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
5. Parent(s)/legal guardian(s) is willing and able to comply with scheduled visits and other study procedures.
6. Weight of 3.5 kg or greater at the time of enrollment.
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
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.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal conjugate vaccine.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
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. Receipt of blood products or gamma-globulin since birth and until the blood draw approximately 1 month after the last dose of 13vPnC.
10. Other severe acute or chronic medical or psychiatric condition or 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.
11. Participation in other studies within 28 days before the current study begins and/or during study participation. Participation in observational studies, and interventional studies such as those where a nasopharyngeal swab or urine sample may be collected, are permitted.
12. Subjects who are direct descendents (child or grandchild) of investigational site staff members or Pfizer employees directly involved in the conduct of the trial.

Study & Design

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