Study Evaluating Pneumococcal Vaccine in Healthy Infants

A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants

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.

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®).